Biologic Drugs in Development

Colin Clarke, from the National Institute for Bioprocessing Research and Training, will lead a four-year European Industrial Doctoral Program for enhancing upstream biopharmaceutical manufacturing process development through single cell analysis.

Andrew Bulpin, head of Process Solutions, MilliporeSigma, shares insights on characterizing CQAs in biopharmaceutical development and the different tests that should be carried out when assessing an investigational drug.

Protagen Protein Services, a CRO, now offers quicker and more accurate characterization of biomolecular stability using differential scanning calorimetry (DSC).

Frustrated by slow market adoption, Gottlieb maps out new plan for biosimilar competition.

The National Science Foundation grant will be used to commercialize a synthetic biology platform for cancer drug development.

In launching FDA’s Biosimilar Action Plan, Gottlieb takes innovator companies to task for delaying competitive biosimilar products.

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

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

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

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.

MilliporeSigma targets emerging biotechs with US development center and global grants.

The company will provide the first FlexFactory manufacturing platform for cell therapy manufacturing.

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

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.

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

The agency has granted breakthrough therapy designation to Roche’s hemophilia therapy for treating hemophilia A in patients without factor VIII inhibitors.

Johnson & Johnson’s Janssen partners with Bristol-Myers Squibb to advance next-generation therapies for cardiovascular diseases.

Under this global collaboration, the companies will develop encapsulated cell therapies for treating Type 1 diabetes.

Boehringer Ingelheim and OSE Immunotherapeutics have entered a global immuno-oncology partnership to develop a checkpoint inhibitor for treating advanced solid tumors.

The companies have created Syna Therapeutics, a joint venture that will develop biosimilars and new molecules.

Pfizer transfers CAR-T assets to Allogene Therapeutics under a new alliance to further develop immuno-oncology therapeutics.

More diversified therapies and tighter payer budgets will challenge bio/pharma companies to think outside the industry.

The companies will co-develop and co-promote a CAR T cell therapy in the United States.

Hitachi will manufacture regenerative medicines developed by Daiichi Sankyo and SanBio Group.

The collaboration between the two companies aims to finish all necessary work needed to file for a first-in-human study by early 2019.