The FDA has finally released its biosimilar draft guidance for industry, which details how it will evaluate comparative analytical characterization of the biosimilar in relation to the reference product.
Though industry has fully embraced single-use, manufacturers of such systems need to remove the risk of extractables and leachables and control the supply process according to Sartorius.
Novartis says stem cell-based therapies will form an important part of its pipeline after reports in the Israeli media the firm pulled out of a deal to buy Gamida Cell.
