News for the Pharmaceutical Industry

Wuxi AppTec sends out an e-newsletter approximately every quarter to our contacts in the pharmaceutical industry.

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May 2009

Contents [click on links for full story]

For questions about any of these items or other information on WuXi AppTec’s services, please contact a WuXi AppTec Account Manager.

WuXi AppTec’s Bioanalytical Services Unit Passes FDA Inspection

On March 31, 2009, WuXi AppTec announced that its Bioanalytical Services unit, located in Shanghai, had been inspected by the U.S. Food and Drug Administration (FDA) without the issuance of a Form 483, which is used to report any non-compliance issues after a site inspection.

Established in 2005, WuXi AppTec's Bioanalytical Services (BAS) provides Good Laboratory Practice (GLP)-compliant services to analyze small-molecule drugs using liquid chromatography/mass spectroscopy, and to measure biomarker/biologics and antibody immunogenicity using immunochemistry.

In the FDA review, which took place from March 23 to March 27, the entire BAS facility was inspected and two bioequivalency (BE) studies were audited. The State Food and Drug Administration (SFDA) of China sent four investigators to participate as observers.

"We are very pleased to have passed this audit," commented Dr. Ge Li, Chairman and Chief Executive Officer of WuXi AppTec. "It represents our company's first audit by the U.S. FDA and the first such audit of any bioanalytical laboratory in China. WuXi AppTec will continue to pursue the highest levels of quality and transparency to meet and exceed FDA requirements."

"As a GLP-compliant facility, BAS always treats quality and compliance as our highest priorities," commented Dr. Jinsong Xing, Executive Director of BAS of WuXi AppTec. "We maintain GLP readiness through continuous training, review of technology, and rigorous proficiency testing. Our quality control team thoroughly reviews all data and closely monitors the facility for compliance on a daily basis."

"Quality is our watchword, and continuous improvement in quality is the foundation of our success," echoed Mr. Robert Coldreck, Vice President of GLP Quality Assurance for WuXi AppTec.

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WuXi AppTec’s Toxicology Facility in Suzhou Passes Audit, Adds Three Senior Executives

Building on the strengths of its scientific expertise and years of experience in providing testing services to the pharmaceutical industry, WuXi AppTec undertook an ambitious expansion into a new service area:  high-quality non-clinical drug safety evaluation services. Established in October 2006, the subsidiary WuXi AppTec (Suzhou) Co., Ltd. has recently completed construction of a new drug safety evaluation center located in Suzhou, China. Covering an area of over 30,000 square meters, the facility is one of the largest of its kind in Asia.  On March 25, 2009, the center passed the audit for permission for laboratory animal use in Jiangsu Province.  Receiving the license for laboratory animal use symbolizes the formal opening of operations at the Suzhou facility and the ability to undertake preclinical drug evaluation services for customers worldwide.  The facility will begin providing its global customers with GLP genotoxicity studies in the third quarter of 2009.  Looking forward, the Suzhou facility will begin offering GLP general toxicology services in 2010 (with GLP accreditations from SFDA and OECD), and full preclinical safety evaluation services in 2013.

Leading the operations at the Suzhou facility is a strong scientific research and management team with deep experience in toxicology and pathology. On March 24, 2009, WuXi AppTec announced the addition of three senior executives for its Suzhou facility.

Dr. Brian J. Xu has joined WuXi AppTec as Vice President of Toxicology and Head of the Safety Evaluation Center at Suzhou, reporting to Dr. Ge Li, Chairman and Chief Executive Officer.  Dr. Xu is an American Board Certified Toxicologist (DABT) and has worked previously at Merck, Roche, Schering-Plough and Enzon. Dr. Xu received a Ph.D. from George Washington University and did post-doctoral research at Yale University.

Dr. Yang-Dar Yuan has joined the company as Vice President of Operation and Head of Pathology of the Safety Evaluation Center, reporting to Dr. Brian Xu. Dr. Yuan is a member of the American College of Veterinary Pathologists (ACVP), a member of the American College of Laboratory Animal Medicine and an American Board Certified Toxicologist (DABT). He has more than 30 years’ experience in preclinical safety assessment and drug development, and has worked previously at Upjohn, Pfizer, Allergan and Vitae Pharmaceutical. Dr. Yuan received a D.V.M. from National Taiwan University and a Ph.D. in Veterinary Pathology from Cornell University.

Mr. Robert Coldreck has joined the company as Vice President of GLP QA (Good Laboratory Practice Quality Assurance). Mr. Coldreck has previously worked at Novartis, most recently as Director of Laboratory and Preclinical Quality Assurance – North America and Asia, and has more than 30 years’ experience in GLP quality assurance. Mr. Coldreck received his B.S. in Biology from Fairleigh Dickinson University.

"I am delighted to welcome Brian, Yang-Dar and Bob to our management team, as they bring rich experience, knowledge in GLP preclinical studies and strong leadership in their respective fields,” said Dr. Li.  “With our new safety evaluation center, WuXi AppTec continues to build a world-class preclinical service platform to meet our customers' needs."

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Commercial Manufacturing Capabilities Are Expanded

WuXi AppTec has commenced validation of its new 350,000-square-foot commercial manufacturing plant, located at the company’s research and commercial manufacturing site in the Jinshan area of Shanghai.  The addition of the new plant quadruples the manufacturing capacity at the Jinshan site, which also includes a 220,000-square-foot cGMP-quality process development and manufacturing plant.

Multi-certified (ISO 9001:2000, China FDA and GMP Manufacture) as well as multi-purpose, the new plant can run three products concurrently.  Features include 18 reactors (with capacities ranging from 8,000 to 20,000 L) and cryogenic capability as low as -78°C (with 10,000 L scale).  In addition, the plant is automation-controlled to ensure the robustness of the processes running in the facility.  Annual capacity is projected to be 50-100 metric tons.

WuXi AppTec’s process development and manufacturing plant became operational in 2003, and since has passed 36 customer quality audits – demonstrating full compliance with US and European cGMP guidelines – as well as eight EHS audits.  The plant offers full CMC services – from APIs to drug products – and has produced over 50 APIs to date for US and European clients for clinical trails at different phases. 

The newly expanded facility is expected to complete the commercial facility qualification and validation in Q2 of 2009 and will allow WuXi to provide services from milligram to metric tons to support commercial products.  Other features of the expansion include: two isolated API finishing areas, each classified at 100,000; high-temperature capability (as high as 300°C); GMP kilo labs (classified at 100,000 for handling production of APIs); high-pressure reaction capability; and bilingual SOPs, Q7A guided.

“We built the commercial GMP facility to further integrate our manufacturing services from pilot scale, to large scale, to commercial scale,” said Dr. Suhan Tang, Chief Manufacturing Officer, WuXi AppTec. “With all the capabilities at the same site, our customers will enjoy smooth technology development through different stages and avoid the need for any technology transfer between different sites.  As a result, the overall development timeline will be shortened.  We can provide value-added services in a more cost-effective manner to better serve our customers’ needs.”

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WuXi AppTec Continues to Recruit New Scientists for Expanded Business Despite Economic Crisis

With steadily increasing customer demand, despite the current economic crisis, WuXi AppTec continues expansion of its service portfolio, while adding talented, experienced team members to meet the needs of our customers.

Currently, there are over 3,800 employees at WuXi AppTec, including 2,900 scientists, over 2,800 of whom hold Master’s or Ph.D. degrees.  Our senior management team is made up of professionals with Ph.D.s and MBAs, with an average of 15 years’ experience working in major international pharmaceutical, biotechnology, and medical device companies.

In 2009, WuXi AppTec expects to recruit approximately 1,000 new scientific staff for its expanded business.

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UPCOMING MEETINGS

WuXi AppTec will be exhibiting at these upcoming meetings:

  • BIO Convention – Atlanta, GA – May 18-21
  • ChemOutsourcing – Long Branch, NJ – September 14-16
  • Contract Pharma – New Brunswick, NJ – September 24-25
  • CPhI – Madrid, Spain – October 13-15
  • American College of Toxicology – Palm Springs, CA – November 1-4
  • AAPS – Los Angeles, CA – November 9-12

Please come by to discuss your outsourcing needs.

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