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Concept Life Sciences

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High Peak, GB

About Concept Life Sciences

Concept Life Sciences is a knowledge-based, science-led business providing a wide range of innovative and integrated solutions to clients in the pharmaceutical, biotechnology, food, agrochemical, petrochemical, chemical and consumer products sectors. We also work closely with academic groups. Formed in 2014, our business has expanded through a mix of organic growth and targeted acquisition.

Today, we are a people centric organisation working to solve complex human health challenges. We address these through continuous innovation, exceptional science and the highest customer service. We accelerate the customer’s discovery and development through applying our expertise to their challenges. We are home to more than 400 employees, with locations across the UK.  

We share a common focus on problem solving, quality, collaboration, communication and flexibility. By bringing together state-of-the-art equipment, automated data management and interpretation by highly experienced scientists, we have created a business that is greater than the sum of its parts.  Our services include: 

  • Bioanalysis & biomarkers
  • Safety & toxicology
  • Specialist Histology
  • GMP & Manufacturing
  • In vitro discovery services; oncology, immunology, neuroscience
  • Chemistry; synthetic, analytical, process R&D
  • Analytical services


Our Services (65)


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Salt Screening

Price on request

To support the quick movement from early discovery through to first-in-man studies, we have developed a small scale focused salt screen to complement the larger and more exhaustive salt screens which are typically available. This screen looks to produce a limited number of alternative forms quickly and to characterise their performance (solubility, melting point, moisture uptake, structure) in order to provide an optimal (but potentially not final) salt form for the first trial.

In addition to maintaining XRPD, DSC, TGA, DVS and our excipient solubility screen to support that work, we have also teamed up with an industry expert in the field, who provides hands on guidance and consultancy support throughout the programme

Malvern XRPD Differential Scanning Calorimetry (DSC) TGA API

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Isothermal Titration Calorimetry (ITC)

Price on request
  • A label-free, in-solution method measuring binding affinity, stoichiometry, thermodynamics and kinetics
  • Interacting partners can be small molecules, RNA/DNA, lipids, carbohydrates and proteins (including membrane-bound targets) – no molecular weight limitations 
  • Gold standard technique as no labelling, immobilisation or heating involved
  • Only technique to directly measure enthalpy and entropy of binding 


ITC label free binding affinity

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Surface Plasmon Resonance (SPR)

Price on request
  • SPR universally measures binding in real time, giving accurate affinity and kinetic information at a throughput of 100’s compounds/day .
  • Binding partners can be whole cells, viruses, membranes, antibodies, proteins, peptides, nucleic acids, lipids or small molecules.
  • Label-free technology where response is proportional to the mass on the surface with a sensitivity from Mw 50 Da upwards.
  • One of the interactants (usually the protein) is immobilised onto a sensor chip surface and the other interactant (usually compound) is flowed over.


Biacore 8000 Biacore T-200 Proteins Antibodies Peptides Small molecules lipids viruses Show 8 more tags Show less

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Multiple Sclerosis Animal Models

Price on request

We offer pre-clinical animal models for MS, which focus on the autoimmune and inflammatory component of the disease as well as the myelin damage and repair.

  1. Cuprizone and LPC Models
  2. EAE model 

The cuprizone and lysophosphatidylcholine (LPC) rodent models induce demyelination followed by a recovery period of remyelination. The cuprizone model results in global demyelination whereas the LPC induced model creates a focal lesion.


Experimental autoimmune encephalomyelitis (EAE) is a T cell-driven disease of the central nervous system in mouse and is considered the gold standard model for brain inflammation and demyelination studies.

flow cytometry Experimental autoimmune encephalomyelitis cuprizone lysophosphatidylcholine Custom Assays multiplex CNS/Neurology Neurodegeneration Neurology Multiple sclerosis (MS) Show 10 more tags Show less

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Induced Pluripotent Stem Cell (iPSC) Culture

Price on request

We offer a suite of tailored iPSC in vitro assays, working closely with you to develop custom human cell models for proof-of-concept (POC) and target validation assays specific for your therapeutic target. We can generate human CNS cells from both embryonic stem cells or disease specific iPSC’s that have physiologically relevant genetic background and disease-specific phenotypes, for use in both mono- and co-culture assay systems with tailored readouts, accelerating your best route to clinic.

Induced Pluripotent Stem Cells CNS/Neurology Neurology

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Cell-Based Assays

Price on request

We can set up integrated screening cascades to expedite lead discovery and optimisation. We can also validate cell- based and non cell-based assays for primary pharmacology screening and mechanism of action.  Our teams have a strong background in assay development and optimisation of target based and phenotypic screens on electrophysiology platforms. We can access human derived IPSc stem cells for the development of translationally relevant assays. 

We believe it is this integration of pharmacology, ADMET and DMPK that is so important for the development of PK/PD relationships.

Custom Assays Custom Cell-Based Assay Development CNS/Neurology Immuno-Oncology Immunology

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Preclinical Histology

Price on request

Our team has the experience, expertise and specialist equipment to deliver technically demanding projects. Our ethos is to work closely with you to understand your histology requirements, and to tailor services specifically to meet your needs for:

  • Histology 
  • Human tissue samples
  • Multiplex IF/IHC
  • RNAscope
  • Image analysis
  • Clinical trial support

All our staff are GCP and/or GCLP trained and work to GCP for labs standards. A QA audit programme is in place, which includes study-based, process-based and annual facility inspections.

Located in the Edinburgh BioQuarter, a unique geographical location with easy access to multiple expert institutions, we can source local, ethically approved human tissue for most types of cancer. Each cohort of samples is reviewed by a Senior Academic Clinical Histopathologist who can respond to bespoke tissue request

multiplex immunohistochemistry Immunofluorescence RNAscope Image analysis

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NanoString nCounter Analysis

Price on request

we work closely with you to provide rational and stepwise discovery programs, which will provide insight into the signalling pathways, regulation of downstream genes and the target cell types of your drug candidate. Our NanoString and NGS services can help inform on your best route to clinic. Key advantages of NanoString: 

  • Profile up to 800 RNA (mRNA, microRNAs, SNVs, CNVs), DNA or protein targets 
  • Off-the-shelf and custom panels for Oncology, Immunology and Neuroscience
  • Less precious sample material required
  • Optimised for difficult sample types e.g. FFPE, tissue, crude-cell lysates and biofluids
  • Human and mouse
  • Accurate & faster than qPCR (no amplification steps), simpler than NGS 

NanoString is available as a readout to our custom in vitro, in vivo and ex vivo assay systems. Alternatively, send us your samples for RNA extraction or as pre-extracted RNA, we tailor to you.

qPCR Nanostring mRNA microRNA SNV CNV FFPE tissue Human Mouse Show 9 more tags Show less

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Immunology Animal Models

Price on request

We know using in vivo mouse models is an important translational step in your immuno-oncology pre-clinical phases. We offer several syngeneic tumour models e.g. B16.OVA and Lewis Lung models that can be coupled with many of our custom in vitro assay readouts to allow detailed MOA interrogation within the TME.

Our immunology and specialist histology expertise ensures robust analysis and reporting of your in vivo model. We can perform histological analysis from routine H&E up to 9-plex multiplex immunofluorescent staining on a single section. Our flow experts can design customised panels where required and we can also support with ELISA, multiplex, qPCR and NGS readouts.

multiplex ELISA qPCR NGS Custom Assays Immunology Immuno-Oncology Show 7 more tags Show less

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Phagocytosis Assay

Price on request

we have a range of phagocytosis-based assays to help you understand the interaction between your compound or biologic and the phagocytic cells of the immune system, taking you to clinic faster. Our phagocytosis assays, which can be tailored to your requirements, include: 

  • Clearance of dead or apoptotic cells (efferocytosis) 
  • Antibody-dependent cellular cytotoxicity (ADCP)
  • Blocking of phagocytosis signals (e.g. CD47)
  • Uptake of bacteria or yeast bioparticles

neutrophils macrophages Monocytes DCs

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Mixed Lymphocyte Reactions

Price on request

Mixed lymphocyte reaction (MLR) assays can be used to understand the effects of biologics or small molecules on T cell activation, an important immune response in the tumour microenvironment (TME). There are different MLR protocols available: 

  • “one-way” or “two-way” MLR systems using PBMCs 
  • Autologous MLR assay using monocyte-derived dendritic cells (Mo-DC) and CD4+ T cells from the same donor, and anti CD3/CD28 as the stimulator
  • Allogenic MLR assay using Mo-DC and CD4+ T cells from HLA-mismatched donors (immature or mature)

We can advise on the most suitable MLR to understand your drug candidate mechanism of action (MOA), and tailor the assay accordingly.

We offer both custom and standard assay readouts, such as cytokine expression (e.g. IFN-γ), T cell activation (e.g. CD80), proliferation (e.g. CFSE) and cell cycle (e.g. Ki-67) measured by ELISA and/or flow cytometry.

ELISA Flow cytometry CD4+ T cells Cytokines

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Inflammation Animal Models

Price on request

we understand investigating the MOA of your compound using an in vivo model is a requirement on your route to clinic. We have a range of in vivo and ex vivo platforms which can be leveraged to study the effect of your drug candidate in an inflammatory environment.

We work closely with you to select the most suitable approach based on the immune cells or disease of interest to better understand your compound or biologic.

Our customisable models can study but are not limited to the following:

Antigenic challenge

Autoimmune inflammation of the CNS (EAE)

Delayed-type hypersensitivity (DTH)

Macrophage biology

Liver disease

We offer standard and tailored readouts ensuring robust MOA interrogation of your drug candidate. Our histology experts offer standard H&E for histological analysis through to specialist multiplex immunofluorescent staining, and our immunology expertise allows for tailored FACS analysis, ELISA, qPCR and NGS readouts.

Experimental autoimmune encephalomyelitis (EAE) Delayed-type hypersensitivity Liver Disease in vivo ex vivo FACS ELISA qPCR NGS Show 9 more tags Show less

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Cytotoxicity Assays

Price on request

We understand your reasons for investigating cytotoxicity. Whether you need to screen your compound library to find cytotoxic IO drug candidates to take forward, or screen your “hits” for unwanted cytotoxic effects, our immunology experts work closely with you to determine if your compound impacts the viability of both immune and non-immune cells, including tumour cells.

Using our primary cell know-how and custom in vitro assay approach, we can assess apoptosis and necrosis of mixed or isolated cell populations such as PBMCs, T cells, B cells, NK cells, monocytes and DCs in mono- or co-culture set up, with both standard and custom readouts e.g. IncuCyte Live-Cell Analysis System, flow cytometry, ELISA and qPCR.

We also offer Killing Assays to investigate targeted cell death mechanisms.

IncuCyte S3 ELISA qPCR Flow cytometry

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Human Hepatocytes

Price on request

Drug-induced liver injury (DILI) is one of the main causes of investigational new drug (IND) failure in clinic. We understand the importance of knowing the effects your test compounds or biologics have on hepatocytes early in discovery.

Hepatocytes play an essential role in toxin and drug metabolism and clearance. We use primary hepatocytes (human, rat or mouse) in our in vitro assays to predict drug hepatotoxicity. Our primary cell assay systems evaluate the impact of your drug candidate on hepatocyte proliferation, metabolism and enzyme activity. 

We can tailor a study that meets your specific research needs. We can customise the experimental design to understand the MOA of your drug candidate. We work closely with you to build a stronger data package and speed up your route to clinic.

Drug-induced liver injury mechanism of action Human Mice rats

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Human Keratocytes

Price on request

We know the importance of understanding the impact of your novel therapeutic candidate on keratinocyte function and their interaction with immune cells to advancing your discovery program.

Our customisable in vitro skin assays can evaluate keratinocyte proliferation, migration, differentiation, and cytokine production. We can source human primary keratinocytes from healthy and diseased patients such as Psoriasis and Atopic Dermatitis as well as various cell lines to provide translational models.

Psoriasis Atopic dermatitis keratinocyte

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T Cell Activation and Proliferation Assays

Price on request

We offer a variety of T cell assays to help you study the nuances of T cell interaction with your drug candidate. Whether you are developing anti-inflammatory or anti-cancer therapies, our comprehensive panel of T cell assays will provide you with valuable efficacy data.

Whatever your research needs, we can tailor a package to suit you. Alone or in combination with other cells, we offer:

  • T cell polarisation assay 
  • T cell stimulation assay
  • T cell killing assay
  • Treg suppression assay
  • Antigen specific T cell assay
  • Mixed lymphocyte reaction (MLR)

Inflammation Cancer t cells Immunology

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Drug Discovery & Development

Price on request

Our expertise in medicinal chemistry, specialist chemistry, translational biology, ADMET & DMPK, can add value to a discovery programme and enhance its probability of success. At the same time our scientific knowledge, skills, equipment and techniques play a vital role in turning drug candidates into first-in-man formulations. We are experts in method development, API characterisation, screening, stability studies and pre-clinical formulation.

Whatever the requirement, we provide support at every stage of the discovery and development process.


medicinal chemistry Synthetic Chemistry process chemistry Hit ID Hit to lead ADME DMPK drug discovery and toxicology Small molecules CNS/Neurology Immuno-Oncology Immunology Oncology Show 13 more tags Show less

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Fragment Screening

Price on request

We offer state of the art fragment-based drug discovery services:

  • Lead-Like/Hit quality/High diversity/Unique fragment collection
  • Fragment screening strategies (e.g. 8K SPR, ITC…)
  • A strong collaboration with X-Ray crystallography experts
  • Drug discovery expertise across a range of therapeutic areas and target classes to rapidly progress FBDD campaigns

Drug Discovery Hit ID Hit to lead Lead optimization

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Medicinal Chemistry

Price on request

Concept Life Sciences’ expertise in medicinal chemistry spans numerous therapeutic areas, taking the drug discovery process all the way from hit generation to Phase I clinical studies. We have a proven track record in producing robust candidates suitable for ‘proof-of-concept’ testing in vivo. Our medicinal chemists have made key contributions to drugs undergoing clinical development and many of our scientists are listed as inventors on a variety of patents.

Our highly-experienced teams deliver on project goals while ensuring complete client confidentiality and protection of Intellectual Property (IP).

As we progress from hit generation to scaffold-hopping, hit-to-lead and lead optimisation, our talented medicinal chemists work closely with our computational chemistry services. This ensures timely, practical hypothesis testing is delivered in line with the project’s goals.

Oncology immuno-0n CNS/Neurology ADCs PROTAC Small molecules kinases GPCR SAR Hit ID Hit to lead Lead optimization kinase GPCR Show 14 more tags Show less

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Custom Cell-Based Assay Development

Price on request

Development of biochemical, biophysical, cell-based and phenotypic assays for pharmacological characterisation of compounds.

  • Biochemical assays: enzyme kinetics, selectivity assays
  • Biophysical assays: SPR, ITC, MST, TSA, AUC
  • Cell-based assays: MOA, reporter, cell cycle, phenotypic (cytotoxicity, apoptosis, proliferation), whole blood and PBMC assays for immune cell isolation, co-culture and immuno-modulation assays

ITC SPR MST Drug Mechanisms of Action Studies Biochemical Assays Biophysical Assays Show 6 more tags Show less

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ADME/DMPK Studies

Drug Metabolism and Pharmacokinetics
Price on request

*Please check our RESOURCE tab for detailed assay cards*

Our highly experienced ADMET team would be happy to design a tailored service to your requirements, guiding you on the best techniques with automated data management and expert interpretation. We can also support each stage of in vivo PK projects from study design to final report.

We pride ourselves in our turnaround time as we recognise the critical need for speed in decision-making, we can turnaround data in 5 business days. We also aim to minimise compound usage and costs.

OUR IN VITRO ADMET SERVICES INCLUDE:

PHYSICOCHEMICAL PROPERTIES

·       Solubility (pH 7.4 or Multiple pH on request, FaSSIF, FeSSIF, simulated gastric fluid)

·       Log D (shake-flask, pH7.4,)

·       CHI Log D

·       In vitro non-specific binding

·       Chemical stability

PERMEABILITY TO FACILITATE ABSORPTION PREDICTION

·       Caco permeability (plus BCRP and/or BCRP substrate identification)

·       MDCK-MDR1  (Pgp substrate identification)

·       MDCK-BCRP  (BCRP substrate identification)

DISTRIBUTION

·       Plasma protein binding (multiple species)

·       Whole blood binding

·       Brain tissue binding

·       Microsome binding

·       Intestinal tissue binding

METABOLISM

·       Microsome stability

·       Hepatocyte stability

·       Plasma stability

·       S9 stability

·       GSH trapping

·       Metabolite profiling and identification

DRUG-DRUG INTERACTIONS

·       CYP inhibition

·       Time-dependant inhibition (single concentration)

·       PXR, AhR, CAR Nuclear Hormone Receptor Activation

·       CYP induction in rat and human hepatocytes

CYTOTOXICITY

·       HepG2 Various end points (LDH, Neutral red, MTS)

·       Mitochondrial toxicity


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Bioanalytical Assays

Price on request

Concept Life Sciences offer LC-MS/MS based bioanalysis services within regulatory, in both preclinical GLP and clinical GCP environments.  We have a highly skilled technical team, underpinned with comprehensive regulatory experience, as well as direct scientist to scientist workflows to minimise bottlenecks and expedite sample turnaround and data delivery.

• Removing lab variability from Discovery PK through to Phase IIb clinical

studies (D2C)

• Tailoring rapid, fit-for-purpose methodology to support non-regulatory

studies (PK, MTD and DRF)

• Development of fit-for-purpose methods into fully FDA and EMEA

compliant assays to support

• Biofluid and tissue analysis

• Microsampling techniques in preclinical space

• Supporting metabolite profiling and ID across Discovery to Clinical paradigm

Sciex QTRAP 6500+ LCMS/MS Agilent 5977 GC-MS Waters G2-XS UPLC (Waters) microsampling ELISA Ion Mobility Metabolite Profiling Small molecules Peptides Biomolecules Show 12 more tags Show less

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Synthetic Chemistry

Price on request

Concept Life Sciences is a leading provider of synthetic chemistry services. Our expertise extends to chiral synthesis, controlled substances, natural product synthesis and nucleoside, nucleotide and carbohydrate chemistry.

We offer milligram to kilogram chemistry synthesis for new compounds, APIs, intermediates, reference compounds, focused libraries, stable labelled compounds, competitor compounds, scaffolds, building blocks, analogues, drug metabolites and impurities. We also specialise in developing custom chemical synthesis solutions designed to overcome specific challenges.

chiral synthesis Custom Synthesis Carbohydrate Synthesis Organic Synthesis impurity synthesis Small molecules Peptides PROTAC ADCs API LINKERS Scaffolds Building blocks milligram gram kilogram Ozonolysis Chiral Separation Hydrogenation natural products Show 19 more tags Show less

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Process and Scale-Up Chemistry

Price on request

Using the latest techniques the experienced PR&D team at Concept work directly with clients to optimise routes for compound synthesis to:

  • Identify and remove inefficiencies
  • Reduced raw material costs
  • Compress timelines
  • Develop safe, scalable route

Typical types of chemistry covered include chlorinations, oxidations, malodorous, low temperature reactions, coupling reactions, exothermic chemistry, pyrophoric reactions and boronic ester formation.

gram kilogram

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Bioconjugation/Chemical Crosslinking

Price on request

OUR SPECIFIC CAPABILITIES INCLUDE:

  • Synthesis and characterisation of toxophores/warheads, large macrocycles
  • Synthesis of payloads and linker fragments (see examples)
  • Bioconjugation chemistry
  • Purification and analysis
  • Drug Antibody Ratio (DAR) by MS or UV
  • Intact analysis HIC/UV and SEC- LC/MS
  • Positional isomer determination
  • Determination of Extinction Coefficient of drug and antibody
  • Aggregation by SDS-PAGE or by SEC-UV
  • Centrifugation, ultrafiltration, sample dilution

bioconjugation antibody conjugation

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Antibody-Drug Conjugate (ADC) Analysis

Price on request

OUR SPECIFIC CAPABILITIES INCLUDE:

  • Quantitation -UV (A280) - Thermo Scientific Nanodrop
  • Characterisation - SDS-PAGE
  • DAR, drug load distribution and glycan profiling - Native and subunit analysis by LC-UV/MS
  • Post-translational and chemical modification, conjugation site occupancy ratio, sequence identity - Peptide mapping
  • Bioanalysis - In vitro metabolic stability (rodent serum)

antibody conjugation

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Chemistry, Manufacturing and Controls (CMC)

Price on request

We provide world leading integrated solutions focused around de-risking development of NCE’s, through chemistry and pharmaceutical development to biotechs, spinouts, medium and large pharma clients. Our detailed approach to development ensures that a full data package is available to reduce risk before moving to manufacture:

  • Route optimisation and process development 
  • Material characterisation
  • Preformulation
  • Screening – salt screening, solubility assessment
  • Formulation development
  • Formulation assessment –confirmation of bioavailability, pk profile
  • Manufacturing process development– analytical method validation, engineering batch
  • GMP batch manufacture, release testing, GMP stability

kilogram GMP Manufacturing API OEB4 Manufacturing and controls (CMC) Drug Preformulation HIGH POTENT API Small molecules Show 8 more tags Show less

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Polymorphism Screening

Price on request

Our primary goal in polymorph screening is typically to identify the most thermodynamically stable polymorph under expected ambient and processing conditions. Getting to that point often requires a structured screen, but tailored to the specific goals of the development team.

The solubility of the compound in each target solvent utilised in the stable polymorph screen is also assessed during this programme. This protocol is supported by the wide range of analytical equipment on site able to quickly characterise the differences between the identified forms (XRPD, FTIR, DSC, TGA, polarised light microscopy, DVS, Raman spectroscopy, Headspace GC and Karl Fischer). Further analytical techniques are then available to determine the solubility/bioavailability of the found forms like low volume dissolution.

DSC TGA XRPD FTIR Raman Spectroscopy Karl Fischer titration Karl Fischer Solid Form Screening Polymorph Screening Polymorphism Polymorph XRD Solid Form Salt Screening Solubility Polymorph Identification XRPD XRD Show 18 more tags Show less

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Drug Preformulation

Price on request

We offer a comprehensive service for the formulation, development and GMP sample production for pre-clinical trial materials. We test and release formulations according to development specifications and produce batches under GMP conditions ready for transfer to study teams.

  • Pre-formulation / Pre-nomination support
  • Extensive API and product characterisation
  • Solubility in aqueous, organic, biorelevant media
  • pKa, LogP/D outputs, Drug absorption modelling
  • Scale up in GMP for pre-clinical administration
  • Screens: Salt/Polymorph/Co-crystal
  • Tablets, capsules, liquids, suspensions, pulmonary (pMDI / DPI)
  • Powder blending and release for tox trials

GMP API micronisation nanosuspension pre formulation pre clinical formulation nanoparticles Show 7 more tags Show less

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Analytical Chemistry Services

Price on request

Fully GLP Compliant and FDA Approved* Concept Life Sciences has a range of advanced analytical chemistry services to help you achieve your goals https://bit.ly/3f7RGda


Our unique blend of advanced materials characterisation, chromatographic, elemental and compendial test methods provide comprehensive analytical solutions from product characterisation and registration through to commercial release testing.

Good Laboratory Practice GMP FDA ISO 9001

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GMP Certification

Good Manufacturing Practice Certification
Price on request

Concept Life Sciences has wide experience in analytical method development, validation and verification for the pharmaceutical, medical device and healthcare industry sectors including working with clients carrying out method validation work to meet regulatory requirements, and for internal cGMP needs. We agree an approach with the client, usually in discrete costed sections to control the overall programme cost. The work can include analytical method development from first principles or changing/improving existing methods. Our experience includes, small and large molecules, also polymers, plastics, nicotine-based products, bone substitute and similar medical device products. We are happy to produce our own Validation Protocols, or work to formats provided by our client. After execution of the protocol results are provided as a final method validation report in line with the protocol, with the method details included or referenced. Typical test method validation parameters are based on ICH guidelines (e.g. robustness, linearity, limit of detection, limit of quantitation, accuracy, precision, and specificity) or as agreed with the client.  Method verification is used to demonstrate that a standardised published method can be run effectively in each laboratory.  The requirements for method verification are less stringent than for validation but the principle approach is the same. A formal Verification Protocol with defined acceptance criteria is produced and agreed with the client. The verification is then executed and reported in a Verification Report, with the method details included or referenced.  The extent of the verification will depend on the procedural and sample complexity but as a minimum the verification will require demonstration that the performance parameters (for example system suitability tests) specified in the method have been met with the matrices to which the method is being applied (typically analyte recovery assessment).  For HPLC assay methods it is sometimes necessary to carry out a limited linearity assessment due to flow cell differences.

cGMP cGMP-compliant Analytical validation studies Analytical Method Development Method Development

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Analytical Method Development

Price on request

Analytical method development, verification and validation to cGMP

We have wide experience in analytical method development for the the pharmaceutical, medical device and healthcare industry sectors, including working with clients carrying out method validation work to meet regulatory requirements, and for internal cGMP needs.
Analytical Method development
We agree an approach with the client, usually in discrete costed sections to control the overall programme cost. The work can include developing a test method from scratch, or changing/improving existing methods. Our experience includes, small and large molecules, also polymers, plastics, bone substitute and similar medical device products, as well as nicotine-based products.

WE DEVELOP METHODS IN THE FOLLOWING BROAD AREAS:
Liquid and gas chromatography (for example, for stability indicating methods, residual solvents)
Materials characterisation/solid state
Wet chemistry
All projects are documented with a final report, including a final write up of the method, and typically with inclusion into our Controlled Documentation systems.

Method validation
Method validation is a process that usually starts with an in-house single validation exercise which can then progress to validation at multiple sites and then to standardised publication.

We are happy to produce our own Validation Protocols, or work to formats provided by our client. After execution of the protocol results are provided as a final method validation report in line with the protocol, with the method details included or referenced. Typical test method validation parameters are based on ICH guidelines (for example robustness, linearity, limit of detection, limit of quantitation, accuracy, precision, and specificity) or as agreed with the client.

OUR VALIDATION METHODS INCLUDE:
HPLC (assay and impurities methods, cleaning verification methods)
Liquid injection chromatography (solvent identification and release test methods)
Headspace gas chromatography (residual solvent analysis)
Physical methods such as Malvern sympatec particle sizing, specific surface area by BET and XRPD
Trace and major elemental determination by ICP-OES and X-ray fluorescence and total organic carbon analysis
API raw material and chemical intermediate methods (Karl Fischer, titration, loss on drying, residue on evaporation)
Method verification
Method verification is used to demonstrate that a standardised published method can be run effectively in each laboratory.

The requirements for method verification are less stringent than for validation but the principle approach is the same. A formal Verification Protocol with defined acceptance criteria is produced and agreed with the client (the client always agrees and signs the protocol). The verification is then executed and reported in a Verification Report, with the method details included or referenced.

The extent of the verification will depend on the procedural and sample complexity but as a minimum the verification will require demonstration that the performance parameters (for example system suitability tests) specified in the method have been met with the matrices to which the method is being applied (typically analyte recovery assessment). For HPLC assay methods it is sometimes necessary to carry out a limited linearity assessment due to flow cell differences.

OUR VERIFICATION METHODS INCLUDE:
HPLC (assay and impurities methods, cleaning verification methods)
Liquid injection chromatography (solvent identification and release test methods)
Headspace gas chromatography (residual solvent analysis)
Physical methods such as Malvern sympatec particle sizing, specific surface area by BET and XRPD
Trace and major elemental determination by ICP-OES and X-ray fluorescence and total organic carbon analysis
API raw material and chemical intermediate methods (Karl Fischer, titration, loss on drying, residue on evaporation)

Analytical Development Analytical Method Development Analytical validation studies

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Physicochemical Testing

Price on request

We offer a wide range of GLP Physico-chemical services, including storage stabilities under various conditions depending on client’s needs

GLP

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Particle Analysis and Characterization

Price on request

Concept Life Sciences’ partnership with Malvern Panalytical combines advanced instrumentation with expert analytical services to accelerate pharmaceutical development. The partnership delivers the unique ability to develop and deploy accredited physicochemical analysis techniques and methods within the pharmaceutical and food industries, underpinned by Malvern Panalytical’s understanding of analytical instrumentation and Concept Life Sciences’ method development, validation and support expertise.

Our fleet of advanced instrumentation includes:

  • Morphologi4 (image, size and shape analysis, including Morphologically Directed Raman Spectroscopy)
  • Mastersizer 2000/3000 (Laser diffraction)
  • APS2000 (foreign particulate matter/particle counting USP <788>)
  • Malvern Panalytical Zetasizer Ultra (analysis of nanoparticles)

Morphologi4 Malvern Mastersizer 2000 Mastersizer 3000 Zetasizer Drug Discovery Pharmacology Particle Size Particle Size Characterization Nanoparticles API Show 10 more tags Show less

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ICH Stability Testing

Price on request

Our ICH stability storage services provide our customers with a holistic package from protocol to final report and with trended data analysis. Within our cGMP-certified pharmaceutical development laboratories we have qualified, mapped & monitored incubators supported by back-up emergency power, emergency call-out and contingency storage capacity over the following conditions, and in full compliance with ICH guidelines:

  • -80ºC, -20ºC and refrigerated, including temperature cycling for pMDIs
  • 25ºC / 60%RH
  • 30ºC / 65%RH
  • 40ºC / 75%RH

We routinely provide stability study services extending to a wide range of industry types including:

  • Human & Veterinary Pharmaceuticals (drug substance & finished products)
  • Medical Devices
  • Advanced Wound Management

For the pharmaceutical industry our services are used to determine the stability of drug substance materials from our Integrated Discovery & Development teams; from late lead optimisation and candidate selection through to formulations and materials used for pre-clinical and FIH trials. We also routinely run stability studies on launched commercial products and on GMP API batches used in clinical trials and pre-clinical toxicology studies. A related service requiring controlled storage of test samples is extractable and leachables testing, please follow this link for further details.

Time point analysis:

Our unrivalled breadth of analytical techniques and applications includes solid state / materials characterisation instrumentation, chromatographic analysis and standard compendial release test methods. Analytical methods undergo stage-appropriate verification, validation and transfer from non-GMP to full ICH validation, as required. For stability-indicating chromatographic methods we have significant expertise and experience in performing targeted forced degradation studies.

Furthermore, when unknown impurities form on storage that must be identified then our synthetic chemistry division are global leaders in the Identification, Isolation & Synthesis of impurities, including the provision of certified reference materials.

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Separation/Purification Services

Price on request
Request a quote for more information about this service.

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Solubility and Dissolution Testing

Price on request

Our primary goal in polymorph screening is typically to identify the most thermodynamically stable polymorph under expected ambient and processing conditions. Getting to that point often requires a structured screen, but tailored to the specific goals of the development team.

The solubility of the compound in each target solvent utilised in the stable polymorph screen is also assessed during this programme. This protocol is supported by the wide range of analytical equipment on site able to quickly characterise the differences between the identified forms (XRPD, FTIR, DSC, TGA, polarised light microscopy, DVS, Raman spectroscopy, Headspace GC and Karl Fischer). Further analytical techniques are then available to determine the solubility/bioavailability of the found forms like low volume dissolution.


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Particle Size Distribution

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Immuno-oncology Assays

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We have extensive in vitro immunology, pre-clinical immuno-oncology and specialist multiplex histology experience. Our suite of available immuno-oncology services and assays can be specifically tailored to your project:

  • Exhausted CD4+ T Cell assay 
  • Human PBMC & T Cell Activation assays
  • Human Mixed Lymphocyte Reactions
  • Human DC, Macrophage and Co-culture assays
  • T Cell Killing assay

macrophages T cell stimulation CD4+ T cells PBMC's Immuno-Oncology

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PBMC Isolation

Peripheral Blood Mononuclear Cell Isolation
Price on request

We take the time to understand your target pathway to offer the most appropriate assay for your stage of development e.g. screening for compound selection or detailed mechanism of action (MOA)/validation study.

PBMC assays are ideal if you require large scale analyses using simple immune stimuli. We can customise and design a PBMC study to meet your research needs e.g. TLR-stimulation for innate mononuclear cell activity or T cell receptor ligation for T cell function, accelerating your drug discovery pipeline.

PBMCs can be used in all areas of immunology, from autoimmunity to cancer, and in multiple assays. The data derived is informative for progressing to more advanced immunoassays (monocultures and/or co-cultures) designed to further interrogate the MOA of your compound

Immunology Cancer Autoimmune Diseases mechanism of action PBMC's Immunology Show 6 more tags Show less

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Immunoassays

Price on request

We can help you understand your target’s and/or compound’s mechanism of action to progress your drug discovery pipeline. We offer collaborative experimental design and can advise on the most suitable cell types, mono- or co-culture assays. By tailoring, customising and developing assays to suit your requirements, we can build a data package that is right for you.

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In vitro Immunogenicity Assays

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Neuroscience

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we offer a consultative approach to understand your MOA and to investigate your test compounds. We share expertise to help you understand your drug candidates, gathering robust data to drive confident decision making throughout your CNS drug discovery process.  Our team has the experience, know-how and specialist equipment to offer in vitro and ex vivo model systems combined with specialist multiplex histology readouts as well as ADME services, ensuring a comprehensive, customisable CNS program. Our suite of neuroscience services can be specifically tailored to your project: 

  • Primary CNS cell-based assays 
  • Ex vivo brain slice assays
  • Human iPSC CNS disease models
  • RNA and protein based multiplex histology services
  • Brain penetrant and receptor occupancy services

CNS/Neurology Neurodegeneration Neuroinflammation Neurodegenerative diseases Alzheimers Disease Parkinson's disease (PD) Multiple sclerosis (MS) Neuroscience Drug Mechanisms of Action Studies Ex Vivo assays in vivo MBP-induced Experimental Autoimmune Encephalomyelitis (EAE) iPSC Primary Cells Organotypic Brain Slices Custom Assays Show 16 more tags Show less

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RNAscope Assay

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Aquila the first accredited provider of ACD Bio’s RNAscope® technology in Europe. We can use RNAscope to help you with:

  • Pre-clinical assessment of efficacy and toxicity
  • Visualising the expression of target(s) across multiple tissues
  • Validating mechanisms of action of novel targets within disease models in tissue samples
  • Assessing tumour heterogeneity and the tumour microenvironment
  • Studying targets where there is limited availability of reliable antibodies.




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Multiplex Immunofluorescence

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We offer multiplex immunohistochemistry (IHC) and immunofluorescence (IF) assays to enable detection of multiple targets on one section. Our automated approach uses Leica robots to give you a consistent, reproducible and high-throughput service that can be adapted for multiple protocols and detection strategies.

Key advantages of using IF multiplex, include:

  • Identifying multiple targets in the same section
  • Up to six fluorescent endpoints + counterstain (7-plex)
  • Sensitive tyramides used for IF
  • Multiple antibodies from the same species
  • Conservation of precious tissue samples
  • Target validation and distribution data


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Multiplex Immunohistochemistry (mIHC)

Price on request

We offer multiplex immunohistochemistry (IHC) and immunofluorescence (IF) assays to enable detection of multiple targets on one section. Our automated approach uses Leica robots to give you a consistent, reproducible and high-throughput service that can be adapted for multiple protocols and detection strategies.

  • Colourimetric DAB/AP
  • Polymer detection systems
  • Streptavidin based
  • Labelled secondary antibodies


macrophages dendritic cell NK cell CD4+ T cells B cells

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Histopathology Consulting

Price on request

Our team has the experience, expertise and specialist equipment to deliver technically demanding projects. Our ethos is to work closely with you to understand your histology requirements, and to tailor services specifically to meet your needs for:

  • Histology
  • Human tissue samples
  • Multiplex IF/IHC
  • RNAscope
  • Image analysis
  • Clinical trial support

All our staff are GCP and/or GCLP trained and work to GCP for labs standards. A QA audit programme is in place, which includes study-based, process-based and annual facility inspections.

Located in the Edinburgh BioQuarter, a unique geographical location with easy access to multiple expert institutions, we can source local, ethically approved human tissue for most types of cancer. Each cohort of samples is reviewed by a Senior Academic Clinical Histopathologist who can respond to bespoke tissue requests.

Perkin Elmer Vectra Polaris Leica BOND RX Leica BOND-III Zeiss Axioscope 2 Olympus BX51 Immunofluorescence immunohistochemistry RNAscope Multiplexed fluorometric immunoassay Multiplexed mRNA analysis Whole slide scanning Image analysis Microarray ELISA MSD ELISPOT FACS in situ hybridization (ISH) FFPE tissue Fresh Tissue Frozen Tissue Oncology Immuno-Oncology CNS/Neurology Neurodegeneration Show 25 more tags Show less

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Pharmacology

Price on request

Our expertise in drug discovery spans multiple target classes including GPCR, ion channels, nuclear hormones, kinases and other enzymes. Our pharmacologists have many years’ experience working in cardiovascular, respiratory, CNS, urogenital and immune inflammation therapeutic areas. We can set up integrated screening cascades to expedite lead discovery and optimisation. We can also validate cell- based and non cell-based assays for primary pharmacology screening and mechanism of action.

Our teams have a strong background in assay development and optimisation of target based and phenotypic screens on electrophysiology platforms. We can access human derived IPSc stem cells for the development of translationally relevant assays.

We believe it is this integration of pharmacology, ADMET and DMPK that is so important for the development of PK/PD relationships.


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Toxicology

Price on request

Concept Life Sciences has an extensive track record in the design, performance and interpretation of pre-clinical investigative, mechanistic and exploratory/discovery toxicology programmes.

These programmes are typically intended to identify the toxicological mode of action (MOA)/adverse outcome pathway (AOP) affected by the compound in question.  We establish custom in vitro and in vivo models to answer specific toxicological questions.

We also offer exploratory and discovery toxicology services to characterise potential (for example on-target) or observed toxicity issues.  Through an understanding of mechanistic toxicology at the early research stage, we can generate information that informs molecule design, candidate selection and translational risk assessment.

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Endocrine Disruptor Screening

Price on request

We can assess the potential for chemicals to disrupt the endocrine system through in vitro assays.  Should the potential for endocrine disruption be observed in a regulatory toxicology study or in vitro assay, we will design an investigative experimental programme to assess the effect of the compound on the endocrine system and determine the potential risk to humans.

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Residual Impurity Analysis

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Residual Solvent Analysis

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Chemical Reference Standards

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Metabolite Generation

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Metabolite Quantification

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Trace Metal Analysis

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A skilled approach is essential to elemental analysis and trace metals testing. Concept Life Sciences has one of the largest ICP-MS and OES fleets operating to cGMP in the UK, together with the experience and skills to handle drug substance, excipients and drug products in accordance with ICH Q3D, USP <232> / <233> and Ph Eur Pharmacopoeias.

We have significant capacity enabling us to start your project when required and our highly qualified analytical scientists have many years of experience in sample preparation for low level elemental analysis.

Our sample preparation capability includes microwave digestion and experience with a wide range of digestion media including organic solvents, hydrogen peroxide and mineral acids, including Hydrofluoric Acid.

A wide range of complementary elemental techniques and services are also available at Concept Life Sciences for elemental analysis:

  • Inductively Coupled Plasma (6 x ICP-OES, 7 x ICP-MS).
  • Anionic & Cationic Ion Chromatography.
  • Flame Photometry.
  • Cold Vapour Atomic Fluorescence Spectroscopy.
  • Total Carbon Analysis (and speciation into inorganic, organic and elemental forms).
  • Scanning Electron Microscopy with EDX Detection.
  • Extractables & Leachables Testing Services
  • Pharmaceutical Salt Screening
  • Total N and S by oxidation/IR


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Metabolite Identification

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5-Batch Analysis

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Acrylamide Analysis in Food

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With the increased concern about the levels of Acrylamide in food, Concept Life Sciences has the capability to offer a UKAS accredited analytical service to test a variety of food products for the presence of Acrylamide. Using state-of-the-art liquid chromatography techniques, we are able to provide Acrylamide testing with reporting levels down to 10μg/kg, ensuring conformance against the regulation benchmark levels. Acrylamide is a chemical substance formed in starchy food products during high temperature cooking (over 120°C) in the process of frying, roasting or baking. It is formed by a reaction between amino acids and sugars in a chemical process known as the Maillard Reaction. It is found in products such as roasted potatoes and root vegetables, fried potatoes, potato crisps, bread, toast, biscuits, cakes, coffee and some cereals. Acrylamide is not deliberately added to foods during growing or production, but is a natural by-product of the cooking process, and has always been present in our food. Trials have shown that Acrylamide in the diet causes cancer in animals. Whilst evidence from human trials on the effects of acrylamide in the diet is not conclusive, it is believed that Acrylamide in food has the potential to cause cancer, and it is therefore important to monitor and reduce exposure. In 2015 the European Food Safety Authority (FSA) adopted an opinion on Acrylamide in food. Based on animal studies, the FSA has confirmed previous evaluations that Acrylamide in food potentially increases the risk of developing cancer for consumers in all age groups.


On 20th November 2017 the EU Commission released Regulation EU 2017/2158 to establishing mitigation measures and benchmark levels for the reduction of the presence of Acrylamide in food. The regulation sets out various criteria along with benchmark levels for various food materials and will be applied from 11th April 2018. If you would like more information on Acrylamide testing, or to discuss your specific requirements with one of our team, please contact us on 01954 782791 directly.


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Product Stability Testing

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Our ICH stability storage services provide our customers with a holistic package from protocol to final report and with trended data analysis. Within our cGMP-certified pharmaceutical development laboratories we have qualified, mapped & monitored incubators supported by back-up emergency power, emergency call-out and contingency storage capacity over the following conditions, and in full compliance with ICH guidelines:

  • -80ºC, -20ºC and refrigerated, including temperature cycling for pMDIs
  • 25ºC / 60%RH
  • 30ºC / 65%RH
  • 40ºC / 75%RH

We routinely provide stability study services extending to a wide range of industry types including:

  • Human & Veterinary Pharmaceuticals (drug substance & finished products) 
  • Medical Devices
  • Advanced Wound Management

For the pharmaceutical industry our services are used to determine the stability of drug substance materials from our Integrated Discovery & Development teams; from late lead optimisation and candidate selection through to formulations and materials used for pre-clinical and FIH trials. We also routinely run stability studies on launched commercial products and on GMP API batches used in clinical trials and pre-clinical toxicology studies. A related service requiring controlled storage of test samples is extractable and leachables testing, please follow this link for further details.

Time point analysis:  Our unrivalled breadth of analytical techniques and applications includes solid state / materials characterisation instrumentation, chromatographic analysis and standard compendial release test methods. Analytical methods undergo stage-appropriate verification, validation and transfer from non-GMP to full ICH validation, as required. For stability-indicating chromatographic methods we have significant expertise and experience in performing targeted forced degradation studies. 

Furthermore, when unknown impurities form on storage that must be identified then our synthetic chemistry division are global leaders in the Identification, Isolation & Synthesis of impurities, including the provision of certified reference materials.


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Chemical Stability Testing

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Nutritional Analysis

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With customer concerns ever increasing and legislation always changing, it is critical for food manufactures to perform analytical nutritional analysis on products and to clearly display this nutritional information on packaging. Concept Life Sciences offer a comprehensive range of nutritional analysis services from its facilities to support food manufacturers and suppliers with compliance to food labelling legislation, compliance with retailer specifications, due diligence and quality control, new product development and surveillance studies.

Our nutritional analysis services include:


Group 2

  • Ash 
  • Moisture 
  • Protein 
  • Sodium 
  • Sugar 
  • Carbohydrates (by difference) 
  • Energy 
  • Fat 
  • Dietary Fibre 
  • Fatty acid profile including trans  

 Group 1 

  • Other Analyses 

In our UKAS laboratory, we have nutritional experts who provide a trusted and highly respected service and our highly qualified staff can ensure the accuracy of the analyses conducted. Concept Life Sciences’ nutritional analysis laboratory is equipped with state-of-the-art analytical instrumentation including ion chromatography, gas chromatography, nuclear magnetic resonance (NMR) as well as traditional wet chemistry technique, enabling fast, efficient and accurate generation of nutritional labelling data. All testing is carried out in accordance with the internationally recognised ISO/IEC 17025:2005 Standard with widespread accreditation of the major tests. Alongside our Nutritional analysis services, we offer services to assess your product labelling and ensure that every aspect, including layout and language, complies with legislation, including the EU’s Food Information to Consumers regulation. 


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Food Allergen Testing and Control

Price on request

The EU law (Regulation No.1855) lists 14 allergens that need to be identified and declared if they are used as ingredients in a food product. We can offer a comprehensive range of allergen testing using ELISA and PCR methods. We can provide a service for all 14 main allergens :

  • Cereals containing gluten
  • Crustaceans, for example prawns, crabs, lobster and crayfish
  • Eggs
  • Fish
  • Peanuts
  • Soybeans
  • Milk
  • Nuts, such as almonds, hazelnuts, walnuts, pecan nuts, Brazil nuts, pistachio, cashew and macadamia (Queensland) nuts
  • Celery (and celeriac)
  • Mustard
  • Sesame
  • Sulphur dioxide, which is a preservative found in some dried fruit
  • Lupin
  • Molluscs, for example clams, mussels, whelks, oysters, snails and squid.


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Food Safety Testing

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Microbiology

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Our food microbiology team has both laboratory and industry knowledge, enabling us to understand the industry demands for food testing hygiene and food safety.

Our food microbiology laboratory has been designed to accommodate high sample numbers throughout with attention to detail, efficiency and safety. The facility has a one-way sample flow which ensures elimination of the potential for cross contamination during sample processing.

Open 7 days a week and offering a sample collection service, we work in ‘real time’ with the food industry.

We have extensive storage capacity at both ambient and chilled conditions to store samples for shelf life work.

The laboratory has extensive ISO/IEC 17025:2005 accreditation in addition to being a TLAS and M&S approved microbiology service provider.


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