APIs and Excipients

Leistritz Expands NJ Laboratory

August 27, 2018

The company installed a ZSE-3D twin screw extrusion system at its Somerville, NJ process laboratory.

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.

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.

Increasing API Complexity Drives Demand for Cryogenic Capabilities

August 02, 2018

Low-temperature chemistry enables performance of more challenging and selective chemistry.

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.

Classifying Potent and Highly Potent Molecules

August 01, 2018

Determining how much containment is needed for API handling requires evaluation of multiple factors.

CMO Roundup: Expansions for Biomanufacturing

August 01, 2018

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

Cambrex to Acquire Halo Pharma for $425 Million

July 23, 2018

The acquisition will place Cambrex into the finished dosage form CDMO market.

Novartis Has Production Hiccup for Kymriah CAR-T Therapy

July 19, 2018

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.