SafeBridge® Certification for Almac Sciences’ cytotoxics plant

Pharma custom services innovators Almac Sciences – a division of the Almac Group – has announced SafeBridge® Certification in the safe handling of potent pharmaceutical compounds for its cytotoxic and potent compound manufacturing operations. Certification covers facilities, containment equipment, procedures and personnel training at the division’s Craigavon, Northern Ireland facility. SafeBridge Consultants, Inc. (SafeBridge®) is recognised for its high level safety, health and environment consultancy support to the pharma, biotech and chemical industries – with the potent compound Certification programme as a noted specialty.

Certification at Craigavon specifically embraces competency in the safe handling of materials in pre-clinical, clinical and commercial scale operations for the production of cytotoxic and potent APIs as well as radiolabelled syntheses. Included are the facilities for cytotoxic manufacture where barrier isolators (glove box technology) contained within dedicated suites are used for the safe handling of these compounds at the 80,000 sq. ft. production complex. These state-of–the-art facilities were expanded in 2003.

Development, kilo-lab and cGMP manufacturing suites have been designed to operate at 0.1μg/m3 OEL for cytotoxic compounds enabling manufacture of cytotoxic products at commercial scale. For potent compound manufacture, the cGMP manufacturing plant, (also operated at 0.1μg/m3 OEL) allows production at ~ ten fold higher levels.

SafeBridge® Certification is a respected benchmark in highly demanding pharma HPS operations that are focused on a handful of international players, including Almac Sciences. Commenting on the certification, Almac Sciences’ Commercial Operations VP Dr. David Moody said:

“This is a further enhancement of our package of supply chain solutions in all-scale production of cytotoxics and potent compounds. SafeBridge® Certification is the gold standard in this rapidly-growing sector of pharma services and sends a highly positive message to the customer and prospective customer communities”.

Dr Rosaleen McGuckin, VP Business Development, added:

“We are delighted to have such an important, independent certification of our facilities and philosophy for the supply of cytotoxic products to our customers.”

John Farris, CIH, President and CEO of SafeBridge® was part of the Certification and evaluation team. He noted:

“Almac Sciences have met our criteria for Certification through the application of engineering controls for the containment of powder handling operations, construction of modern contained facilities in the GMP Labs for kilo scale operations and implementing a comprehensive system of Standard Operating Procedures – including potent compound safety elements”.

Beyond cytotoxics and potents, Almac Sciences’ Craigavon facility has a wide range of connected capabilities in pharma contract services. They include R&D, custom manufacturing, analytical services, peptides, protein and oligo synthesis, chirals and radiolabelling.

SafeBridge’s® potent compound safety Certification programme verifies performance with set criteria in management, evaluation, containment, control and communication elements of potent compound production operations. Elements of the programme include on-site assessment of production plant and equipment, training, toxicology, occupational hygiene and environmental control.

assessment of production plant and equipment, training, toxicology, occupational hygiene and environmental control.

Almac Sciences recently announced collaboration for cytotoxic and potent fill-and-finish services with the Center for Pharmaceutical Science and Technology – CPST, at the US University of Kentucky.

Focused on IV formulation and sterile fill for clinical trial applications, the agreement with CPST involves facilities at its new, US $17m. Coldstream research campus, near Lexington.

Other Almac Sciences highlights since mid-2006 have included the launch of Carbon 14 radiolabelling services, and commissioning of a £500,000 package of new assets at its Northern Ireland and Scottish sites for enhanced multi-kilo GMP production of peptides.

Notes for Editors:

• • With capabilities across contract R&D, custom manufacturing and analytical services, Almac Sciences has been supporting drug discovery, development and commercialisation since 1992.Almac Sciences operates from a £25m., 80,000 sq. ft. HQ and laboratory complex in Craigavon, Northern Ireland, with a production and R&D center near Edinburgh, Scotland. The business has over 200 employees, including 120 scientists.
  • The business is part of the Almac Group, which comprises five closely integrated divisions offering a broad range of services from R&D, diagnostic/genomic services, API manufacture, formulation development, clinical trial supply and technology (IVRS/EDC), to commercial-scale manufacture. Almac provides services to over 600 companies including all the world leaders in the pharmaceutical and biotech sectors.
  • Almac announced the re-branding of its five business divisions under the Almac brand name in mid-June 2006. In total, the Group employs 2,000 people in Northern Ireland, Scotland, England and the USA. See almacgroup.com
  • Through its three companies, SafeBridge® provides professional scientific and engineering consulting services and analytical support to clients across the US and internationally, including the UK, Ireland, Continental Europe and Canada. SafeBridge® services also cover environmental health and safety; toxicology; industrial hygiene; analytical lab; safety and loss control and environmental services.
  • Staff include occupational and environmental toxicologists, industrial hygienists and safety and environmental professionals. SafeBridge® has key offices in Mountain View California, New York and Liverpool, UK. See www.safebridge.com

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