Contract API Manufacturing: The Year in Review - Pharmaceutical Technology

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PharmTech Europe

Contract API Manufacturing: The Year in Review
Expansion activity was limited as fine-chemical producers and CMOs of API and intermediates grapple with changing industry fundamentals.

Pharmaceutical Technology
pp. 36-40

Sigma-Aldrich's custom manufacturing and services business unit, SAFC, recently completed an assessment by SafeBridge Consultants and has been granted SafeBridge certification for its commercial-scale high-potency API facility in Verona, Wisconsin. Constructed at a cost of $30 million and officially opened in April 2010, the Verona site was built specifically to support manufacturing for Phase III and commercial scales up to Category IV compounds. The SafeBridge assessment also included a successful recertification of SAFC's nearby Madison, Wisconsin, high-potency facility.

Also in 2010, SAFC completed an expansion of its Jerusalem, Israel facility, which increased SAFC's contract manufacturing capabilities in large-molecule recombinant proteins and small-molecule APIs through fermentation, including high-potent APIs and secondary metabolites. The expansion focused on niche fermentation of APIs and bulk drugs, secondary metabolites, cytotoxins, and large-molecule proteins.

In October 2011, Saltigo reported that it will build new production capacities for potent APIs at its facility in Redmond, Washington. The company will expand its production to produce and handle Category III substances. Capacity up to the kilogram range will become available at the beginning of 2012.

Aescia recently invested in a new high-containment facility in Queenborough, United Kingdom. Separately, the company also purchased three manufacturing sites in Germany and Italy from the biopharmaceutical company UCB as announced in late 2010. Aesica acquired sites in Monheim and Zwickau, Germany, as well as UCB's Pianezza, Italy site.

In September 2011, Alphora completed the expansion of a cytotoxics R&D laboratory as part of an ongoing $4-million capital program for 2011. The 2011 capital program also includes other additions to R&D, GMP operations, analytical services and staffing. The new laboratory is designed to handle high-potency APIs and Class IV compounds. Other parts of the capital plan include the construction of a fourth cGMP kilo laboratory, a 10,000-ft2 GMP warehouse, and a new enterprise resource planning system, all of which are expected to be completed in the fourth quarter of this year. Expansion of a second pilot plant is planned for 2012.

Lonza is investing CHF 24 million ($26.2 million) to expand cytotoxic manufacturing capabilities at its fine-chemicals facilities in Visp, Switzerland. The investment will add multikilogram-scale cytotoxic capacity for clinical and commercial production. Lonza currently operates high potency GMP laboratory suites on a gram scale. The expansion is expected to be completed in the second quarter of 2012.

Lonza also is investing CHF 10 million ($10.9 million) to expand its biopharmaceutical development services platform in Singapore. The expansion includes the addition of 1858 m2 of laboratory space and associated equipment and will support cell-line construction, upstream and downstream process development, and analytical services. The facility is expected to come on line in the first half of 2012.

In March 2011, Lonza announced it was investing 16 million ($25.3 million) to further develop the flexibility and capability of its Slough, UK biopharmaceutical manufacturing facility with the construction of a new 60,000-ft2 building adjacent to existing buildings to create a Slough campus. The investment includes a new fermentation suite, new purification suites, new process-development laboratories, and a new GMP warehouse. The project is scheduled for completion by the end of 2012.

In May 2011, Lonza announced an expansion of its viral-based therapeutics business with the construction of a new, cGMP cleanroom located adjacent to its existing Houston, Texas, operations. The expansion provides for large-scale capacity to support late-stage viral vaccine and gene therapy projects. Lonza announced entering the viral manufacturing business through the acquisition of Vivante GMP Solutions in August 2010.

Other firms are making select investments. Hikal has started construction of a new, multipurpose, multiproduct API manufacturing facility, which is scheduled to be operational by June 2012. The plant will consist of two parallel streams and will accommodate 32 reactors with capacities ranging from 6 m3 to 10 m3 for a total reactor volume of approximately 300 m3. The custom manufacturing arm of Dr. Reddy's Laboratories expanded its Chirotech Technology Center at Cambridge Science Park, UK. In April 2011, the company opened a new 33,000-ft2 facility for laboratories and offices. The facility will support the company's capabilities in biocatalysis and chemocatalysis, activated mPEGs, and peptides.


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