In October, the WHO published a draft revision of the Guide for the Safe Production and Quality Control of Monoclonal Antibodies. It is a continuation of the guidance documents on this topic that have already existed since 1991.
The GAO report details the number and frequency of FDA inspections of Covid-19 vaccine manufacturers and other biopharmaceutical manufacturers during the pandemic period.
By providing clarification on the designation "Regenerative Medicine Advanced Therapy" , the FDA is providing more clarity on which products may fall in this classification.
In an "Untitled Letter", the FDA requests information from a manufacturer of regenerative therapies based on umbilical cord stem cells on the approval status of the products distributed and used.
In order to take account of the rapid development in the field of biological medicinal products and ATMPs, the PIC/S has revised Annex 2 of its GMP Guideline and made it available for comment.
In December, the FDA updated its guidance on bacterial safety strategies for platelets and platelet preparations, particularly in light of the current implementation difficulties faced by facilities under pandemic conditions.
In January, the Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co-Operation Scheme (PIC/S) published a revised version of its Aide Memoire "Inspections of Biotechnology Manufacturers".
As a complement to the many guidances and documents on the development and manufacture of products from human cells and tissues, the FDA also provides an overview of strategies and approved tests for microbiological testing of donors of cells and tissues.
A regular insight and overview of the activities around ATMP in Europe is provided by the reports on the CAT meetings, which list the latest news on classification, authorisation and much more.
Questions reaching us on the subject of COVID-19 vaccines, their development, approval and production, and on modern platform technologies used are answered in a summary.
