APIs and Excipients

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.

Novartis, CELLforCURE Partner to Manufacture CAR-T Therapies

July 18, 2018

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

Hydroxyapatite Chromotography Media Offers Enhanced Biomolecule Purification

July 18, 2018

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

EU and Japan Strengthen Collaboration on GMP Inspection

July 18, 2018

Both parties have agreed to recognize each other’s inspection of manufacturing sites for a broader range of medicines, including sterile products, APIs, biologics, and vaccines.

FDA Commissioner Gottlieb Releases Statement on Advancement of Gene Therapies

July 12, 2018

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

Cross-Industry Expertise Can Promote Manufacturing Improvements

July 09, 2018

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

Be Quick, But Don’t Hurry

July 02, 2018

After 30 years of biologic-drug advances, the industry and patients still have a lot to learn.

The Search for Next-Gen Expression Systems

July 02, 2018

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