Filtration is one of the most commonly used unit operations in the manufacturing of biopharmaceuticals. This is the second part of the fourth article in the "Elements of Biopharmaceutical Production" series. In this second segment, Manoj Menon and Frank Riske present an approach for the development and optimization of a TFF application, followed by a contribution from Jennifer Campbell and Elizabeth Goodrich reviewing key issues involved in validation of a TFF step.
Filtration is one of the most commonly used unit operations in biopharmaceutical manufacturing. Available formats include direct or normal flow filtration (NFF) and cross or tangential flow filtration (TFF). These methods are used for sterilization and virus filtration, depth filtration or ultrafiltration, and diafiltration applications. Some common objectives include: