GMP News - Blood / Biologics and ATMP

The complexity of therapeutic protein-based medicinal products makes characterisation of these products difficult. However, the use of artificial intelligence and machine learning in flow imaging microscopy opens up new possibilities.

With the guidance "Identification of Medicinal Products - Implementation and Use" published in March, the FDA addresses all those involved in the submission of medicinal product data.

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published the 21st edition of the "Guide to the preparation, use and quality assurance of blood components".

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).