Biologics Development and Manufacturing: Research Cell Bank

Voiceover

Presenter(s)

Jimmy Tangchittsumran

Abstract or Description

Protein biologics are an integral component of biomedical technology and treatments available to patients worldwide. The process by which a human pharmaceutical drug proceeds forward from a research lab to a phase I clinical trial is intricate and requires strict adherence to U.S. Food and Drug Administration (FDA) guidelines. Frequently, it is necessary to develop an upscaled process which is feasible for clinical trials. The mission of the Gates Biomanufacturing Facility (GBF) is “to accelerate the translation of scientific discoveries into human clinical trials as safely, efficiently, and cost effectively as possible according to high quality standards” [2]. For the GBF to produce pharmaceutical quality products, it must adhere to Current Good Manufacturing Practice (cGMP) regulations by the U.S. FDA as applied to human pharmaceuticals. Therefore, a solid foundation on Good Laboratory Practice (GLP), laboratory safety, sterile technique, and ISO Clean Room procedures are vital to daily operations. An active project within the Biologics Development and Manufacturing department, is development of a therapeutic drug. This project involved technical steps including media and buffer preparation, expressing proteins through fermentation, cell lysis, purification through multiple chromatography steps, and formulation by tangential flow filtration. After the product is manufactured, analytical assays are required by Title 21 of the U.S. FDA Code of Federal Regulations to show potency, identity, safety, and purity. A subset of this project included generation of a research cell bank utilized to generate a master cell bank for production of cGMP grade protein biologics suitable for animal toxicology studies and human clinical trials.