Knowledge Library

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: Advanced 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: Advanced Testing

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BIO 2019 recognizes WuXi AppTec

WuXi AppTec’s enabling capabilities and contribution to the development of life science were recognized by both its many partners and the City of Philadelphia at the BIO International Convention 2019. The BIO International Convention is hosted annually by the Biotechnology Innovation Organization (BIO), which represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers …Read More >

Resource Type: Article
Resource Topic: Advanced Testing Clinical & Commercial Manufacturing

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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
Resource Topic: Advanced Testing 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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