Challenges of analytical method validation for ATMPs
pharmaphorum
JUNE 22, 2023
Challenges of analytical method validation for ATMPs Mike.Hammerton Thu, 22/06/2023 - 08:00 Bookmark this
Method Validation Related Topics 
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EMA publishes updated Q&A for ICH M10
European Pharmaceutical Review
JANUARY 26, 2023
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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Endotoxin testing: the international regulatory landscape
European Pharmaceutical Review
APRIL 2, 2024
Timely implementation of the reference to USP <86> in the water for injection and purified water monographs is desired to encourage and enable the adoption of these methods for environmental monitoring purposes. Want to learn more about endotoxin testing and validation…?
Bioassays for Gene Therapy Products
BioPharm
MARCH 16, 2023
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.
ISPE QC/Analytical Community of Practice Established
ISPE
JUNE 2, 2023
reduce non-value-added tests) Contract lab management Reference standards & critical reagent management Rapid micro testing Training (e.g.,
SMi’s 10th Annual Pharmaceutical Microbiology UK Conference
pharmaphorum
DECEMBER 16, 2021
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.
CoP Leader Profiles: Roujian “RJ” Zhang
ISPE
MAY 10, 2023
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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