Development

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The new draft guidance addresses the premarketing assessment of a drug’s effect on blood pressure.

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

The FDA commissioner released a statement expressing the agency’s plan to address tactics used by pharma companies to delay generic-drug competition.

Valerius Biopharma will use Catalent’s GPEx technology to produce cell lines for biosimilar drugs.

Smaller review divisions will bring experts closer to decision processes and reduce bottlenecks, FDA leaders say.

A validation plan developed to support a process unrelated to bio- pharmaceutical manufacture is applied to bio- pharmaceutical processes and systems.

While technology promises advances for healthcare, a skilled workforce is needed to deliver on the potential.

More published data and initial regulatory approvals are needed to drive adoption of continuous bio-manufacturing.

Process understanding and careful assessment of risks are essential in developing viral clearance programs.

Scientists at Washington University School of Medicine in St. Louis have developed a new method that could help increase the long-term effectiveness of gene therapy.

Research from Gladstone Institutes suggests that transplanting genetically altered interneurons could improve cognitive function for Alzheimer’s disease.

The new platform is expected to speed up cell line development.

LNC Therapeutics has appointed a new CEO and is strengthening its R&D for gut microbiome-based drugs.

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

The company is launching a new pre-fabricated, ready-to-run manufacturing facility that is expected to significantly decrease the production timeline for viral vector-based therapeutics.

Kemiex trading network is designed to increase safety in the sourcing of APIs and additives.

Roche has acquired a program to develop regenerative therapies for multiple sclerosis.

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

National Institutes of Health researchers use genomics to show that squamous cell carcinomas differ from other cancers, which could advance treatments for head and neck and other cancers.

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

On Tuesday, April 24, 2018, Evan Boswell, senior principal scientist at Pfizer CentreOne Contract Manufacturing, Pfizer CentreOne will give a presentation on scaling up the manufacturing process of active pharmaceutical ingredients at CPhI North America in Philadelphia, PA.

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

Access to multiple analytical techniques is essential for fully characterizing complex protein formulations.

This is the first of a series of three articles about validation and technical transfer in the bio- pharmaceutical industry.