Resources

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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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: Laboratory 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: Analytical Development Laboratory Testing

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Validation of a PCR method for the detection of mycoplasmas according to European Pharmacopoeia section 2.6.7

Recent publication of a revised section for mycoplasma testing in the European Pharmacopoeia [1] has led to interest in validating a nucleic acid amplification technique (NAT) for use in detection of mycoplasma contaminants in biologics drugs. The replacement by or supplementation of the existing culture-based methods with a PCR-based method has several advantages for the …Read More >

Resource Type: Publication
Resource Topic: Laboratory Testing

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