FDA Updates Guidance for Analytical Procedures and Methods Validation

In July, the FDA published “Analytical Procedures and Methods Validation for Drugs and Biologics Guidance for Industry”. This new guidance document replaces the original 1987 guidelines and the previous draft guidance documents and provides recommendations for submission of analytical procedures and method validation data. The recommendations cover drug substance and drug products in BLAs, but should also be considered when preparing INDs. (Learn more)


Innovative Cell-based Potency Assay for Therapeutic mAbs against PD-L1
The bioassay group at WuXi Biologics has developed an innovative cell-based potency assay for therapeutic mAbs against PD-L1. The assay is MOA-reflective and QC-friendly and it measures the inhibitions of homogeneous binding of PD-L1 to PD-1 expressing cells by the therapeutic mAbs and closely mimics the expected clinical responses. The assay is part of a WuXi patent and can be transferred to clients upon request. There is no similar method available on the market currently and such assay is a requirement for IND filing with CFDA. (Learn more)

Viral Clearance: Impact of Virus Quality and Spike Level
Viral clearance studies are a critical component of a risk-based approach to viral safety for biopharmaceutical development. While most companies during these studies focus on the performance of individual downstream manufacturing process steps, the impact of viral stock quality and the virus spike levels used in the study cannot be overlooked. These various aspects are discussed in a new paper published in Biotechnology Progress.

New
Technical Webinar: Strategies for ADC Development
This webinar reviews the technical approaches of the past and current strategies for designing these complex cancer therapeutics and provide helpful case studies and tools for your own ADC development efforts.

WuXi AppTec Collaborates with University of Pennsylvania to Produce Gene Therapies
WuXi AppTec has formed a strategic manufacturing collaboration with University of Pennsylvania’s Gene Therapy Program. The collaboration will combine Penn’s significant expertise in viral vector production developed over 20 years with the manufacturing expertise and infrastructure of WuXi AppTec. Scientists from Penn will work with WuXi to establish efficient, scalable manufacturing processes within cGMP guidelines for the production of viral vectors at WuXi’s 145,000 square-foot state-of-the-art manufacturing facility currently under construction at The Navy Yard in Philadelphia. (Learn more)

WuXi Biologics Constructs New Biosafety Testing Facilities in China
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. It is the first non-state affiliated lab to offer this type of service in China and Asia. The expansion is part of WuXi’s continuing commitment to build the world’s one true single-source service platform for its global customers and deliver cost and time efficiency for drug development. (Learn more)

U.S. Biologics Services has Web-Enabled Sample Submission Forms
The Biologics Sample Submission Form (SSF) is a web-enabled/HTML tool that ensures the most current version of the form is submitted avoiding possible compliance issues and helping ensure a trouble-free start to a project. The SSFs allow auto-filling of certain information, such as test names, and a new feature is being added to automatically highlight fields with missing content. This new feature will confirm the form is complete prior to saving, printing and submitting with your samples. Access all our HTML test request forms and accompanying tutorials here http://www.wuxiapptec.com/test-request_form.html.

Meet Our Experts
10/19-22: World ADC San Diego (San Diego, CA)
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