Narrowing the Geographic Divide in API Sourcing - Pharmaceutical Technology

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Narrowing the Geographic Divide in API Sourcing
Contract manufacturers deploy a business model using operations in the US and Western Europe with facilities in Asia.


Pharmaceutical Technology
Volume 33, Issue 3, pp. 80-86

Building bridges to China

Wuxi AppTec (Shanghai), a contract research and manufacturing organization, expanded into the US in 2008 with the acquisition of AppTec Laboratory Services, a provider of testing, contract research and development, and biologics manufacturing services. In China, the company recently quadrupled the chemical manufacturing capacity at its Jinshan site with a new 350,000-ft2 commercial manufacturing plant. The plant features 18 reactors with capacities ranging from 8000 to 20,000 L. It also has cryogenic capability at a 10,000-L scale. Annual capacity of the plant is projected at 50–100 metric tons. Other plant features include two isolated API finishing areas, each classified at 100,000; high-temperature capability; GMP kilo laboratories (classified at 100,000 for handling production of APIs); and high-pressure reactions.

Taking advantage of its sourcing capabilities and knowledge base, Wuxi AppTec recently introduced a new global procurement service (GPS), which will assist customers in navigating purchasing low-cost commercial reagents from qualified vendors in China. The GPS services also include quality-control testing, certificates of analysis, repacking, relabeling, and export services.

Asymchem Laboratories, with headquarters in Morrisville, North Carolina, and R&D and production facilities in China, is expanding both in size and in services. Asymchem is converting its existing non-CGMP pilot plant in Tianjin, China into a CGMP high-potency kilo laboratory/pilot plant, which will open in the second quarter of 2009. In June 2008, the company opened a new R&D and analytical research center (Tianjin Life Science Center) to complement its existing CGMP pilot plant there. The new R&D laboratory employs approximately 300 chemists and provides services for medicinal chemistry, process safety, engineering evaluation, and process development. The 100,000-m2 site in Tianjin focuses on R&D for new technology of drug synthesis, process development and scale-up, CGMP API development and production support, final-dosage development and manufacturing, analytical methods development, solid-state studies, toxicity testing and formulation R&D. The second stage of construction of the Tianjin site is ongoing and includes buildings to house biological testing and a CGMP formulation production plant.

To meet increasing commercial requirements of customers, Asymchem is building a new site in northeastern China (Dunhua). The Dunhua site, which is scheduled to open in the third quarter of 2009, will have CGMP facilities for bulk synthesis of late-stage intermediates and APIs plus large-scale non-GMP facilities for producing key starting materials.

At this year's InformEX, the annual exhibition of custom and batch manufacturers that was held in San Francisco in late January, a sampling of exhibitors showed other companies emphasizing a US–China hybrid model. Some examples include AmbioPharma (North Augusta, SC), APAC Pharmaceutical (Columbia, MD), AstaTech (Bristol, PA), Chemlex Pharmaceuticals (Pleasanton, CA), ChemPacific (Baltimore), Laviana (San Ramon, CA), and PHT International (Charlotte, NC).

Implications

The importance of these global relationships reflects the changing competitive landscape. A recent member survey by the Synthetic Organic Chemical Manufacturers Association, the US-based trade association representing batch and custom manufacturers, shows increased penetration by CMOs from emerging markets. The mean market share held by suppliers from the emerging markets of India, China, Eastern Europe, and Latin America was 26.5% in 2008, and this level is projected to increase to a mean of 30.8% in 2009, according to the survey. If the survey is an indication, these competitive dynamics will continue.

Patricia Van Arnum is a senior editor at Pharmaceutical Technology, 485 Route One South, Bldg F, First Floor, Iselin, NJ 08830 tel. 732.346.3072,


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