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Reading Scientific Services Ltd. (RSSL)

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Reading, GB

About Reading Scientific Services Ltd. (RSSL)

Reading Scientific Services Ltd is the complete partner for your analytical, consultancy and training requirements as we work towards our mission of 'Science Enhancing Lives'. Supported by extensive Quality systems and working to GMP standards, our multidisciplinary teams and technical experts don't just provide test results, but go much further to provide practical solutions, rapid outcomes, expert interpretation and sound advice.


Our wide-ranging chemical, physical, biopharmaceutical, impurity and microbiological services are all about supporting you through the drug development and manufacturing process, ensuring your products integrity from raw material to market.


But don't just take our word for it; amongst other accolades, in 2019 we were named Business of the Year (Thames Valley Business Magazine Awards) and Best Contract Research Organisation (OBN Awards).

Certifications & Qualifications

FDA Inspected GMP ISO 17025

Our Services (116)


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Gas Chromatography (GC)

Gas Chromatography
Price on request

GC capability: Agilent (6890 / 7890) and Perkin Elmer GC systems (Clarus 680), with inlet capabilities including direct injection, headspace (Turbomatrix 110) and cool on column. Detectors: FID, TCD, NCD and ECD.  


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GC-MS

Gas Chromatography Coupled Mass Spectrometry
Price on request

GC-MS: capabilities for E&L and impurity investigations using the following instrumentation:


Agilent 7890A GC-MS (EI and CI source capability): Agilent GC-MS single quad, with Electron ionisation and Chemical Ionisation source. Autosampler, and headspace analysis (Perkin Elmer headspace trap) compatibility. This instrument is used for E&L studies, investigations and routine GC-MS analysis. Split board, so it can analyse FID and MS at same time if required.


Agilent 7890B GC-MS: Agilent GC-MS single quad, with Electron ionisation. This instrument is used for E&L studies, investigations and routine GC-MS analysis.  




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Free Amino Acid Analysis

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Package and Container Testing

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HPLC-MS

High Performance Liquid Chromatography Coupled Mass Spectrometry
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The following equipment is used for Extractable&Leachable (E&L) studies, Analysis of Nitrosamines and Impurity Investigation and Elucidations: 

- Agilent 6545 Q-ToF: An accurate MS connected to a UPLC. This is a key instrument for Impurity Investigations, where the combination of accuracy of the mass ions, the separation capability of the UPLC (compared to traditional HPLC), and the sensitivity of the instrument (positive and negative) allow us to investigate most pharmaceutical-based species. The fragmentation (MS/MS) is vital for the structural elucidation during the investigation. Additionally, we have both electrospray ionisation (ESI) and atmospheric chemical ionisation (APCI) ion sources, which helps extend the range of chemical species to be analysed.

- Agilent 6495 TQ LC-MS: in conjunction with the APCI meets very low thresholds which is required for nitrosamine analysis. This instrument is designed for Quantitative Analysis (method development and validation) such as nitrosamines.

- Thermo QExactive Orbitrap LC-MS: a highly capable MS with a very high mass accuracy connected to a UHPLC. It has the ability to analyse in both positive and negative polarity together, making it the best instrument for Extractable&Leachable (E&L) studies.  

Agilent 6545 Q-ToF Agilent 6495 TQ LC-MS Thermo QExactive Orbitrap LC-MS Extractables and Leachables Impurity Identification Nitrosamine Quantitative LC-MS Show 7 more tags Show less

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Ion Exchange Chromatography

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Antibody Purification

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Antibody Characterization

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Protein PEGylation

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Deamidation Measurement

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PCR

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Mycoplasma Testing

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Reversed-Phase Chromatography (RPC)

Reversed phase chromatography
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Isoelectric Focusing (IEF)

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PAGE

Polyacrylamide Gel Electrophoresis
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Particle Analysis and Characterization

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Forced Degradation Studies

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Protein Aggregation Analysis

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Quantitative Western Blot Analysis

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ELISA

Enzyme-linked immunosorbent assay
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Immunochemical characterisation of proteins using ELISA alone or in combination with Western Blot


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Disulfide Bond Mapping by LC/MS/MS

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Peptide Mapping

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Molecular Weight Determination

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Biopharmaceutical Characterization

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Comprehensive range of analysis to ICH Q6B and EMA Guidelines:


Comparability

Method development & validation

Molecular weight or size

Protein or peptide sequencing

Post Translational Modification (PTM)

Disulfide-mapping

Forced degradation studies

Immunochemical properties by ELISA or Western Blot

Glycosylation analysis

Amino acid composition

Aggregation studies

Bioassay for potency

Bioassay for ELISA

Troubleshooting & investigations


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Protein Biophysical Characterization

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Protein Quantification

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DNA Extraction and Purification

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Host Cell Protein (HCP) Detection

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Assay development for host cell proteins


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Cleaning Validation Services

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Sterility Testing

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New Sterility Service.

Fast 16 day turnaround available and a fantastic first year offer.

Product Validations available now!


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Batch Release Testing

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We provide a comprehensive pharmaceutical and biopharma DS and DP release testing service to support you in ensuring the identity, purity, stability and quality of your products. Please contact us for details.

Wet Chemistry Analysis HPLC Analytical GC NMR USP EP JP BP Show 8 more tags Show less

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ICH Stability Testing

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The long term stability of drug products (and other healthcare related products) is key to its quality, efficacy, safety and commercialisation. The stability of a product can be assessed in many ways e.g. physical stability (e.g. tablet crumbling, precipitation, viscosity), chemical (e.g. API degradation) or microbiological.

It is therefore vital to carry out stability studies that conform to ICH requirements and that challenge your prototypes and products in a range of environments.

Stability Storage

Our pharmaceutical stability services include a range of monitored temperature, humidity, and light stability storage cabinets which comply with ICH Guidelines, covering requirements for climatic zones I to IV.

Our stability storage conditions:
-80°C and -20°C
5°C
25°C/60%RH
30°C/65%RH
30°C/75%RH and 40°C/75%RH

We can store Schedule I to V controlled drugs and low temperature storage is available. In addition, we are able to set up non-standard temperature/humidity conditions upon request.

Our storage facilities are secure, fully validated and maintained and are 21CFR compliant monitored 24 hours a day, with a dedicated out of hours response team on call in case of emergency.

Whether you require storage only, or in combination with in-house analytical testing, we can tailor our stability service to meet your needs.

Stability Testing

We have a vast range of analytical techniques under the general banners of chemical, microbiological and physical testing that can be used to assess the stability of your product and its packaging in accordance with GMP requirements. We have experience in the development of pharmaceutical stability indicating methods, including photostability and other stress conditions. From protocol preparation to the issue of final reports, we offer comprehensive project management, plus advice and support.


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Impurity Analysis

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Identification, isolation and purification of process related impurities can be critical to the development and manufacture of pharmaceutical products. Our technical specialist’s expertise in chromatographic and spectroscopic techniques can support with the isolation and identification of impurities from pharmaceutical products or active pharmaceutical ingredients (APIs).  Preparative scale isolation is carried out using techniques including preparative liquid chromatography HPLC. Advanced spectroscopic techniques can then be used to identify the impurities of interest, these include nuclear magnetic resonance spectroscopy (NMR; 400Mhz)), mass spectrometry (MS; see LC-MS section for more details) and Fourier transform infra-red spectroscopy (FTIR). Once the impurity has been identified, we can also offer further scale-up for the isolation of larger quantities of impurities for use as reference materials.  We are able to scale-up customer specific methods or develop reproducible extraction and purification methods for your products and API’s. 

Services include: 

o Impurity isolation

o Impurity characterization 

o Sample purification 

o Method development 


Techniques available: 

o Preparative High Performance Liquid Chromatography (Water Autopurification LC prep system)

o Chromatography Techniques: Reverse Phase (RP-HPLC), Ion Exchange (IC), Normal Phase (NP-HPLC) and HILIC  o Liquid Chromatography Mass Spectrometry (LC-MS; see in the section above for more details) 

o Solid Phase Extraction (SPE) 

o Fourier Transform Infra-Red Spectroscopy (FTIR) 

o Nuclear Magnetic Resonance Spectroscopy (NMR; 400Mhz) 

o Ultra-violet/Vis Spectroscopy (UV/Vis)    

HPLC Q Exactive Orbitrap LC-MS/MS system NMR GC-MS

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Protein Identification

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RSSL offers a rapid services to help you identify unknown proteins in you biopharma products.

Q Exactive Orbitrap LC-MS/MS system UPLC Oncology

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Microbiology Testing

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We help you ensure the microbiological quality of your pharmaceutical, medical device and healthcare products, demonstrate that you are meeting regulatory requirements and prove that you have good hygienic production procedures.

You can rely on our MHRA-inspected microbiology laboratory to test your product’s microbiological quality and safety and provide method development and validation services. We also partner with you in instances where pharmaceutical microbiology testing, consultancy and troubleshooting are required, for continuous improvement of your processes and procedures or in response to a specific incident.

We perform microbial limits testing for specific pathogens, bacteria, yeast and moulds at all stages of the production cycle, from raw materials, finished products and medical devices.

In addition to this, we also offer preservative efficacy testing, kinetic turbidimetric LAL (Limulus Amebocyte Lysate) endotoxin analysis, analysis of water, challenge testing, and environmental monitoring to fully support in ensuring the microbiological quality and of your products.

Microbiological services include:

  • Microbial limits to EP, USP and JP
  • Quantitative endotoxin analysis
  • Preservative efficacy testing
  • Environmental monitoring
  • The European Suspension Test (eg EN1276, EN13697)
  • Water testing
  • Method development and validation

Typical product types tested:

  • Oral
  • Topical
  • Parenteral
  • Ophthalmic
  • Medical devices
  • Raw materials

Bioburden Test Method Validation TAMC TYMC Microbial Limits (USP <61> <62>) EP Bacterial Endotoxin Testing Show 6 more tags Show less

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Extractable and Leachable Testing

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Extractable and leachable (E&L) testing and analysis is critical in maintaining the quality of your drug product or combination drug delivery device. As part of the drug development and route to market, it is vital to identify both the substance and source of any leachable as they may significantly alter the identity, strength or quality of the drug, risking patient safety. There are a number of analyses which must be performed in order to comply with regulatory guidelines, and we can assist throughout with extractable and leachable testing:


In the first instance, an extractable profile needs to be determined for all materials which will come into contact with your drug product. Once it has been determined whether any extractables in this profile are present as leachable within the product, you also need support in quantifying amounts and establishing the biological risk based on exposure. Analytical support can be  during all stages of this process. E&L testing has been performed on a wide variety of containers, closures and medical combination drug delivery devices using state-of-the-art equipment and expertise.

The following instrumentation is used for the E&L studies:


LC-MS   

Thermo QExactive Oribtrap LC-MS: A highly capable mass spectrometer with a very high mass accuracy connected to a UHPLC . It also has the ability to analysis in both positive and negative polarity together, making it the best instrument for Extractables and Leachables Study.


GC-MS

Agilent 7890A and B GC-MS (EI and CI source capability): Agilent GC-MS single quad, with Electron ionisation and Chemical Ionisation source. Autosampler, and headspace analysis (Perkin Elmer headspace trap) compatibility. Split board, so can analyse FID and MS at same time if required.


ICP-MS

Agilent 8800x ICP-QQQ

LC-MS/MS GC-MS ICP-MS

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Analytical Method Development

Price on request

Choose us as a partner for method development and validation, and you gain access to an experienced, specialist multi-disciplinary team. For both APIs and drug products, we have the capabilities to support you through the entire drug lifecycle.

Our cross-laboratory, multi-disciplinary approach, combined with exemplary customer focus and communication, makes us an ideal partner for method development and validation activities. You can trust us to manage projects effectively and achieve key milestones.

We understand that as companies focus on achieving ever shorter timescales of drug to market, a tailored and pragmatic approach is vital in both Active Pharmaceutical Ingredient (API), Drug Product (DP) and medical device method development and validation activities. Many years of experience working with a diverse client base and multitude of different dosage forms means we can guide and advise you on developing robust, fit-for purpose methods appropriate for the specific phase of the development life-cycle. Our specialists offer a wealth of knowledge and advice on areas ranging from sample preparation and extraction techniques to regulatory aspects.

Following successful method development, we can perform method validation in line with an approved protocol at a level that reflects the ICH requirements for the particular project type and stage of API/DP development.

Techniques available include:

  • UltraViolet-Visible (UV/VIS)
  • High-Performance Liquid Chromatography (HPLC) with UV. Diode Array (DAD), or Fluorescence Detection (FLD)
  • Gas Chromatography with Flame Ionisation Detection (GC-FID)
  • Gas Chromatography-Mass Spectrometry (GC-MS)
  • Ion Chromatography with Conductivity Detection (IC-CD)
  • High-Performance Anion Exchange Chromatography with Pulsed Amperometric Detection (HPAEC-PAD)
  • Liquid Chromatography-Mass Spectrometry (LC-MS)
  • Atomic Absorption Spectroscopy (AAS)
  • Inductively Coupled Plasma Mass Spectrometry (ICP-MS)
  • Inductively Coupled Plasma Optical Emission Spectrometry (ICP-OES)
  • Laser Diffraction (Mastersizer 2000 and 3000)

Method parameters include (based on ICH guidelines):

  • Specificity
  • Limits of detection and quantification
  • Linearity
  • Accuracy
  • Precision
  • Solution stability

HPLC GC-FID NMR

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Chemical Contaminant Analysis

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We specialise in resolving chemical contaminant issues for the pharmaceutical industry, using in-house specialist expertise combined with a range of analytical techniques and state-of-the-art GMP-qualified equipment.

Our expertise in contaminant identification is well known, with our team’s expert understanding of the variety of sampling, extraction and analytical methods available enabling us to provide you with the most thorough and effective analysis possible, whatever the analyte. Our multi-disciplinary approach enables us to support you in incidents of accidental or deliberate contamination, counterfeit and adulteration, and manufacturing or processing failures.

We understand the business impact of chemical contamination, and the importance of a rapid response to ensure consumer safety and protect your brand. Work with us for analysis and investigative consultancy and you gain an expert partner in resolving contamination issues. As well as identifying the contaminant, we support you in finding the root cause (whether accidental or malicious), understanding the safety and quality implications of an incident, and taking appropriate corrective action. Our analytical techniques include ICP-MS analysis as well as other spectroscopy methods.

Pharmaceutical contamination is often an emergency situation, where speed in resolution is imperative. You may wish to consider membership of our 24/7 Emergency Response Service (ERS) for guaranteed technical support whenever you need it.

Microscopes X-Ray fluoresence SEM HPLC GC NMR Hach HIAC Show 7 more tags Show less

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Shelf Life Testing

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We perform real-time stability and shelf-life testing of ingredients and finished products to support you with food product development, claims substantiation testing and troubleshooting.

Assessing stability over shelf-life is a crucial stage in new food product development and reformulation. You need to ensure that your product maintains its characteristic flavour, texture, structural and chemical features throughout the length of its stated shelf-life.

We provide stability and shelf-life testing for raw ingredients and finished food products under a range of conditions, ensuring that you have full understanding of product changes and behaviour over time. We measure changes over shelf life for components such as sweeteners, preservatives, colours, fats, oils, and vitamins, looking at texture, rheology and more. We can also support you with food analysis and testing (including fats and oils testing) to ensure any claim you make about your product can be substantiated over its entire shelf-life for food product development and reformation.

For fats and oils testing and for finished products containing them, we provide an accelerated oxidative stability testing service using Rancimat and Oxipres equipment. Accelerated testing allows you to narrow down potential formulations to the most promising for real-time testing, and to assess the impact of different processing conditions on stability. Your food product development timescale is therefore shortened with our lipid analysis and lipid testing capability, leaving a quicker route to market. Our NPD consultancy has the knowledge to support you with your new product development process.

ICH Stability In Use Stability Method Transfer Method Validation

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Product Quality Control

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Product Testing Services

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Microbiology

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Protein Characterization

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Protein Characterization Services


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Glycosylation Analysis

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Glycosylation Analysis Services


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Microbiology Assays

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Professional Development Consulting

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Spectroscopy

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Spectroscopy Services


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Spectroscopy Consulting

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Chromatography

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Chromatography Services


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Separation/Purification Services

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Purification Services


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Chromatography Consulting

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Particle Size Distribution

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Wet Chemical Analysis

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Drug Formulation Evaluation

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Protein Services

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Protein Services


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Biochemistry & Molecular Biology

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Biochemistry & Molecular Biology Services


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Glycosylation Analysis Consulting

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Assay Development

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Chemical Stability Testing

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Microscopy

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Microscopy Services


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Imaging & Spectroscopy

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Imaging & Spectroscopy Services


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Microscopy Consulting

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Proteomics

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Proteomics Services


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Moisture Analysis

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Chemical Analysis

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Powder Characterization

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Sulfated Ash Test

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Microbial Identification and Strain Typing

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Business Operations and Logistics Support

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Business Operations and Logistics Support Services


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Microbiology Quality Control

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Granulation/Compaction/Agglomeration

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Auditing and Compliance Support

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Chemistry, Manufacturing and Controls (CMC)

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Analytical Method Validation

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Karl Fischer Titration

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Solubility and Dissolution Testing

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Residual Impurity Analysis

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Compendial Testing

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Drug-Excipient Compatibility Studies

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Raw Material Testing

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Accelerated Stability Testing

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Residue On Ignition (ROI) Testing

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Assay Development Consulting

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Biopharmaceutical Consulting

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Drug Development

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Drug Development Services


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Drug Discovery & Development

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Drug Discovery & Development Services


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Drug Product Characterization

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Laboratory Equipment and Facility Management Services

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Microbial Limit Testing

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Particulate Analysis

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Product Appearance Test

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Leak Testing

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Bioproduct Safety Testing

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USP Water Testing

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USP Testing

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USP Testing Services


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Quality Assurance

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Materials Science

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Material Testing Services

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Pharmaceutical Product Testing

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Endotoxin Testing

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Dose Delivery Testing

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Accelerated Aging

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Discrete Chemical Analysis

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Bioburden Testing

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Residual Solvent Analysis

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Unknown Material Identification

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Aerosol Testing

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Protein Sequencing

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Protein Sequencing Services


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Post-Translational Modification Analysis

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Protein Digestion

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Electron Microscopy

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Hydrolyzed Amino Acid Analysis

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NMR

Nuclear magnetic resonance spectroscopy
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As part of impurity elucidation projects, a 400Mhz NMR is currently used. In the near future, a Bruker 600Mhz will be added to the 400Mhz service. 


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Calorimetry

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Biopharmaceutical Development

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Protein Formulation

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GJ

Gaynor Johnston

Commercial Lead Biopharma & Personalised Medicine
TP

Thorsten Platz

Pharmaceutical Impurities Commercial Lead
BR

Bryony Richards

Core Commercial Lead - Life Sciences
AR

Annette Russell

Sterile Manufacture Commercial Lead
SS

Stacey Scuffell

Sales Excellence Lead
CW

Christopher Winch

Head of Life Sciences

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