Almac Invests in New Commercial API Manufacturing
In order to satisfy increasing demands, Almac are expanding their manufacturing capacity to over 30m3 at its European Headquarters in Craigavon, UK. The upgraded facility will include reactor vessels with state of the art clean room product isolation and drying equipment to allow Highly Potent API manufacture up to 600kg batch size.
With currently 6 API and advanced chiral intermediates in Phase III clinical development, Almac has steadily increased its market penetration in late phase clinical development, leveraging its API and Drug Product Integrated offering. This major expansion will allow Almac to continue its commitment to deliver high quality API at competitive prices to its customers. Denis Geffroy, VP Business Development stated: “We are delighted with the progress made over the past 2 years to increase our presence in late phase clinical development. This capacity increase will allow a smooth transition from late phase clinical development to full commercialisation. Scale was becoming a limiting factor for some of our client projects and this new capacity is a strong commitment to offer project continuity. It opens up a new chapter in Almac’s API manufacturing capability”
It is anticipated that the facility will be built, commissioned and validated within the next 2 years. In the meantime, Almac will continue progressing late stage manufacturing projects within their existing facilities and with a number of key supplier relationships. Dr Rick Dyer, VP Operations added, ““This expansion allows us to build on our expertise in early phase clinical development projects and further continue our success within late phase projects so clients need not transfer some of our well developed processes elsewhere due to lack of scale. This investment will further place Almac as the supplier of choice to satisfy all client requirements from preclinical phase to full commercialisation.”
Almac’s advantage of hosting all facilities on one site have led to the successful technology transfer of small molecule and peptide projects from lab development to large scale manufacture.
Additionally, the increase in chiral late stage projects is attributed to Almac’s selectAZymeTM technology platform. Almac is applying their enzyme technology to customer processes resulting in shorter and more stream lined syntheses. The customer sees immediate benefits due to lower chemical and manufacturing costs as well as applying green credentials to their process which is in line with the need to minimise environmental factors. Initially launched in 2009 with the sale of six enzyme kits, Almac’s biocatalysis capabilities have expanded to the supply of 100s of kgs of both chiral intermediates and APIs. Dr Tom Moody, Head of Biocatalysis notes “Biocatalysis is now recognised as a premier solution for solving complex chemistry problems due to its rapid implementation, economic benefits and “green” reputation. It is the technology of choice for chiral chemistry within Almac.”
Using selectAZymeTM technology as opposed to conventional routes to APIs has significantly improved yields, productivity and timelines for multi-step syntheses. Denis Geffroy further commented, “We believe that our biocatalysis offering is unique within the marketplace and when coupled with our skills and expertise in synthetic chemistry, it opens immediate benefits to our customer projects. Our growth in this area, coupled with our planned facility expansion will give our clients maximum opportunity for success in their product development projects.”
For further information, Almac will be exhibiting at the forthcoming CPhI (Booth 41C18) and AAPS (Booth 2837) conferences.
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