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Challenges of analytical method validation for ATMPs

pharmaphorum

Challenges of analytical method validation for ATMPs Mike.Hammerton Thu, 22/06/2023 - 08:00 Bookmark this

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EMA publishes updated Q&A for ICH M10

European Pharmaceutical Review

The European Medicines Agency (EMA) has published an updated Q&A document regarding ICH M10 ‘Bioanalytical Method Validation and Study Sample Analysis’. The ICH M10 guideline provides recommendations on the validation of bioanalytical assays for chemical and biological drugs and their metabolites in biological matrices.

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Bioassays for Gene Therapy Products

BioPharm

Gene therapy products require extensive experience in bioassay development, optimization, phase appropriate method validation/transfer, as well as assay maintenance to support routine lot release and stability testing. Learn how Eurofins BioPharma Product Testing can support your gene therapy products.

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ISPE QC/Analytical Community of Practice Established

ISPE

reduce non-value-added tests) Contract lab management Reference standards & critical reagent management Rapid micro testing Training (e.g.,

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SMi’s 10th Annual Pharmaceutical Microbiology UK Conference

pharmaphorum

Gain insight the current state of Endotoxin testing, including alternative test methods and strategic approaches to method validation. Key Reasons to Attend: Discover case studies in establishing holistic Contamination Control Strategies and Real-Time Viable Air Particle Counting with leaders in the pharmaceutical industry.

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CoP Leader Profiles: Roujian “RJ” Zhang

ISPE

The ISPE QC/Analytical CoP was established in 2022 to provide a forum for knowledge sharing on a range of topics including out of specification (OOS) investigations, method validation, compendial harmonization, analytical methods lifecycle management, and implementing innovations, such as real-time release.

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Life-Cycle Approach to Cleaning Topical Drug Products

ISPE

The cleaning validation life-cycle approach consists of three stages: design, qualification, and continued verification. Often referred to as the validation stage, stage two: qualification confirms that the cleaning procedure under normal conditions meets preestablished acceptance criteria.