Resources

Accelerating viral vectors commercialization through AAV suspension platform

  Summary of the Presentation given at Phacilitate in Miami (2020): – Established suspension HEK293 cell line – In-stock raw materials with established batch records – State-of-the-art GMP manufacturing facilities with enhanced scalability that range up to 1000L – Established and dedicated process & analytical development teams – Strong and dedicated technical guidance including regulatory …Read More >

Resource Type: Presentation
Resource Topic: Clinical & Commercial Manufacturing

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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 Video Webinar
Resource Topic: Advanced Testing

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Updated methods for single use components

Leachables from single use systems can impact your drug product. This presentation will help guide you through those risks and present some options for test methods.

Resource Type: Presentation
Resource Topic: Clinical & Commercial Manufacturing

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Refining platforms for accelerated viral vector production and release

Presentation on Refining Platforms for Accelerated Viral Vector Production and Release, by John Hughes, PhD. Speaks to our journey as a company at WuXi, and how we strive to accelerate progress and time to market. Outlines our platform components and advantages, as well as illustrating our particular technologies & services through a few case studies. …Read More >

Resource Type: Presentation
Resource Topic: Advanced Testing

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Cell line authentication: Species identity and purity analysis using next generation sequencing

December 2017 Cell Line Authentication: Species Identity and Purity Analysis Using Next Generation Sequencing Christine Mitchell, Scientific Fellow, Technical Development Group Cell Line Authentication assays using Targeted Next Generation Sequencing methods Cell Line Identity – Method overview Qualification of the Cell Line Identity Method Cell Line Purity – analyze for presence of 19 potentially contaminating …Read More >

Resource Type: Presentation
Resource Topic: Advanced Testing

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