News for the Biologics Industry

WuXi AppTec sends out an e-newsletter approximately every quarter to our contacts in the biologics industry. To access previous issues, click here.

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August 2009

Contents [click on links for full story]

NEWS FROM WUXI APPTEC

WuXi AppTec Develops qPCR Assay for Vesivirus 2117
Recent press releases from a pharmaceutical company indicated that the production process in one facility experienced a viral contamination. The virus was identified as a Vesivirus (Strain 2117). Vesivirus is a 32-40 nm non-enveloped RNA virus in the Calicivirus family. The impact of this event to the biopharmaceutical industry as a whole is still to be determined. It is conceivable that future regulatory or industry recommendations in response to this event will require a definitive evaluation of mammalian-derived products, the raw materials that are employed, as well as the purification processes for Vesivirus detection or removal. To assist companies in this evaluation, Wuxi AppTec has developed a qPCR assay for Vesivirus 2117, and will offer a Calicivirus model that can be used to evaluate the capability of purification processes to remove or inactivate this potential viral contaminant.

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Cell Therapy Manufacturing and Cell Banking Services Reach Milestones
WuXi AppTec’s cell banking and cell therapy manufacturing programs reached significant milestones earlier this year, having created more than 250 cGMP cell banks and 250 cGMP cell therapy production lots, including seven distinct new cell therapy manufacturing projects – both allogeneic and autologous products. And the programs – established more than five years ago – continue to grow as WuXi AppTec’s experience, strong scientific staff and state-of-the art facility attract a broad array of cell therapy and cell banking clients.

The 16,000-square-foot GMP cell therapy facility at WuXi AppTec’s Philadelphia site consists of one autologous processing suite and five allogeneic suites plus five cell banking suites. Each maintains a single-pass class 10,000 background with class 100 sterile cabinets within. The facility is operated according to cGMP guidelines, with all appropriate control and support systems in place to meet or exceed required regulatory compliance. In addition, WuXi AppTec laboratories provide a full menu of associated biologics testing programs.

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INNOVATIONS

Particulate Testing Now Available
Numerous agencies have published guidelines for measuring the number and size distribution of particulate matter in pharmaceutical products, medical formulations, and devices. Most notable are USP Chapters <788> and <789> that describe procedures and specifications for “Particulate Matter in Injections” and “Particulate Matter in Ophthalmic Solutions” respectively. WuXi AppTec now has available the Hach HIAC Model 9703 Liquid Particle Counting System, a light obscuration instrument that is ideally suited to measure particles from small- and large-volume parenterals as well as samples from water for injection (WFI) systems or fluids used for cleaning medical devices and precision parts. The HIAC 9703 offers full compliance with 21 CFR Part 11 and has been validated for USP <788> testing. The PharmSpec Version 2 software also allows for seamless development of custom particulate-measuring programs. The 9703 can detect and quantitate particles in the size range of 1.5 to 150 microns.

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Genetic Sequencing Added to Microbial Identification Services
WuXi AppTec’s Microbial Identification Department performs over 5,000 microbial identifications per year using multiple identification techniques and systems. With the addition of the Applied Biosystems 3130/3130x Genetic Analyzer, bacteria, yeasts, and molds can now be identified through specific gene sequencing. The unique comparative analysis of both forward and reverse PCR reactions allows for more accurate, dependable and reliable results.

In addition to the 3130/3130x Genetic Analyzer, WuXi AppTec continues to offer a full array of techniques and instrumentation for microbial identification including:

  • VITEK® 2 Compact Microbial Identification System A fully automated biochemical system made by BioMerieux for identifying bacterial and yeast samples, it makes use of 64 different biochemical reactions and is capable of identifying samples in as little as two hours
  • RiboPrinter® Microbial Characterization System. Made by DuPont, it performs an automated Southern blot using a ribosomal DNA probe to create a “genetic fingerprint” or RiboPrint® pattern, which can be compared against a database containing over 7,000 bacterial patterns
  • BBL Crystal™ Rapid Gram-Positive Identification System Contains 29 fluorogenic, chromogenic, and modified conventional substrates for the identification of a wide range of Gram-positive bacteria.
  • Standard Macroscopic and Microscopic Fungal Identification

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Vial Integrity Testing
For sterile biopharmaceutical products, sterility is considered a characteristic to be included and evaluated in any stability testing program. The U.S. FDA “Guidance for Industry – Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products” indicates that methods to test the integrity of the container, closure, seal configuration of a product might be more reliable than standard sterility test methods in evaluating continued sterility throughout that product’s shelf life. As an integral part of any stability testing program, WuXi AppTec now offers dye immersion testing, a way to detect failures such as cracks, seams and laminations through leaks or lack of fusion. This procedure can be used on various types of container, closure, seal configurations such as nonporous metallic materials (ferrous and non-ferrous) and nonmetallic materials such as glazed ceramics, certain nonporous plastics, and glass. More cost-effective than USP sterility testing, the turnaround time for the dye immersion test is typically 2 to 3 business days. The number of test samples that are used for this test are at the discretion of the sponsor.

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MEETINGS & PRESENTATIONS

Parenteral Drug Association Cell Substrate Workshop
Dr. Garry Takle, WuXi AppTec's Vice President of Operations for the Philadelphia site, and Co-Leader of the New Cell Lines Subgroup of the PDA Cell Substrate Task Force will be attending the PDA Cell Substrate Workshop in Bethesda, Maryland, July 29-30. The meeting will focus on upstream issues and challenges encountered when using banked mammalian and insect cell lines. Also attending will be Ms. Dana Cipriano, Director of Project Management, who has nine years experience in the design and execution of viral clearance studies. Attendees are welcome to meet with Garry and Dana and to discuss their cell bank, testing, and viral clearance questions.

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Sartorius Downstream Technology Forum
Dana Cipriano, Director of Project Management for the Philadelphia site, gave a presentation titled “Overcoming a Safety Challenge in Biomanufacturing: Update on New Virus Preparations Used in Viral Clearance Validations” at the Sartorius Downstream Technology Forum, June 16-17. The presentation focused on the selection, preparation, purification and storage of viral stocks, which are some of the most critical elements for successful viral clearance programs and for achieving accurate viral clearance data. WuXi AppTec has developed improved methods to purify the mammalian viruses that are routinely used in viral clearance studies. While ultracentrifugation of viruses has been sufficient for many years in the preparation of viruses, these preparations have sometimes proven to be less efficient for viral removal filters (nanofiltration process steps). Nanofiltration steps are considered robust steps for virus removal and typically yield log reduction values on the order of greater than 4 logs. Some potential challenges in achieving these log reduction values can be aggregation or plugging of the membrane. Ms. Cipriano discussed how WuXi AppTec has made several modifications that significantly reduce host cell nucleic acid and protein contamination leading to purer preparations of virus. These improvements can potentially increase the overall log reduction for the step and the throughput volume processed during filtration. She presented data on these new preparations and their QC analyses as well as some performance on viral removal filters and their impact on overall viral clearance schemes. Viral preparations are now being made available for the commonly used MMV and PPV parvoviruses for filtration studies, which should prove capable of providing robust log reduction values while increasing the amount of product that can be processed during purification. Other viruses are also being examined and preliminary data will be discussed.

A copy of the slide presentation is available. Please contact your Wuxi AppTec Account Manager.

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IBC Cell Line Development and Engineering Meeting
WuXi AppTec exhibited at the IBC Cell Line Development and Engineering Meeting in La Jolla, CA, June 22-24, where our representatives provided information on WuXi AppTec’s expert cell line development group. Headed by Dr. ChiChang Lee (who has over 17 years experience in cell line development), the group offers a broad spectrum of services including gene cloning/ synthesis, vector construction, reagent generation by microbial or mammalian transient expression, tranfection/electroporation, stable cell line creation, purification, bio membrane preparation, bioreactor process development, downstream process development, analytical method development and chemically defined medium development.

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2009 BIO International Convention
WuXi AppTec participated in the 2009 BIO International Convention, produced by the Biotechnology Industry Organization (BIO) and held this year in Atlanta, Georgia (USA), May 18-21. The meeting brought together 14,352 industry, government and academic leaders from 58 countries and 48 states. Attending from Wuxi AppTec were Edward Hu, Steven Hutchins, Trabue Bryans, Thomas Voss and Steve Farmer. The BIO Exhibition, a popular part of the convention, involved 1,827 exhibitors and covered an estimated 176,000 square feet. WuXi AppTec’s booth — which was part of the large China exhibit — provided the opportunity to meet with many current and potential customers. The full Convention program featured more than 170 sessions in 22 breakout session tracks, including new tracks on drug delivery, global biotechnology issues, translational medicine and vaccines, among others. WuXi AppTec’s Chief Operating Officer, Edward Hu, was a featured speaker for one of the breakout sessions: “When East Meets West - How to Get Deals Done and Build Enduring Relationships,” which focused on issues to be considered in cross-border and cross-cultural technical collaborations, strategic partnering, R&D outsourcing, mergers and acquisitions and subsequent integrations. He also participated as a panel member in another session titled “Global Bio-Pharmaceutical R&D Hub in China,” which centered on the premise that a fast-growing economy has attracted excellent talents back to China and greatly improved the R&D capabilities of Chinese biotech companies and research institutes. As international quality standards have been established, many multinational companies have increased their R&D establishments and collaborations in China. The session illustrated why and how China can become an international R&D hub for the global biopharmaceutical industry.