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Impact of process validation and equipment qualification in production of bio-therapeutics

Goutam Ghosh, Rabi Prasad Bodroth, Basabjit Dutta.


Production of therapeutic proteins like Biosimilars uses a complex cell based fermentation and purification process. There are chances of errors in these complex production processes due to complexities in the molecular pathway that every protein follows. Therefore to produce a desired therapeutic protein that elicit the correct immunological response in the patient, one need to ensure that it must have correct sequence, size, structure so that they are recognized by the specific receptors. The quality of these therapeutic proteins are characterized through standard assays and methods such as SDS PAGE (sodium dodecyl sulphate–polyacrylamide gel electrophoresis), IEF (Isoelectric Focusing), Western Blot and other methods those are based on HPLC, Mass Spectrometry and Capillary Electrophoresis to conform the desired molecular size, purity and identity of proteins. Thus in the process of validation of a method, equipment plays a critical role in ensuring the quality and safety of a biopharmaceutical product. It is always necessary to generate scientific data and information such as IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Performance Qualification) protocol and reports for each instrument employed in the process at the beginning and before the actual testing of the desired product. It is only after the completion of these activities, the product under different manufacturing steps can be characterized. Involvement of a software in conjunction to an equipment is also common and it is important that the software is in use with the equipment also meets the requirements of the CFR 21 FDA (Code of Federal Regulations, 21 Part 11 of US Food and Drug Administration), which is a legal requirement in a modern manufacturing process and hence it is important to comply with these rules as set of guidelines that will help ensure the integrity and safety of data.

Key words: Therapeutic Protein, Equipment Validation, Installation Qualification, Design Qualification, Operational Qualification, Performance Qualification.

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