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In 1996, CBER (Center for Biologics Evalution & Research) established that certain categories of highly characterized biologicals or the concept of "well characterized biologicals", would require only the submission of a single Biological License Application (BLA) for product marketing, rather than the previous, dual Product License Application/ Establishment License Application (PLA/ELA).
In 1998, the FDA began allowing analytical testing to support manufacturing changes, which in many cases eliminated the need to repeat costly clinical trials when equivalent biocomparability could be demonstrated. This was made possible through the advances in the techniques and methods available for analyzing biotechnology products.
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The development of analytical methods is a critically important component in the development and manufacture of biopharmaceutical products. A wide range of techniques is required to characterize the product and to support studies to evaluate product stability, process and product consistency and repetitive equivalence studies following process changes.
Analytical methods used to evaluate the following properties and to establish a "Well Characterized Biological" include:
- Identity - the primary and secondary structure, any post-translation modifications such as glycosylation, phosphorylation and deamidation
- Purity - aggregates/degradation products, any contaminating host cell proteins
- Potency - the quantity of active produce in bulk biopharmaceutical substance and final formulated product
- Stability - has been stressed and undergone real-time testing
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