Resources

Case Study in Conducting Chemical Safety Assessments for Single- and Multi-Use Manufacturing Components

About this event Extractable and leachable studies of single- and multi-use manufacturing components should be followed up with a chemical safety assessment to understand the chemical risks based on the toxicity of the chemical, the dose and the exposure duration of the drug product, and the patient population for its intended use. This case study …Read More >

Resource Type: Webinar
Resource Topic: Laboratory Testing

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Meeting on the Mesa: THE EVOLUTION OF CELL AND GENE THERAPY IN CHINA

Senior executives active in the region will share their experience and outlook on the cell and gene therapy industry in China, with advice for those considering expansion or are new to the market. Click the Image Below to View the Webcast Now on YouTube:  

Resource Type: Video Webinar
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WebCast: Accelerating Development and Manufacturing Platforms for Viral Vectors

This webcast features: Bai-wei Gu, Head of the Cell Line Development Group, WuXi Advanced Therapies Developing innovative advanced therapies is one of our greatest opportunities to dramatically improve patients’ lives. In this webinar, we will discuss our recent technical advancements in efficient viral vector manufacturing process development. From cell line development, to suspension culture of …Read More >

Resource Type: Webinar
Resource Topic: Process Development

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Navigating Regulatory Expectations for Extractables and Leachables of Combination Products

The expectations for extractables and leachables of medical devices (delivery systems) are different than those of typical pharmaceutical applications such as container closure systems or single use systems. Learn about how the FDA reviews combination products and learn about testing expectations. Put these expectations to practice with a case study review complete including common pitfalls …Read More >

Resource Type: Presentation Webinar
Resource Topic: Laboratory Testing

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Updates to Characterization Methods for Single Use Plastic Components Used In Pharmaceutical and Biopharmaceutical Manufacturing

This webcast features: Sandi Schaible, Senior Director, Analytical Chemistry and Regulatory Toxicology, WuXi AppTec Leachables from single use systems have the potential to impact the quality and safety of your drug product. This presentation will help you understand those risks and how to evaluate them, the current options for test methods and what the future holds …Read More >

Resource Type: Webinar
Resource Topic: Process Development

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