By providing information on the safety of cell and tissue products in relation to coronavirus, the FDA gives support in questions of transferability by donors.
Testing for virus contamination plays an important role in blood and blood components. Recently, the FDA has published a guidance document on testing for T-lymphotropic viruses by means of serological testing.
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.
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.
With their new questions and answers paper, the FDA wants to provide further information on the implementation of pathogen reduction techniques for blood establishments.
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.
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.
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".
