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Almac Sciences Ltd.

6 Orders Completed
Craigavon, GB

About Almac Sciences Ltd.

Divison of: Almac Group

The Almac Group is a fully integrated contract development and manufacturing organisation that provides an extensive range of drug development services to the pharmaceutical and biotech sectors.

Almac provides chemical development services for all stages of drug development, be that synthesis of non-GMP... Show more »

The Almac Group is a fully integrated contract development and manufacturing organisation that provides an extensive range of drug development services to the pharmaceutical and biotech sectors.

Almac provides chemical development services for all stages of drug development, be that synthesis of non-GMP material for early research, cGMP supply for clinical development and onwards to full process validation for provison commerical drug subtance. Expertise includes small molecules (including highly potent compounds), synthetic peptides and conjugates.

Key technologies such as radiolabelling, biocatlaysis, physical sciences and site specific conjugation are deployed to reach development milestones.

From stand-alone to fully integrated services, Almac's highly skilled scientists work closely with our clients to ensure high quality, on time and in full delivery of outsourced projects.

Our analytical team has a proven track record in rapid method transfer, method development and method validation.

Working closely with our clients, we deliver robust, efficient, stability-indicating and fit-for-purpose analytical methods. We fully understand and comply with the analytical support demanded by regulatory authorities at each stage of the drug product lifecycle.

Our unique blend of experience, expertise, and focus enables us to deliver, reliable, information-rich methods to meet your exact requirements. Typical analytical techniques include, but are not limited to:

  • HPLC and U(H)PLC
  • Ion Chromotography
  • Q-NMR
  • Dissolution (USP apparatus 1 and 2)
  • LC-MS / GC-MS
  • Particle size by laser diffraction
  • GC
  • Volumetric/ Coulometric KF
  • XRPD
  • Potentiometric Titration
  • UV Spectrophotometry
  • Fluoresence Spectrophotometry
  • ICP-MS

Utilising the extensive library of in-house methods, statistical exploration tools, and emerging analytical technologies, such as UPLC™ and Empower 2, we can reduce your method development, validation time and associated costs while generating accurate and reliable data.

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Certifications & Qualifications

GMP

Our Services (29)


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Analytical Method Validation

Price on request

Developing and validating 300 drug substances and drug product methods each year
The Almac analytical team have a comprehensive working knowledge of method validation requirements that can be tailored to different phases of clinical development. To ensure methods meet regulatory requirements we follow relevant ICH guidelines such... Show more »

Developing and validating 300 drug substances and drug product methods each year
The Almac analytical team have a comprehensive working knowledge of method validation requirements that can be tailored to different phases of clinical development. To ensure methods meet regulatory requirements we follow relevant ICH guidelines such as ICH Q2(R1) or compendial guidance in combination with client-specific protocols. Comprehensive reports are provided upon completion.

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Analytical Method Development

Price on request

Developing and validating 300 drug substances and drug product methods each year

Our highly skilled method development scientists have acquired years of experience, working across many types of products, methods and analytical technologies to ensure a successful outcome. Utilising laboratories equipped with sophisticated... Show more »

Developing and validating 300 drug substances and drug product methods each year

Our highly skilled method development scientists have acquired years of experience, working across many types of products, methods and analytical technologies to ensure a successful outcome. Utilising laboratories equipped with sophisticated analytical instrumentation, we can develop analytical methods suitable for all your needs.

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Enzyme Immobilization

Price on request

Our enzyme immobilisation service involves:
Recycling and repeated reuse of the biocatalyst improves the commercial viability of enzyme-mediated processes.
Recovery and reuse of costly enzymes, facile handling of the enzyme and easier product recovery and enzyme separation.
Improved enzyme performance, and increased pH and temperature stability.

Our enzyme immobilisation service involves:
Recycling and repeated reuse of the biocatalyst improves the commercial viability of enzyme-mediated processes.
Recovery and reuse of costly enzymes, facile handling of the enzyme and easier product recovery and enzyme separation.
Improved enzyme performance, and increased pH and temperature stability.

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Metabolite Generation

Price on request

Metabolite Synthesis

Cloned Human P450
Cloned Microbial P450
Extensive microbial collection

Metabolite Isolation/Structure ID

Analytical and prep LC
LC/MS
High-field NMR

Almac’s scale-up ability allows us to rapidly take ‘hits’ from conception to gram delivery as and when our customers require the products.

Metabolite Synthesis

Cloned Human P450
Cloned Microbial P450
Extensive microbial collection

Metabolite Isolation/Structure ID

Analytical and prep LC
LC/MS
High-field NMR

Almac’s scale-up ability allows us to rapidly take ‘hits’ from conception to gram delivery as and when our customers require the products.

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Stable Isotope Analysis

Price on request

With our extensive experience in the synthesis and analysis of stable and 14C isotope labelled compounds – from drug discovery through to launch - we can label any compound at any stage, including small molecules, peptides and larger bio molecules.

With our extensive experience in the synthesis and analysis of stable and 14C isotope labelled compounds – from drug discovery through to launch - we can label any compound at any stage, including small molecules, peptides and larger bio molecules.

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Biopharmaceutical Process Development

Price on request

To improve process efficiency, our chemists can perform process optimisation and intensification with the goal of increasing yields, reducing raw materials and waste, and simplifying process operability. Once the process starts to become established, the focus changes so that knowledge and understanding become the primary objectives, ensuring the process is robust.

To improve process efficiency, our chemists can perform process optimisation and intensification with the goal of increasing yields, reducing raw materials and waste, and simplifying process operability. Once the process starts to become established, the focus changes so that knowledge and understanding become the primary objectives, ensuring the process is robust.

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Biopharmaceutical Manufacturing

Price on request

We have an established reputation for developing processes through every stage of clinical development. Our extensive experience lies in taking processes from inception through to process validation, both in small molecule chemistry and peptides.

We have an established reputation for developing processes through every stage of clinical development. Our extensive experience lies in taking processes from inception through to process validation, both in small molecule chemistry and peptides.

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Drug Development

Price on request

Almac’s strength in API development and manufacture is proven by being the partner of choice for many pharma and biotech companies seeking integrated drug development solutions from molecule to market.

Our technical expertise and extensive facilities enable us to offer integrated API contract manufacturing solutions through all... Show more »

Almac’s strength in API development and manufacture is proven by being the partner of choice for many pharma and biotech companies seeking integrated drug development solutions from molecule to market.

Our technical expertise and extensive facilities enable us to offer integrated API contract manufacturing solutions through all stages of the drug development lifecycle. We are fully supported by dedicated analytical and regulatory teams.

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Pharmaceutical Manufacturing

Price on request

Almac’s strength in API development and manufacture is proven by being the partner of choice for many pharma and biotech companies seeking integrated drug development solutions from molecule to market.

Our technical expertise and extensive facilities enable us to offer integrated API contract manufacturing solutions through all... Show more »

Almac’s strength in API development and manufacture is proven by being the partner of choice for many pharma and biotech companies seeking integrated drug development solutions from molecule to market.

Our technical expertise and extensive facilities enable us to offer integrated API contract manufacturing solutions through all stages of the drug development lifecycle. We are fully supported by dedicated analytical and regulatory teams.

In addition, we offer numerous support capabilities, including: rapid implementation of chromatography for purification, containment equipment for and micronisation to control particle size. Our dynamic team successfully address many complex project challenges, and implementing our on-site biocatalysis technology expertise is one example of our responsive solutions.

Project management is critical for the effective execution and delivery of our customers’ complex projects. Our project managers are experienced scientists, working with clients to anticipate and respond to project priorities.

Almac has an excellent regulatory history with regular inspections by all appropriate regulatory bodies (FDA, MHRA) and our clients.

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Peptide Synthesis

Price on request

Our custom peptide synthesis offering is based on decades of trading and hundreds of working years gaining valuable experience in the field. During this time, we have produced in excess of 9,000 peptides on a custom synthesis basis and we have become experts in the production of long peptides and complex peptide structures such as... Show more »

Our custom peptide synthesis offering is based on decades of trading and hundreds of working years gaining valuable experience in the field. During this time, we have produced in excess of 9,000 peptides on a custom synthesis basis and we have become experts in the production of long peptides and complex peptide structures such as folded proteins and peptide conjugates.

We have a proven track record in high quality supply, while providing excellent customer service through the balance of technical expertise and project management.

We have a proven track record in high quality supply, while providing excellent customer service through the balance of technical expertise and project management.

Custom Synthesis Capabilities

Peptides are produced by Fmoc / tBu solid phase synthesis and can be manufactured on the scale of mgs to 10s of grams. Most projects are completed in an efficient high throughput basis using parallel synthesis equipment, with a short lead time of less than 4 weeks.

Our entire range of standard peptide modifications are available per your request, including labelling with biotin, fluorescein or other fluorophores, or the formation of disulfide bridges. Unnatural building blocks, such as phosphorylated, acylated or methylated amino acids, are routinely incorporated into the peptide sequence. Additionally, we have a license from Life TechnologiesTM that enables us to incorporate the highly desirable AlexaFluor® dyes into synthetic peptides.

Technically Challenging Peptides

  • Long Peptides
  • Folded Proteins
  • Cyclised peptides
  • Specialist Catalogue Peptides

We provide complex peptides as catalogue products for basic biological research.

We have our well established catalogue of chemokine products for use in wide-ranging research. More recently we have established a range of products for epigenetics research such as histones and ubiquitylated peptides.

These products are highly specialist, and many are unique to Almac, offering physiologically relevant reagents for research.

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Biocatalyst Development

Price on request

Biocatalysts are essential tools in chemical synthesis, particularly in the synthesis of pharmaceutical and fine chemical targets. As highly selective catalysts, they offer a direct and simple way to synthesise complex achiral and chiral compounds. The application of biocatalysts in the pharmaceutical and fine chemical industries... Show more »

Biocatalysts are essential tools in chemical synthesis, particularly in the synthesis of pharmaceutical and fine chemical targets. As highly selective catalysts, they offer a direct and simple way to synthesise complex achiral and chiral compounds. The application of biocatalysts in the pharmaceutical and fine chemical industries continues to grow as it moves from the domain of specialised technology to mainstream methodology. This movement has been facilitated by the increasing commercial ‘off-the-shelf’ availability of biocatalysts. Almac has heavily invested in this area to secure the supply of selectAZymeTM biocatalysts for clients’ non-GMP and GMP manufacturing projects.

Our Biocatalysis Group

Consisting of computational, molecular and micro biologists, enzymologists, organic chemists and analysts, the group has demonstrated expertise in gene identification, expression, enzyme evolution, fermentation, enzyme production and biotransformation scale-up. Expertise ranges from enzyme production to the synthesis of complex chiral APIs from mg-tonne scale.

Our team is closely linked to the process chemistry and manufacturing chemistry groups, where enzyme discovery and development is integrated with screening and route definition. Each member of the team brings expertise to complex processes procedures and can rapidly implement an enzymatic process to significantly improve the yield and timelines of a multi-step synthesis.

selectAZymeTM

SelectAZme

This exclusive technology platform consists of a number of recombinant enzyme panels that can be used in chemical processing across multiple functional group interchanges.

With this unique selectAZymeTM platform, we can offer you a range of enzymes suitable for carrying out a wide variety of chemical reactions. We have the expertise to guide your biosynthesis from conception to scale-up.

We can deliver the following:

  • FTE or FFS contracts
  • Screening of our biocatalyst toolbox with customer substrates – comprising of biocatalyst selection and route demonstration
  • Biocatalytic route invention and process development
  • Enzyme supply on a £ / Kg basis
  • Enzyme development and evolution
  • Tech transfer and ongoing support through all the manufacturing steps, including the training of personnel, if required
  • Supply of chiral intermediates
  • Microbial screening and molecular biology for the development of novel biocatalysts
  • Fermentation development and scale-up
  • Metabolite synthesis
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Radiolabeling/Radiosynthesis

Price on request

QC and analytical support, including method development and validation, method transfer and radiolabelling stability studies

With our extensive experience in the synthesis and analysis of stable and 14C isotope labelled compounds – from drug discovery through to launch. We can label any compound at any stage, including small... Show more »

QC and analytical support, including method development and validation, method transfer and radiolabelling stability studies

With our extensive experience in the synthesis and analysis of stable and 14C isotope labelled compounds – from drug discovery through to launch. We can label any compound at any stage, including small molecules, peptides, and antibody drug conjugates.

14C is the radioisotope of choice in preclinical and clinical ADME studies. 14C avoids the challenges encountered with tritium labelling, including label exchange and the loss of label due to radioactive decay.

2H, 13C and 15N stable labels are routinely used to prepare stable labelled versions of APIs. Multiple labels are typically incorporated to ensure complete mass resolution from the unlabelled API.

Isotopic labelling imposes many synthetic challenges beyond those found in normal chemical synthesis. When the isotope is radioactive, this becomes even more demanding. That’s why we offer advice on the most appropriate label position for your molecule, including feasibility and metabolic stability.

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Chemical Synthesis

Price on request

gram | kilogram | tonne

Capabilities:
• Route design and implementation.
• Essential process development to support first time scale up for toxicology and First-in-Human batches.
• Thorough process development for late phase clinical batches, establishing process understanding and optimization.
• DoE and Quality by Design.
• Process robustness.
• Process validation.

gram | kilogram | tonne

Capabilities:
• Route design and implementation.
• Essential process development to support first time scale up for toxicology and First-in-Human batches.
• Thorough process development for late phase clinical batches, establishing process understanding and optimization.
• DoE and Quality by Design.
• Process robustness.
• Process validation.

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gram kilogram ton

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Drug Formulation Evaluation

Price on request

salt, cocrystal and polymorph

Almac’s Physical Sciences groups’ comprehensive range of services and expertise will help strengthen the success of your product.

Identifying and consistently producing a drug in its optimal physical form is vital to any successful drug development programme. It also avoids the need for... Show more »

salt, cocrystal and polymorph

Almac’s Physical Sciences groups’ comprehensive range of services and expertise will help strengthen the success of your product.

Identifying and consistently producing a drug in its optimal physical form is vital to any successful drug development programme. It also avoids the need for bridging toxicological or pharmacokinetic studies or the need to implement expensive form control strategies at short notice.

Through the creation of synergy between solid-state chemistry and formulation development, our experienced scientists have the ability to add great value to your pre-clinical project, while decreasing timelines.

Our investigations are driven by science, not robotics with highly trained chemists and analysts directing every study. We have delivered screening, troubleshooting and analysis solutions for over 100 virtual, biotech and large Pharma clients, thus contributing to the success of many drug development programmes.

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Synthetic Chemistry

Price on request

Our combination of scientific skills, technologies and facilities enables us to provide you with innovative chemistry solutions from milligram to multi-tonne scale.

Route design
Biocatalysis technology
Building blocks
Milligrams to multi-tonne synthesis
Synthesis of potent compounds
Synthesis and formulation of labelled compounds (Pre-Clinical and Clinical)

Our combination of scientific skills, technologies and facilities enables us to provide you with innovative chemistry solutions from milligram to multi-tonne scale.

Route design
Biocatalysis technology
Building blocks
Milligrams to multi-tonne synthesis
Synthesis of potent compounds
Synthesis and formulation of labelled compounds (Pre-Clinical and Clinical)

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Biopharmaceutical Characterization

Price on request

Almac have a number of tools at their disposal for this service:

High resolution mass spec protein mapping
Amino acid analysis according to USP 1052
N- and C- terminal sequence analysis
De novo sequencing
Sulfhydryl group and disulfide bond analysis
Carbohydrate structure analysis

Almac have a number of tools at their disposal for this service:

High resolution mass spec protein mapping
Amino acid analysis according to USP 1052
N- and C- terminal sequence analysis
De novo sequencing
Sulfhydryl group and disulfide bond analysis
Carbohydrate structure analysis
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Solid Form Screening

Price on request

Our Physical Sciences group has a considerable breadth of expertise in form screening and selection, so they can skillfully guide you to make the right decisions at the right time.

Enabling Salt Screen
Polymorph Screening
Salt and Cocrystal Screening
Amorphous Solids

Our Physical Sciences group has a considerable breadth of expertise in form screening and selection, so they can skillfully guide you to make the right decisions at the right time.

Enabling Salt Screen
Polymorph Screening
Salt and Cocrystal Screening
Amorphous Solids

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Salt Screening

Price on request

The selection of an appropriate salt provides an opportunity to modify the API’s physicochemical properties and resultant biological characteristics. However, the salt form selected will influence a range of other properties. It should also be noted that screening for developable salt forms could strengthen the intellectual... Show more »

The selection of an appropriate salt provides an opportunity to modify the API’s physicochemical properties and resultant biological characteristics. However, the salt form selected will influence a range of other properties. It should also be noted that screening for developable salt forms could strengthen the intellectual property of the API. A salt or cocrystal can also enable you to go over the next hurdle in the pharmaceutical drug development process, whether this is to move onto the initial toxicity studies or to go into clinical drug development.

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Polymorphism Screening

Price on request

Polymorph screening is designed to reduce the risks of drug development by finding the most stable form of the API and to define the form for clinical development and GMP manufacture. Our screening services are directed by highly trained chemists and analysts performing a scientific investigation tailored to your API properties,... Show more »

Polymorph screening is designed to reduce the risks of drug development by finding the most stable form of the API and to define the form for clinical development and GMP manufacture. Our screening services are directed by highly trained chemists and analysts performing a scientific investigation tailored to your API properties, development phase and budget, rather than generic protocols using robotics.

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Peptide Manufacturing

Price on request

Almac’s peptide and protein technology offering is a key component within our suite of services. We offer a complete range of peptide and protein services from catalogue products through to GMP manufacture from early phase to commercial launch. We have a proven track record in high quality supply, whilst providing excellent... Show more »

Almac’s peptide and protein technology offering is a key component within our suite of services. We offer a complete range of peptide and protein services from catalogue products through to GMP manufacture from early phase to commercial launch. We have a proven track record in high quality supply, whilst providing excellent customer service through the balance of technical expertise and project management within our MHRA audited facilities.

As specialists in the manufacture of complex and high quality peptides, we continually make significant technological advances to support your research and development programmes and routinely produce peptides in excess of 100 amino acids in length.

We are a reliable partner for GMP peptide manufacture across the drug development lifecycle, and have an established reputation for developing fit-for-purpose processes that will ensure the success of your drug development programme.

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Drug Preformulation

Price on request

Preformulation is the stage of development during which the physicochemical properties of the drug substance are characterised and established. Knowledge of the relevant physiochemical and biopharmaceutical properties determines the appropriate formulation and delivery method for Pre-Clinical and Phase 1 studies.

Through the... Show more »

Preformulation is the stage of development during which the physicochemical properties of the drug substance are characterised and established. Knowledge of the relevant physiochemical and biopharmaceutical properties determines the appropriate formulation and delivery method for Pre-Clinical and Phase 1 studies.

Through the creation of synergy between solid state chemistry and formulation development, our experienced scientists have the ability to add great value to your pre-clinical project, while decreasing timelines.

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Analytical Chemistry Services

Price on request

Almac employs over 150 highly skilled analysts working in GMP / GLP environments across UK, Europe and US with significant experience in the analysis of both small and large molecules. Our state-of-the-art labs support drug substance (API) and drug product (finished product) analytics across all phases of clinical development and... Show more »

Almac employs over 150 highly skilled analysts working in GMP / GLP environments across UK, Europe and US with significant experience in the analysis of both small and large molecules. Our state-of-the-art labs support drug substance (API) and drug product (finished product) analytics across all phases of clinical development and into commercial release.

All of our facilities are fully certified by the appropriate authorities (FDA, MHRA, INAB, HPRA). Our Irish laboratory, formerly BioClin Research Laboratories, is Ireland’s only GLP accredited lab.

We offer a full suite of analytical testing for a range of different product types including small molecules, peptides, biologics, conjugates, potent and controlled substances. Our vast pool of scientific knowledge can help to overcome the analytical challenges that typically arise during drug development.

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Solubility and Dissolution Testing

Price on request

Providing full support for finished product testing on tablets, capsules, injectables, oral medications and medical devices

Assay and impurities by HPLC/UPLC
Dissolution testing
Elemental impurities (USP<232> and <233>)
Moisture content
Physical testing (XRPD, NMR, Mass Spectroscopy, TGA, DSC, DVS, PSD, Microscopy)
Stability studies

Providing full support for finished product testing on tablets, capsules, injectables, oral medications and medical devices

Assay and impurities by HPLC/UPLC
Dissolution testing
Elemental impurities (USP<232> and <233>)
Moisture content
Physical testing (XRPD, NMR, Mass Spectroscopy, TGA, DSC, DVS, PSD, Microscopy)
Stability studies
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Co-Crystallization

Price on request

The selection of an appropriate salt provides an opportunity to modify the API’s physicochemical properties and resultant biological characteristics. However, the salt form selected will influence a range of other properties. It should also be noted that screening for developable salt forms could strengthen the intellectual... Show more »

The selection of an appropriate salt provides an opportunity to modify the API’s physicochemical properties and resultant biological characteristics. However, the salt form selected will influence a range of other properties. It should also be noted that screening for developable salt forms could strengthen the intellectual property of the API. A salt or cocrystal can also enable you to go over the next hurdle in the pharmaceutical drug development process, whether this is to move onto the initial toxicity studies or to go into clinical drug development.

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Peptide Libraries

Price on request

Peptides are produced by Fmoc / tBu solid phase synthesis and can be manufactured on the scale of mgs to 10s of grams. Most projects are completed in an efficient high throughput basis using parallel synthesis equipment, with a short lead time of less than 4 weeks.

Our entire range of standard peptide modifications are... Show more »

Peptides are produced by Fmoc / tBu solid phase synthesis and can be manufactured on the scale of mgs to 10s of grams. Most projects are completed in an efficient high throughput basis using parallel synthesis equipment, with a short lead time of less than 4 weeks.

Our entire range of standard peptide modifications are available per your request, including labelling with biotin, fluorescein or other fluorophores, or the formation of disulfide bridges. Unnatural building blocks, such as phosphorylated, acylated or methylated amino acids, are routinely incorporated into the peptide sequence. Additionally, we have a license from Life TechnologiesTM that enables us to incorporate the highly desirable AlexaFluor® dyes into synthetic peptides.

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Process and Scale-Up Chemistry

Price on request

We have significant experience in the first time scale-up of APIs. Starting with the medicinal chemistry route, our knowledgeable chemists can quickly identify the most pressing parts of the chemistry to develop.

The thermal safety of each process is assessed in-house by the DSC and ARSST and the heat of reaction data is... Show more »

We have significant experience in the first time scale-up of APIs. Starting with the medicinal chemistry route, our knowledgeable chemists can quickly identify the most pressing parts of the chemistry to develop.

The thermal safety of each process is assessed in-house by the DSC and ARSST and the heat of reaction data is measured by calorimetry. Purity control is assured by a combination of reaction progress control and the development of an effective and scalable purification strategy.

Our chemists work closely with our development analysts and production teams to ensure that controls are appropriately embedded into the process IPCs, intermediate specifications, and processing instructions. The salt form and polymorph landscape are explored within our physical sciences teams and drive the development of the API isolation process, and particle size is controlled through our micronisation suite.

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Particle Size Distribution

Price on request

We are experts in solid state chemistry. Our highly skilled scientists have undertaken thousands of studies that range from routine analysis to challenging characterisation under GMP studies.
Our particle size distribution service covers sieving, laser diffraction, image analysis....

We are experts in solid state chemistry. Our highly skilled scientists have undertaken thousands of studies that range from routine analysis to challenging characterisation under GMP studies.
Our particle size distribution service covers sieving, laser diffraction, image analysis....

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Mass Spectrometry

Price on request

Almac has the largest commercial cGMP and only GLP certified mass spec laboratory in Ireland

Robust and rapid LC-MS bioanalysis services are essential to pre-clinical and clinical programs, providing critical pharmacokinetic data to facilitate decision making at key stages of product development.

Our scientists are highly... Show more »

Almac has the largest commercial cGMP and only GLP certified mass spec laboratory in Ireland

Robust and rapid LC-MS bioanalysis services are essential to pre-clinical and clinical programs, providing critical pharmacokinetic data to facilitate decision making at key stages of product development.

Our scientists are highly experienced in the development of high quality assays using state-of-the-art LC-MS/MS technology – Applied Biosystems API 3000/4000 instrumentation which incorporates the automated reporting of data. This specialist Analyst software is compliant with FDA 21 CFR Part 11.

We excel in the development and validation of routine and non-routine methods in a very wide range of matrices ( i.e. muscle, kidney liver, fat, bone, bone marrow, synovial fluid, cardiac tissue, plasma, serum, whole blood, urine and faeces) and to apply these methods in a GLP and GCP compliant environment.

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Spectroscopy

Price on request

A state-of-the-art laboratory with a comprehensive range of fully GMP spectroscopic equipment

With a wide range of sophisticated MS and MNR instruments, Almac provides method development and validation of methods for identification of unknowns, bioanalysis, genotoxic impurities, elemental impurities and other requirements.... Show more »

A state-of-the-art laboratory with a comprehensive range of fully GMP spectroscopic equipment

With a wide range of sophisticated MS and MNR instruments, Almac provides method development and validation of methods for identification of unknowns, bioanalysis, genotoxic impurities, elemental impurities and other requirements. Almac’s specialist team has over 10 years’ experience in solving clients’ problems.

Elemental impurity analysis (ICP-MS) can be carried out in accordance with USP<232> / <233> and ICH Q3D in addition to Atomic Absorption Spectroscopy for specific pharmacopoeial methods.

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