Biologic Drugs

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

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

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

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

This article highlights 15 years of changes in biopharmaceutical manufacturing.

FDA seeks more efficient testing to spur development of less costly biotech therapies.

Macromolecular drugs are typically injected, but oral dosage forms are being developed to improve the treatment of gastrointestinal conditions such as inflammatory bowel disease.

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.

The three-year collaboration will focus on developing vaccines for up to five infectious disease pathogens.

The contract development and manufacturing company has received an additional approval from Health Canada to manufacture monoclonal antibody drug substance at its first plant in Icheon, South Korea.

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

A new report released at the BIO International Convention shows that the US bioscience industry has had a $2-trillion economic impact and has accelerated venture capital investment and job growth.

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

The agency has recommended approval of three biosimilar adalimumab products from Novartis, referencing AbbVie’s Humira, and a biosimilar trastuzumab from Pfizer, referencing Roche’s Herceptin.

EMA has recommended marketing authorization for Aimovig (erenumab), a new treatment for migraine.

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

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

In adding a Vanrx Pharmasystems aseptic filling isolator, FUJIFILM adds fill/finish for gene therapies and viral vaccines.

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

The company is increasing its cell culture media production capacity at its facilities in Pasching, Austria, and Logan, Utah.

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

Understanding the advantages and suitability of different methods to measure residual moisture content in lyophilized materials--and the respective limitations--aids in selecting the most appropriate method for testing.

Naturally occurring and engineered albumins are being explored as a tool to enhance the stability of drugs, including biologics, and extend shelf-life.

A skilled workforce is needed to deliver on technology’s promising medical advances.

Bioprocess understanding, the right equipment, and automation help, but multifunctional teamwork is the key to API production success.

After a review of public comments, USP will not move forward with nomenclature proposal without further FDA collaboration.

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

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

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