BRUSSELS, Belgium - A new guideline on test procedures and acceptance criteria for biotechnology products has emerged from the European Medicines Evaluation Agency (EMEA), in London - the body that provides the scientific input for European Union authorization decisions on new biotechnology products.
The guideline has been put out for consultation in Europe, with a deadline for comments in July.
The objective of the guideline is to provide general principles on the establishment and justification of a uniform set of international specifications for biotechnological and biological products to support new marketing applications.
The proposal stated the characterization of a biotechnological or biological product should include the determination of physicochemical properties, biological activity, immunochemical properties, purity and impurities.
The characterization is necessary, the EMEA said, to allow relevant specifications to be established. Acceptance criteria should be established and justified based on data obtained from lots used in preclinical and clinical studies, data from lots used for demonstration of manufacturing consistency, and relevant development data, such as those arising from analytical procedures and stability studies. - Peter O'Donnell