GMP News - Blood / Biologics and ATMP

After 2019 and 2021, the FDA will again update its findings and recommendations regarding bacterial contamination of platelet preparations for transfusion purposes.

In January you could read about the publication of the revised ICH Q9 guideline. What is new with regard to quality risk management (QRM)?

In October, the EMA published a revised version of "ICH: Q 5 A (R1): Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin" for consultation.

With the publication of a question and answer guideline, the FDA is responding to the challenges of the shortage of disposable materials in manufacturing and the requirements for the use of alternative materials in the area of chemistry, manufacturing and controls (CMC).

After the revision in 2017, the Monograph 2.6.30. Monocyte Activation Test in the European Pharmacopoeia undergoes a new revision which is open for comments until the end of June.

Questions - and answers about Bioburden. A first excerpt of the most important questions during the ECA Bioburden Workshop.

With a draft guidance for the development, manufacture and control of chimeric antigen receptor (CAR) T cell products, the FDA is expanding its recommendations for advanced biological products and providing further guidance to developers and manufacturers.