Almac Group ltd

Craigavon,  COUNTY ARMAGH 
United Kingdom
http://www.almacgroup.com
  • Booth: 1101

Almac Group is an established, leading contract development and manufacturing organisation providing an extensive range of integrated services to over 600 pharmaceutical and biotech companies globally. Its Sciences Business Unit offers services including API development & manufacture, radiolabelling, biocatalysis solutions, peptides & protein technology, pre-formulation, solid state and analytical services. Its Pharma Services Business Unit offers early & late phase pharmaceutical development, pharmaceutical product launch & distribution, commercial drug product manufacture, commercial packaging, serialisation & commercial storage & distribution. The privately owned, global organisation has grown organically over 45 years now employing in excess of 4,500 highly skilled personnel and has a strong reputation for innovation, quality and exceptional customer service. The Group is headquartered in Craigavon, Northern Ireland with additional operations based throughout Europe, US and Asia.


 Press Releases

  • Craigavon, N.I., 12 December 2016 – Almac Group, the global contract development and manufacturing organisation has announced the appointment of Professor Tom Moody to the position of VP Technology Development and Commercialisation within Almac Sciences, effective from 1 December 2016.

    Tom joined Almac in October 2001, moved into management in 2008 and has held the position of Senior Manager for the last 4 years operating in his role as Head of Biocatalysis and Isotope Chemistry. Over this time he has led the development of Almac Sciences’ Biocatalysis Technology platform which has seen rapid growth and has multiple applications across a range of project scales and industry sectors.

    In the last year he has played an integral role in the integration of Arran Chemical Company Ltd into Almac Sciences and ensured smooth transfer of Biocatalysis manufacturing projects from Craigavon to the Arran site in Athlone, Ireland.

    In his new role, Tom will be responsible for the development and application of platform technologies within both the Sciences and Arran businesses, in addition to supporting and directing commercialisation of new technology. He will have direct operational responsibility for the Biocatalysis and Isotope Chemistry businesses and the R&D function within Arran.

    Tom will report directly to Dr Stephen Barr, President & MD, Almac Sciences who congratulated him on his promotion:

    “Tom’s considerable expertise and experience within biocatalysis and chemical synthesis has been crucial in developing the Sciences, and more recently, Arran businesses.  In addition, his ability to form incredibly strong relationships with our clients has been critical to the growth and success of these particular service offerings.  I am delighted to announce Tom’s promotion to VP and wish him every success in his new role.”

    Tom holds a Masters in Business with Distinction in Business Strategy, a PhD in Organic Chemistry and a Bachelor of Science (BSc) in Chemistry (First Class Hons).

    About Almac Group

    ‘Partnering to Advance Human Health’

    The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.

    The international company is a privately owned organisation that has organically grown over 40 years and now employs in excess of 4,500 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

    https://www.almacgroup.com


 Products

  • API Development and Manufacture
    Almac's technical expertise and extensive facilities enable us to offer integrated API contract manufacturing solutions through all stages of the drug development lifecycle....

  • 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 potent compounds 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.

  • Biocatalysis Solutions
    Almac supports a world-leading biocatalysis technology platform to secure the supply of biocatalysts for non-GMP and GMP manufacturing projects alike....

  • Biocatalysis Solutions:  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.
  • Peptide and Protein Technology
    Almac have supplied peptides to the research community and for clinical trials for over 10 years and developed specialised technical expertise which allows us to manufacture peptides with a wide range of complexity in dedicated non-GMP and GMP facilities....

  • 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 .

  • 14C Radiolabelling
    We are MHRA certified for 14C IMP and GMP compliance and we are fully equipped to deliver an industry-leading, cost-effective radiolabelling service....

  • 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.

  • Preformulation
    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....

  • 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.

  • Solid State Services and Support
    We can develop and validate processes and methods to control and deliver the desired form during scale-up, troubleshoot existing problems, and generate intellectual property....

  • 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.

    Particle/ powder characterisation and control is also important at early phase, as it keeps formulation development costs to a minimum.

    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. With experienced chemists, analysts, and formulators within the team, you’ll be sure to benefit form a holistic overview of early phase development.

  • Pharmaceutical Development
    Addressing the increasing pressure for pharmaceutical companies to bring clinical candidates through their pipeline faster and with greater efficiency, we provide expert pharmaceutical development solutions....

  • Addressing the increasing pressure for pharmaceutical companies to bring clinical candidates through their pipeline faster and with greater efficiency, we provide expert pharmaceutical development solutions.

    Operating from state-of-the-art, custom designed facilities, our scientists can develop your clinical candidate into an optimum formulation, and manufacture oral dose products for all stages of clinical trials.

    From developing a fit-for-purpose formulation for First-in-Human trials, to developing a more robust formulation and scaling up for late phase trials and ultimately commercialisation, our integrated pharmaceutical development solutions are customised to meet your needs.

  • Pharmaceutical Development - Early Phase
    For early phase First-in-Human (FIH) supplies, we offer a range of solutions...

  • Almac’s experienced formulation scientists can develop a range of oral dose formulations for early stage clinical trials.

    With both non-GMP and GMP facilities, flexible and efficient solutions are provided to develop a fit-for-purpose formulation for your early phase clinical trial.

  • Pharmaceutical Development - Late Phase
    Specialising in solid oral dosage forms, Almac has the technical experience and knowledge to develop robust formulations and manufacturing processes....

  • Specialising in solid oral dosage forms, Almac has the technical experience and knowledge to develop robust formulations and manufacturing processes.

    We have assisted many of our clients in the development of both immediate and modified release formulations, for their late stage clinical trials, registration batch manufacturing and commercial launches. Our expertise covers the development of the following dosage forms:

    • Immediate and modified release capsules
    • Immediate and modified release tablets
    • Fixed dose combinations
    • Powder / granule filled sachets