Manufacturing, Biologic Drugs

FDA Approves Drug Product Manufacturing for Samsung BioLogics

August 14, 2018

Drug product approval from FDA follows previous approvals from European and Japanese authorities.

FDA Approves First-of-its-Kind RNA Therapy

August 13, 2018

The new drug, Onpattro (patisiran), by Alnylam Pharmaceuticals, is in a new class of drugs called small interfering ribonucleic acid (siRNA) treatment.

Avalon GloboCare Partners with Weill Cornell Medical College for CAR-T Production Technologies

August 08, 2018

Pharmaceutical Technology's In the Lab eNewsletter

Avalon and Weill will co-develop bio-production and standardization procedures for CAR-T therapy.

Regeneron, bluebird bio Partner on Cell Therapy Development

August 06, 2018

The companies will collaborate on the discovery, development, and commercialization of cell therapies for cancer.

Boehringer Ingelheim Licenses Global Rights to Cystic Fibrosis Gene Therapy

August 06, 2018

Boehringer Ingelheim joins Oxford BioMedica, UK Cystic Fibrosis Gene Therapy Consortium, and Imperial Innovations to form a partnership for developing a new gene therapy to treat cystic fibrosis.

Amgen Breaks Ground on Next-Generation Biomanufacturing Plant

August 02, 2018

The company broke ground on its $200-million, 120,000-ft2 biomanufacturing plant in West Greenwich, RI.

Modular Manufacturing Can Ease Bioprocessing Woes

August 02, 2018

Modular manufacturing systems offer a less costly way to increase capacity while reducing time-to-market.

The Challenge of Building Better Biologic Drugs

August 02, 2018

Development costs and time to market continue to put pressure on the biopharma industry, driving the need for innovation in methods and technologies.

CMO Roundup: Expansions for Biomanufacturing

August 01, 2018

CMOs have been active over the past year in expanding their biologics production and capabilities.

Reducing Cleanroom Complexities and Cost

August 01, 2018

Why shouldn’t biopharmaceutical manufacturers be able to leverage standardized construction practices to improve time to market?