Resources

WuXi Advanced Therapies has added Mycoplasma Real-Time PCR Detection (MycoSEQ™) to our menu of innovative solutions

WuXi Advanced Therapies has added Mycoplasma Real-Time PCR Detection (MycoSEQ™) to our menu of innovative solutions! This assay method can be used for lot release by drugmakers of biotherapeutics, cell therapy products, biologics, and vaccines to detects more than 90 mycoplasma species with high specificity and no cross-reactivity to closely-related bacterial species rapidly and reliably. …Read More >

Resource Type: Publication
Resource Topic: Laboratory Testing

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

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 will illustrate considerations …Read More >

Resource Type: Webinar
Resource Topic: Laboratory Testing

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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: 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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