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Almac Sciences Ltd.

Craigavon, GB

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... 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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Almac Sciences Ltd. has not listed any services.

Spray Drying
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Compound Synthesis
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Drug Product Manufacturing
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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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Biocatalyst Development
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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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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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Radioligand Synthesis/Radiolabeling
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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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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Chemical Engineering and Processing
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Chemistry and Materials
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Synthetic Chemistry
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Formulation & Manufacturing
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Radiochemistry
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Manufacturing
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2017-05-31 14:28:40 -0700

Net Promoter Score of 8 received for Drug Product Manufacturing.

Additional Ratings: satisfaction with deliverable: 9, satisfaction with timeliness: 8.

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