Manufacturing

Articles

The company has run into a snag in producing Kymriah for the diffuse large B-cell lymphoma patient population, the second indication for which the therapy was recently approved by FDA.

Novartis Has Production Hiccup for Kymriah CAR-T Therapy

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Modern technologies, including Industry 4.0 and the Industrial Internet of Things, offer opportunities to increase biopharmaceutical manufacturing efficiency.

Industry 4.0 in Biopharmaceutical Manufacturing

CELLforCURE will produce cancer CAR-T treatments for Novartis at a manufacturing facility in Les Ulis (Essonne), France.

Novartis, CELLforCURE Partner to Manufacture CAR-T Therapies

The media, by Tosoh Bioscience, is composed of calcium and phosphate buffers and offers mixed-mode properties for biomolecule purification.

Hydroxyapatite Chromotography Media Offers Enhanced Biomolecule Purification

Moderna’s new manufacturing plant in Norwood, MA gives the company capacity for preclinical and Phase I and II clinical manufacturing for its mRNA development candidates, including personalized cancer vaccines.

Moderna Opens Manufacturing Site for mRNA Therapeutics

The agency is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.

FDA Commissioner Gottlieb Releases Statement on Advancement of Gene Therapies

Report predicts PAT, NIRS, continuous bioprocessing, and a ‘technological arms race’ could improve biopharma manufacturing efficiencies.

Cross-Industry Expertise Can Promote Manufacturing Improvements

The acquisition of Flex Concepts adds custom, single-use products to Entegris’ single-use bag product line. 

Entegris Acquires Flex Concepts

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Biopharma seeks alternatives that meet the needs for next-gen biologic drug production.

The Search for Next-Gen Expression Systems

Ronald A. Rader is senior director, Technical Research, at BioPlan Associates.

Eric Langer has over 25 years experience in biotechnology and life sciences strategic marketing management, market research, and publishing. He has held senior management and marketing positions at biopharmaceutical supply companies. He has published and authored many books and reports on topics in Biotechnology, Large-scale BioManufacturing, and bioscience commercialization and communication. He teaches at Johns Hopkins University marketing management, biotech marketing, services marketing, and marketing in a regulated environment. In 1989 he co-founded BioPlan Associates, Inc. to provide market analysis, and strategy to biotech and healthcare organizations.

This article highlights 15 years of changes in biopharmaceutical manufacturing.

Manufacturing, Biologic Drugs