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
pharmaphorum
JUNE 22, 2023
Challenges of analytical method validation for ATMPs Mike.Hammerton Thu, 22/06/2023 - 08:00 Bookmark this
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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European Pharmaceutical Review
JUNE 26, 2025
Alternate method validation solutions for recombinant endotoxin testing – a practical approach Endotoxin experts from Charles River provide recommendations on achieving a streamlined transition from LAL to recombinant reagents as an alternative approach to the bacterial endotoxins test (BET).
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…?
European Pharmaceutical Review
MARCH 6, 2024
Additionally, the new laboratory offers Ariceum the ability to carry out on-site process, method, validation and formulation development as well as preliminary stability analysis of its radiolabeled compounds.
ISPE
JUNE 2, 2023
reduce non-value-added tests) Contract lab management Reference standards & critical reagent management Rapid micro testing Training (e.g.,
European Pharmaceutical Review
NOVEMBER 21, 2024
With over 22 years of experience, she has worked as a QC microbiologist in cell therapy and non-sterile pharmaceutical manufacturing, specialising in environmental monitoring and method validation. The post Understanding endotoxin cartridge testing: frequently asked questions appeared first on European Pharmaceutical Review.
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