Generic Pharmaceutical Association's workshop on regulatory and legislative issues hears industry views on characterisation of active pharmaceutical ingredients
Microbix Biosystems will offer industry perspective on biotechnology-derived active pharmaceutical ingredients during a workshop of the Generic Pharmaceutical Association (GPhA) being held in Manhattan.
The GPhA workshop 'Current Regulatory and Legislative Issues for API Manufacturers' is taking place during the Drug, Chemical and Allied Trades Association Week in New York.
Ken Hughes, vice president of scientific affairs for Microbix, will present to the forum and discuss current industry views on the characterisation of active pharmaceutical ingredients used in generic biotechnology drug products (generic biologics), with particular emphasis on generic urokinase. "Microbix's urokinase product is seen by opinion leaders in the United States as being at the forefront of this emerging business opportunity, which is of great interest to the generic pharmaceutical industry," said William J Gastle, president and CEO of Microbix.
Dr Hughes will be a panellist with Steve Bende, vice president science, professional and regulatory affairs for the GPhA, and Roger Williams, executive vice president and CEO of the United States Pharmacopeia.
Dr Bende's technical division serves as the vital link between the science of pharmaceuticals and the public policy positions supported by the GPhA.
The USP is a non-government organisation that promotes public health by establishing state-of-the-art standards to ensure the quality of medicines and other health care technologies.
The standards are developed by a unique process of public involvement and are recognised worldwide. Microbix specialises in developing and manufacturing tissue culture-derived biologicals for an emerging world market for biotherapeutic drugs and vaccines.
It makes reagents for building diagnostic products and tools used in biotechnology research.
