Cell and Gene Therapies and Their GMP Requirements

Cover: Cell and gene therapies are the latest revolution in medicine manufacturing. Unlike small molecules or traditional biotech products, these therapies introduce cells and genes into a patient to treat the underlying cause of a disease—they are living medicines. This article provides an overview of key considerations for manufacturers of cell and gene therapies.

The Next Wave in Biopharma Manufacturing

Features: Innovations in production methods and technologies that enable a competitive and sustainable biopharmaceutical product supply were the focus of presentations at the 2019 ISPE Biopharmaceutical Manufacturing Conference in Boston, Massachusetts, 18–20 June. Future directions for the biopharma manufacturing industry were well represented by speakers from a range of environments.

Practical Regulatory and Industry Issues

Features: Presenters and a panel of FDA regulators and industry experts discussed key regulatory and industry issues during the closing plenary of the 2019 ISPE Biopharmaceutical Manufacturing Conference.

Industrializing New Platforms

Features: Moving platforms from development to the delivery of more biopharmaceuticals to more patients is reality, not just a concept, for Moderna, Inc. Juan Andres, the company’s Chief Technical Operations and Quality Officer, presented on “mRNA Medicines—Industrializing a New Platform” at the 2019 ISPE Biopharmaceutical Manufacturing Conference, sharing information about groundbreaking work underway at Moderna.