APIs
Contract manufacturers look to API manufacture for business
We present a round-up of new developments in API synthesis and manufacturing technologies, and show how these are leading to new business opportunities for CMOs serving the pharmaceutical industry.
ue to the identification of new high- potency drug candidates, custom chemical manufacturers are seeing increased demand for high-potency API manufacture. Several major expansions capacity investments and expansions have been completed over the past two years.
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Almac: new commercial API manufacturing investment
Almac is expanding its manufacturing capacity to over 30 cubic metres at its European Headquarters in Craigavon, UK. The company says this is in order to satisfy increasing demand for its services. The upgraded facility will include reactor vessels with clean room product isolation and drying equipment to allow highly potent API manufacture up to 600 kg batch size.
Almac has been increasing its market penetration in late-phase clinical development and now has six APIs in Phase 3 clinical development. The company says scale was becoming a limiting factor for some of its client projects and that the new capacity will
allow it to offer project continuity, adding to its API manufacturing capability.
It is expected that the facility will be built, commissioned and validated within the next two years. In the meantime, Almac will continue progressing late-stage manufacturing projects within the company’s existing facilities and with a number of manufacturing partners. Having all facilities on one site has already 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 selectAZyme technology platform. Launched in 2009 with the sale of six enzyme kits, Almac’s biocatalysis capabilities have expanded to the supply of hundreds of kilograms of both chiral intermediates and APIs.
Cambridge Major completes regulatory pre-approval inspection
Cambridge Major Laboratories Europe (CMLE), a supplier of chemistry services supporting drug substance development, has completed its first regulatory pre-approval inspection (PAI) for a commercial API. The audit of the company’s Weert, The Netherlands facilities was conducted at the end of August. At the same time, the general certificate to manufacture drug substances intended for clinical trial application was renewed for another three years. Cambridge Major Laboratories produces pharmaceutical intermediates and APIs from early preclinical development to commercial manufacture. The company operates FDA- inspected facilities in the USA and Europe, and is organised in five Centers of Excellence: Process Chemistry; GMP Manufacturing; Solid State Chemistry; Analytical Services; and Quality/Regulatory Compliance.
SafeBridge Certification for new SAFC facility
A 4,000-litre glass-lined reactor for the manufacture of high potency APIs at SAFC’s Verona, Wisconsin, USA facility.
26 sp2 November/December 2011
SAFC has been granted SafeBridge Certification for its commercial-scale high-potency API (HPAPI) facility in Verona,
Wisconsin, USA. The SafeBridge programme assessment focuses on four primary areas: management; hazard identification and evaluation; hazard controls; and communication, education and training. Constructed at a cost of $30 million and officially opened in April 2010, the Verona site was built specifically to support pharmaceutical manufacturers with their Phase 3 and commercial HPAPI needs. The facility is designed to increase efficiencies and safe handling in high-potency production and to adhere to Category IV standards, the highest guideline for HPAPI handling and containment. The SafeBridge assessment, which also included a re-certification of SAFC’s nearby Madison, Wisconsin high- potency facility, took place in September this year. The process included review of health and safety programmes, containment equipment testing results, and appraisal of material handling and GMP production areas. Over the past three years, SAFC has seen a continual increase in the number of projects for HPAPIs and other high-potency pharmaceutical services, including late-stage projects that will need commercial-scale manufacturing. The construction of the Verona facility was in response to this demand: the facility houses commercial-scale reactors capable of producing HPAPI batch sizes up to 4,000 litres and in addition has quality control laboratories, warehouse and office space, plus space for expansion. While oncology is currently the main driver for HPAPI development, SAFC has manufactured HPAPIs for indications in other areas, including low-dose Vitamin D analogues for autoimmune and cardiovascular diseases. The company says this range of indications may continue to grow as additional potent compounds are identified and developed in the future.
Solvias and RohnerChem partnership
Switzerland-based companies Solvias and RohnerChem have formed a preferred but non-exclusive partnership that completes the services chain from route scouting to
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