Quality Controls and Quality Assurance Systems Employed in Downstream Bioprocessing

A STUDY OF THE MAIN QUALITY CONTROLS AND QUALITY ASSURANCE SYSTEMS TYPICALLY EMPLOYED IN DOWNSTREAM BIOPROCESSING TO ENSURE THE MANUFACTURE OF HIGH-QUALITY PROTEIN PRODUCTS ON A CONSISTENT BASIS
Name
I declare that this project is solely the work of the author and is submitted in partial fulfillment of the requirements of the module ‘Fermentation and Cell Culture Processing’.
Abstract
Downstream processing is applied in protein processes to separate, purify, and distillate the previously manufactured drug substance, in this case, protein products, from the intricate bulk matrix. This research paper conducted a systematic review of the main quality controls and quality assurance systems typically employed in downstream bioprocessing to consistently manufacture high-quality protein products. Secondary research entailed identifying and assessing relevant data sources on quality control checks during isolation, purification, concentration, and formulation activities, representing the transition from protein-engineered biocatalysts to therapeutic enzymes ready for human administration. After comparing and analyzing various data sources, the research paper determined that quality control methods are mainly categorized into analytical methods related to purity, identity, safety, strength, and potency of the medicinal product. The study further revealed that each of the five quality control categories entails specific measurements recommended by good manufacturing practices and regulatory bodies. Although most studies determined a strong emphasis on quality control and quality assurance issues from a manufacturing perspective, other critical facets of production, including people, equipment, and manufacturing facilities, tended to be largely ignored.
Acknowledgments
I appreciate the assistance given to me by my tutors and peers. I am also grateful for the words of support and encouragement from family and friends.
Contents
1.0 Abstract………………….……………………………………………….......……………II
2.0 Acknowledgements……………………………………………………..……..........……..III
3.0 Contents…………………………………………………………………………..………..IV
4.0 Introduction…………………………………………………………………...…....……….1
5.0 Literature Review………………………………………………………………...…………2
4.1 Quality Control and Qual...