EMA: New Q&As for Biological Medicinal Products
The EMA has added a new section to its Q&As on biological medicinal products addressing medicinal products containing secretomes or extracellular vesicles (EVs) obtained from human or animal cells.
The four new Q&As cover quality requirements for the active substance and starting cells, requirements for culture media, and viral safety. Among other aspects, EMA expects comprehensive characterisation of the products and their Critical Quality Attributes (CQAs). The principles of ICH Q5D should be applied to the starting cells, while ICH Q5A(R2) should be considered for viral safety.
Particular attention is given to culture media: as the manufacture of secretome medicinal products typically involves only limited purification steps, the media should meet requirements at least equivalent to those applicable to excipients. They must be manufactured under appropriate GMP conditions. EMA also encourages the use of standardised and fully defined as well as serum-free media whenever feasible.
Source:
EMA: Questions and answers for biological medicinal products
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