APIs and Excipients

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.

Selecting Excipients for Controlled Release

July 02, 2018

With the right excipients, formulators can control when, where, and how an API is released.

Minakem Opens New High Containment Facility

June 25, 2018

Minakem’s facility in Belgium enhances capacity to scale production of highly potent ingredients for small to full GMP batches.

CellGenix Completes First Step of Facility Expansion for Cell-Culture Reagents

June 22, 2018

The company has completed the first phase of expansion at its headquarters in Freiburg, Germany, in anticipation of increasing demand as cell and gene therapies approach commercialization.