Manufacturing

The company is certified as a manufacturer of pressure vessels and components for use in China.

The new Testa Center in Uppsala, Sweden is a collaborative test bed offering biotechnology equipment from GE Healthcare for process development.

Dompé Farmaceutici’s Oxervate (cenegermin), a topical eye drop, is the first treatment approved by the agency for neurotrophic keratitis, a rare disease affecting the cornea.

FDA grants support US research in continuous manufacturing monitoring and control techniques for bio/pharmaceutical manufacturing at Rutgers, MIT, and Georgia Tech.

Pharmaceutical scientist association announces upcoming term’s board of directors.

The new drug, Onpattro (patisiran), by Alnylam Pharmaceuticals, is in a new class of drugs called small interfering ribonucleic acid (siRNA) treatment.

The agency issued a warning letter to Canadian API manufacturer, Les Produits Chimiques B.G.R, citing cGMP violations at its API facility in Pointe-Claire, Quebec.

The combined companies will provide research- and clinical-grade human immune cells, blood products, and related services.

Avalon and Weill will co-develop bio-production and standardization procedures for CAR-T therapy.

The companies will collaborate on the discovery, development, and commercialization of cell therapies for cancer.

Boehringer Ingelheim joins Oxford BioMedica, UK Cystic Fibrosis Gene Therapy Consortium, and Imperial Innovations to form a partnership for developing a new gene therapy to treat cystic fibrosis.

AuroMedics Pharma issued a voluntary, nationwide recall of two lots of piperacillin and tazobactam for injection, USP 3.375 g due to the presence of particulates identified as glass and silicone material.

The company broke ground on its $200-million, 120,000-ft2 biomanufacturing plant in West Greenwich, RI.

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

The companies will work together to develop novel gamma delta T-cell receptor therapies in various cancers.

The changing regulatory and manufacturing environment is ushering in a new approach to drug development.

The quality of the cell lines used to manufacture biopharmaceuticals are crucial for the production of high-quality, stable biopharmaceuticals.

Pfizer will invest nearly half a billion dollars to build a sterile injectable facility in Michigan.

The acquisition would combine Sangamo’s ex vivo gene-editing capabilities with TxCell's regulatory T-cell (Treg) expertise to create chimeric antigen receptor (CAR)-Treg therapies.

The company has run into a snag in producing Kymriah for the diffuse large B-cell lymphoma patient population, the second indication for which the therapy was recently approved by FDA.

The media, by Tosoh Bioscience, is composed of calcium and phosphate buffers and offers mixed-mode properties for biomolecule purification.

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

Moderna’s new manufacturing plant in Norwood, MA gives the company capacity for preclinical and Phase I and II clinical manufacturing for its mRNA development candidates, including personalized cancer vaccines.

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

Catalent Biologics will adopt Berkeley Lights’ Beacon optofluidic platform for its cell-line development workflow.