Jennifer Markarian

BioPharm International spoke with Colleen Floreck, vice president, Global Marketing and Strategy, Catalent Cell and Gene Therapy about the specific requirements and challenges for expanding production of viral vectors.

Flexible and efficient methods are needed for biopharmaceutical manufacturing.

The continuous, aseptic fill/finish process is finding use in vaccines and biologic drugs.

Innovations aid efficient processing.

Isolators move into smaller-volume processes, including cell and gene therapy manufacturing.

Disposable equipment components find use in small-volume aseptic biopharmaceutical manufacturing.

A new GMP facility in Raleigh, NC, and a starting materials facility in Paris, France, give Cellectis end-to-end, in-house manufacturing capacity for its UCART product candidates.

Mechanistic models provide process understanding for developing robust manufacturing processes and for scale up and tech transfer.

Models of biopharmaceutical processes can be used for speeding development and improving process control.

Material properties play a role in container closure integrity under frozen or cryogenic storage temperatures.