Cedarburg Hauser Pharmaceuticals has expanded its Wisconsin API plant by 50% to meet commercial demand. The company has also added reactor and chiller capacity for GMP cryogenic reactions, made improvements to the air handling systems, installed a reverse osmosis water system, improved isolation capabilities, and upgraded their Emerson DeltaV Digital Automation System.
Cedarburg Hauser Pharmaceuticals
Thursday, 27 September 2012
CHP adds capacity
Tuesday, 25 September 2012
Thursday, 20 September 2012
Wednesday, 19 September 2012
Wednesday, 12 September 2012
Tuesday, 11 September 2012
Navidea blames manufacturer
Navidea Biopharmaceuticals attributed the Complete Response Letter from the US Food and Drug Administration regarding its NDA for Lymphoseek to issues with third-party contract manufacturers. In November 2009, Navidea appointed Reliable Biopharmaceutical Corporation for the manufacture and supply of the API for Lymphoseek. Final product manufacturing including final drug formulation, lyophilization and packaging processes for Lymphoseek is performed by OSO BioPharmaceuticals Manufacturing LLC.
Reuters
Boehringer Ingelheim implements disposable biomanufacturing
Boehringer Ingelheim has implemented single-use biomanufacturing at its mammalian facilities worldwide. The system can incorporate different commercially available single-use systems in 100L and 500L GMP facilities for clinical material supplies or for non-GMP process development.
Biopharmaceutical Business Review
Monday, 10 September 2012
Cambridge Major to add capacity
Cambridge Major Laboratories is to expand its large scale API manufacturing facility in Germantown, WI, as a result of growth in demand. The company will add reactor capacity and isolation equipment. Brian Scanlan, President & CEO of Cambridge Major, said that the company's "invest in the West" policy continues to bear fruit. He added that the company is "very well positioned to support both increasing demand for our commercial products as well as our healthy pipeline of API's in later phases of clinical development."
Milwaukee Business Journal
Tuesday, 4 September 2012
Aesica Partners with University of Bradford
Aesica has partnered with the Centre for Pharmaceutical Engineering Science at the University of Bradford. Aesica will benefit from the University's research facilities and the University will gain access to Aesica's GMP manufacturing facilities.
Manufacturing Chemist