“But why are they calling these products ‘drugs?’” I asked at the recent CMC Strategy meeting that CaSSS hosted in Gaithersburg. “Well it’s because they aren’t vaccines or blood products” said an old friend, who is an authority in the field. “But,” I said, “we’re really talking about therapeutic glyco-proteins produced by living organisms.” And just to make sure I was remembering things correctly, I searched Google and reviewed the definitions for a “biologic” and “biological” in several of the top technical references. Truly, a biologic or biological is a substance produced by a living organism, which would include glyco-proteins, non-glycosylated proteins, enzymes, viruses, and broken up proteins which could be used as poly-peptides or simple antigens…
Tag: <span>biotherapeutics</span>
Safety is typically viewed, perhaps unconsciously, as the result of a collection of factors, conditions, or behaviors. For example, consider “safety” in the context of personal, financial, or travel. With each, safety is defined as a set of component risks that have been managed to satisfactory levels for a particular situation. The same is true for product safety and risk, whether it be for raw materials or finished goods. The “safe” use of fetal bovine serum (FBS) is achieved by the management of controllable risks to a level that is acceptable for each particular application. For example, risk reduction requirements for research applications are not as stringent as for diagnostic, therapeutic, or manufacturing applications. Each end-user must decide on the level of risk reduction that is appropriate for their application…
For over 80 years, fetal bovine serum (FBS) and other animal-derived materials have been widely used in the production of vaccines, and more recently, biotherapeutics, for both human and animal applications. Ever since FBS was initially developed as a cell culture reagent, there have been efforts made to avoid the use of this critical commodity. The International Serum Industry Association (ISIA) recognizes the requirement for robust risk assessment and management, and has several ongoing programs designed to help mitigate the risk of using animal-derived materials. This article will provide an outline of the state of the industry and of these programs…