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WuXi Biologics expands its biosafety testing capacities by adding a new facility in Suzhou, China.  The 38,000 sq. ft. facility has been operational since December 2014 and provides viral clearance studies, cell line characterization and lot release testing services.  We had the opportunity to sit down with Dr. Paul Liu, Vice President and Head of this new biosafety testing facility,  to learn more about him and the future of biosafety testing services in China.

What inspired you to join WuXi after over 25 successful years at biotech companies?

Paul: WuXi has built an amazing organization with superb capabilities and a world-class reputation to match.  I am proud to support the mission and commitment of WuXi, and eager to contribute to the rapid growth of our industry in China and Asia.

What can you tell us about the new biosafety facilities in Suzhou, China and what goal do you aspire  to achieve?

Paul: Our laboratory is the first of its kind in China and Asia, i.e. a non-state affiliated third-party biosafety testing services provider focused on viral safety.  We have available the best practices and technologies from the US and we operate to global quality standards.  Last year, it was challenging to promote this new paradigm against the status quo, but we have become well established now.  That said, we will continue to improve so that we can remain a market leader.

How do these services fit into the product development process for our clients?

Paul: All of our clients are involved in the GMP manufacturing of biotherapeutics, albeit many in early stages of development.  Inherent in the use of mammalian cells for the manufacture of biopharmaceuticals is the risk of introducing viral or other microbiological contaminants into the production process.  We provide services that screen for viruses and other microorganisms in the cell lines and raw materials used during production.  Another critical requirement that we can fulfill for our clients is to ensure that their purification scheme can remove and inactivate virus should it somehow enter the production process.  All regulatory drug filings require this validation.  Since the biopharmaceutical industry is relatively young here, we can both educate and assist clients to meet these rigorous demands for product safety and quality.

With these services already established in the US, why duplicate the labs in China?

Paul: Our testing lab makes WuXi Biologics unique among contract development and manufacturing organizations (CDMOs) in Asia as we can perform this important task in-house.  Coupled with WuXi Biologics’ other comprehensive services and the vast capabilities of our affiliates, we are truly the only single-source service provider in the world for drug development and manufacturing.  In addition, our location makes it convenient to serve a potentially huge market, where the industry is developing rapidly.  With our familiarity of the local language and culture, we can more readily share our technical expertise and regulatory knowledge to benefit our clients and partners.

Did the US biosafety team assist in the efforts to develop the services in China?

Paul: Our US colleagues did a lot more than assist.  They anticipated the market potential and the importance to extend the commercial reach of their industry leading services to China and Asia.  Our Suzhou China facility is designed to replicate the services provided in the US, by employing the same test methods, equipment, and critical raw materials including proprietary cell and virus banks.  The US biosafety team helped recruit the Suzhou leadership team, provided operational guidance and much of the senior staff training.  Moving forward, we expect to continue collaborating with our US colleagues to address the challenges of our ever changing marketplace and to seek advice on some of the more complex projects.

How do you expect to create value for your clients/partners?

Paul: As mentioned earlier, our one-stop service offering is one of the key areas where we can provide value.  Reducing the number of vendors provides significant efficiencies and cost savings for our clients.  Furthermore, we shall follow the core values of WuXi AppTec – client first, ownership, respect, excellence, and accept every business opportunity as a challenge to prove ourselves and earn our client’s trust and confidence.  To us, the client’s best compliment is their repeat business and that we will never forget.

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