News

Endotoxin and Pyrogen Testing - Challenges for Biotechnological and Biopharmaceutical Products

The introduction of alternative methods as, e.g., the Monocyte Activation Test, is a challenge for many laboratories.

More
Second Chapter of ECA's Microbiological OOS/OOL Guideline announced for May

The ECA's Pharmaceutical Microbiology Group has announced the second chapter of their Guideline on handling microbiological deviations for May. It deals with OOS/OOT and atypical results in endotoxin testing.

More
EMA/CHMP publishes new Q&A Document on Comparability Considerations for ATMPs

A document on the topic of comparability in the context of Changes and Variations at ATMP, published in December by the EMA, respectively the CAT, completes the series of guidelines and assistance around ATMP.

More
FDA publishes Questions and Answers on Pathogen Reduction in Blood Components

With their new questions and answers paper, the FDA wants to provide further information on the implementation of pathogen reduction techniques for blood establishments.

More
Final Guideline on GCP for ATMPs published

The European Commission has now published the final Guideline GCP for ATMP as a further building block of its growing guidance package on  the requirements for Advanced Therapy Medicinal Products.

More
Evaluation of the Immunogenicity of Therapeutic Protein Products - FDA Scientists developed a new Tool

For the important assessment of possible immune responses to therapeutic protein drugs, FDA scientists developed a new mathematical tool to calculate the expected risk of producing antibodies against the biological drug.

More
FDA publishes Q&A on Internal Standard Responses in Chromatography Bioanalysis

In support of sponsors, applicants and research institutions, the FDA examines in more detail the variability of internal standards in analytics and their consequences. The authority has now published a document entitled "Evaluation of Internal Standard Responses During Chromatographic Bioanalysis: Questions and Answers".

More
ATMP from Third Countries - New Q&A Paper on Batch Release published

With a new Q&A document, the EMA has provided information on the release of Adavanved Therapy Medicinal Products (ATMP)  imported into the EU by the Qualified Person without batch re-testing.

More
FDA's promotion for cell and tissue products - the TRG Rapid Inquiry Program (TRIP)

With an additional program to support manufacturers of cells, tissues and cell-based products, the FDA is trying to accelerate its promotion of the development of regenerative therapies.

More
How to handle possibly lifesaving OOS batches of ATMP - A question that concerns manufacturers and authorities

In the context of a Q&A document, the European Medicines Agency (EMA) offers assistance and information on when an Advanced Therapy Medicinal Product (ATMP) can be approved for treatment even in the case of an out-of-specification batch.

More
x