Biotechno logical

ICH Q6B. Specifications Test Procedures and Acceptance Criteria for Biotechno-logical/Biological Products, August 1999. 

Q5C Quality of Biotechnological Products Stability Testing of Biotechno-logical/Biological Products. 

Immunogenicity has attracted enormous attention recently, and this will be a key decision point for competitors to evaluate whether their molecule meets the criteria, or not. With regard to the reactions that may occur in products that are biotechno-logically driven, these results are not clearly understood. For example, changes in the manufacturing process may alter the nature of the finished product and trigger an immune response. A noteworthy case of this was centered on Johnson Johnson s EPO product which is currently marketed under the brand-name Eprex . 

Biotechno- logical process (line) Unit equipment Unit operations... 

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