BioPharm International

BioPharm International
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BioPharm International

 •  December 13

On Dec. 13, 2017, Samsung BioLogics announced that it received approval from the European Medicines Agency (EMA) for the production of a monoclonal antibody (mAb) drug substance at its second facility in Songdo, Incheon, South Korea. This marks the first mAb that will be produced at the 152,000-L bioproduction facility, according to the...

BioPharm International

 •  December 8

The new 30,000-L, $150-million biologics manufacturing facility in Wuxi, China, quintuples the company’s existing manufacturing capability. WuXi Biologics, a China-based open-access biologics technology platform company, announced on Dec. 6, 2017 that it has started up its new 30,000-L cGMP biologics manufacturing facility in Wuxi, China, and that...

BioPharm International

 •  December 7

An increasing number of warning letters shows that FDA is observing more problems with pharmaceutical contract manufacturing. FDA officials continue to be alarmed about violative production practices and inadquate quality control at drug outsourcers, as seen in a rise in warning letters and citations to contractors and their pharma clients....

BioPharm International

 •  December 6

PharmaForce, a privately held R&D and manufacturing company, announced its $145-million investment to expand two of its Ohio facilities on Dec. 4, 2017. The company will add approximately 140,000 ft2 to its New Albany, OH, facility to expand manufacturing and warehouse operations, as well as remodel a section of its existing warehouse and...

BioPharm International

 •  December 6

On Nov. 30, 2017, AMRI announced that it has expanded its current bulk active pharmaceutical ingredient (API) aseptic manufacturing capacity at its facility in Valladolid, Spain. The Valladolid facility joins the company’s other aseptic API-capable facilities in Bon Encontre and Tonneins, France. “This investment supports our intent to serve our...

BioPharm International

 •  December 5

Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars. On Dec. 4, 2017, a final round of comments from industry stakeholders who raised questions over FDA’s draft guidance, “Statistical Approaches to Evaluate...

BioPharm International

 •  December 5

On Dec. 1, 2017, the European Medicines Agency (EMA) and the European Commission published updated guidance for pharmaceutical companies regarding the United Kingdom’s withdrawal from the European Union. The new guidance answers additional questions about marketing applications and authorizations. New in this update is more information on batch...

BioPharm International

 •  December 4

FDA has approved Mylan’s Ogivri (trastuzumab-dkst), a biosimilar to Roche’s Herceptin (trastuzumab), for treating breast or metastatic stomach cancer in patients whose tumors overexpress the HER2 gene (HER2+), the agency announced on Dec. 1, 2017. Ogivri is the first biosimilar approved in the United States for treating breast and stomach cancers...

BioPharm International

 •  December 4

The acquisition deepens Astellas’ involvement in the development of a pipeline of therapeutics focused on mitochondrial function. On Nov. 30, 2017, Astellas Pharma announced that it acquired Mitobridge, a US-based biotech start-up focused on discovering and developing small-molecule therapeutics that enhance mitochondrial function, in a deal worth...

BioPharm International

 •  December 1

In a recently released statement, FDA Commissioner Scott Gottlieb warned of an amino acids supply shortage and gave an update on a saline supply shortage, both due to the impact of hurricanes on Puerto Rican manufacturing facilities. On Nov. 30, 2017, FDA Commissioner Scott Gottlieb released a statement warning of a supply shortage of amino acids...