BioPharm International

BioPharm International
Share

BioPharm International

 •  September 19

FDA sent a warning letter, dated Sept. 7, 2017, to Wuxi Medical Instrument Factory after an inspection of the company’s No. 43 Xixin Road, Zhangjing, Xibei Town, Wuxi City Jiangsu, China facility, conducted March 6–10, 2017. The warning letter details current good manufacturing practice (CGMP) violations that include deficient validation, batch...

BioPharm International

 •  September 19

The single-cell printer system helps isolate single cells and provide visual documentation to ensure monoclonality for cell line development. On Sep. 19, 2017, Molecular Devices, a provider of high-performance bioanalytical measurement systems, software, and consumables, formed a partnership with Cytena, a start-up life sciences company focused on...

BioPharm International

 •  September 15

On Sep. 12, 2017, Fujifilm Diosynth Biotechnologies, a biologics contract development and manufacturing organization (BioCDMO), announced the opening of its new 10,000-ft2 cell culture Process Development Laboratories in Wilton Centre, Teesside in the United Kingdom. The laboratories were built through a JPY 1-billion (US$9-million) investment,...

BioPharm International

 •  September 15

Bormioli Rocco Pharma, an Italian supplier of glass and plastic packaging, has made its Delta-molded, type 1 glass vials available to the North American market. The vials are available in a range of sizes and capabilities for injectables, including biologics, and offer high hydrolytic resistance and internal surface homogeneity to protect against...

BioPharm International

 •  September 14

On Sept. 5, 2017, Lonza announced a supply agreement with Portola Pharmaceuticals, a biopharmaceutical company specializing in thrombosis and other hematologic diseases, for AndexXa (andexanet alfa), a universal recombinant protein reversal agent for patients on FXa inhibitors who experience a major bleed or need urgent surgery. Under the terms of...

BioPharm International

 •  September 12

In an FDAVoice blog post dated Sept. 11, 2017, Michael Kopcha, PhD, RPh, FDA’s director of the Office of Pharmaceutical Quality, Center for Drug Evaluation and Research (CDER) announced a public docket for comment, open until Sept. 21, 2017, to gather industry input as part of the agency’s support for the use of continuous manufacturing (CM) in...

BioPharm International

 •  September 12

Bayer will use Berkeley Lights’ platform of nanofluidic chips that automate biological workflows, including cell-line development and antibody discovery and engineering. Bayer AG has entered into a strategic project with Berkeley Lights, a company that develops and commercializes platforms for biopharmaceutical, genomic, and cellular therapy...

BioPharm International

 •  September 12

Alexion’s restructuring will reduce its global workforce by 20%, including closing a manufacturing facility in Rhode Island.
Alexion Pharmaceuticals announced an operational plan on Sept. 12, 2017 to realign its global organization with its refocused corporate strategy. The plan is expected to deliver approximately $270 million in GAAP [generally...

BioPharm International

 •  September 12

On Sep. 12, 2017, Riboxx Pharmaceuticals, a German biotech company specializing in the development of toll-like-receptor (TLR) and RIG-I-like-receptor (RLR) ligands, and Accinov, a biomanufacturing center located in Lyon, France, announced the manufacture, including packaging and quality control, of Riboxxim, a potent TLR3-ligand, on an industrial...

BioPharm International

 •  September 8

The biopharmaceutical company broke ground on what will be a new 3000-ft2 addition to its Kansas biomanufacturing facility. On Sep. 6, 2017, Ventria Bioscience, a biopharmaceutical company focused on gastrointestinal, autoimmune and infectious diseases, broke ground at its Junction City, KS, site for an expansion of its biomanufacturing and...