APIs and Excipients

New Tools Outline Advances for Continuous API Processing

June 02, 2018

From separation systems to reactor technology, new tools are increasing the feasibility of continuous API production.

Anti-methamphetamine Antibody Moves to Clinic

June 01, 2018

Catalent’s GPEx technology was used to develop antibody for anti-methamphetamine clinical study.

Lonza to Manufacture TxCell Product

June 01, 2018

TxCell announces manufacturing agreement with Lonza for its HLA-A2 CAR-Treg cellular product.

Cambrex Adds Process Development Capabilities

June 01, 2018

Cambrex invests $5 million in new laboratory expansion at its Karlskoga, Sweden facility.

GE and CCRM Partner with DiscGenics on New Cell Therapy

May 30, 2018

GE Healthcare and the Centre for Commercialization of Regenerative Medicine (CCRM) will support scale-up efforts by DiscGenics for a new cell therapy intended to treat back pain.

Samsung BioLogics Receives FDA Approval for Biologic Drug Substance Manufacturing

May 29, 2018

This marks the third FDA approval for the company’s second biomanufacturing plant in Incheon, Korea.

Novartis Gains EC Approval for Infliximab Biosimilar

May 29, 2018

The European Commission has approved Zessly (infliximab), a biosimilar to Johnson & Johnson’s blockbuster Remicade (infliximab).

Novartis’ AveXis to Invest $55 Million in New Gene Therapy Manufacturing Facility

May 25, 2018

The gene therapy company is expected to invest $55 million in a new manufacturing facility that will produce therapies for rare neurological genetic diseases.

Vectalys, FlashCell Merge to Form Gene Therapy Company

May 23, 2018

The new company will develop proprietary RNA-based therapeutics and will provide broad lentiviral development and manufacturing expertise and support.

Cambrex Reports Expansions at its High Point, NC Facility

May 16, 2018

Cambrex Corporation has announced facility, equipment, and instrument upgrades at its High Point, NC facility and updated progress on expansions in Cedar City, IA.