Evolving Paradigms of Recombinant Protein Production in Pharmaceutical Industry: A Rigorous Review
Achuth Jayakrishnan,
Wan Rosalina Wan Rosli,
Ahmad Rashidi Mohd Tahir,
Fashli Syafiq Abd Razak,
Phei Er Kee,
Hui Suan Ng,
Yik-Ling Chew,
Siew-Keah Lee,
Mahenthiran Ramasamy,
Ching Siang Tan,
Kai Bin Liew
Affiliations
Achuth Jayakrishnan
Department of Microbiology, Hindusthan College of Arts and Science, Coimbatore 641028, India
Wan Rosalina Wan Rosli
Faculty of Pharmacy, University of Cyberjaya, Persiaran Bestari, Cyberjaya 63000, Malaysia
Ahmad Rashidi Mohd Tahir
Faculty of Pharmacy, University of Cyberjaya, Persiaran Bestari, Cyberjaya 63000, Malaysia
Fashli Syafiq Abd Razak
Faculty of Pharmacy, University of Cyberjaya, Persiaran Bestari, Cyberjaya 63000, Malaysia
Phei Er Kee
Biorefinery and Bioprocessing Engineering Laboratory, Department of Chemical Engineering and Materials Science, Yuan Ze University, Chungli, Taoyuan 320, Taiwan
Hui Suan Ng
UCSI-Cheras Low Carbon Innovation Hub Research Consortium, UCSI University, Kuala Lumpur 56000, Malaysia
Yik-Ling Chew
Faculty of Pharmaceutical Sciences, UCSI University, Kuala Lumpur 56000, Malaysia
Siew-Keah Lee
M. Kandiah Faculty of Medicine and Health Sciences, Universiti Tunku Abdul Rahman, Jalan Sungai Long, Bandar Sungai Long, Kajang 43000, Malaysia
Mahenthiran Ramasamy
Department of Microbiology, Dr. N.G.P. Arts and Science College, Coimbatore 641048, India
Ching Siang Tan
School of Pharmacy, KPJ Healthcare University, Lot PT 17010 PersiaranSeriemas, Kota Seriemas, Nilai 71800, Malaysia
Kai Bin Liew
Faculty of Pharmacy, University of Cyberjaya, Persiaran Bestari, Cyberjaya 63000, Malaysia
Many beneficial proteins have limited natural availability, which often restricts their supply and thereby reduces their potential for therapeutic or industrial usage. The advent of recombinant DNA (rDNA) technology enables the utilization of different microbes as surrogate hosts to facilitate the production of these proteins. This microbial technology continues to evolve and integrate with modern innovations to develop more effective approaches for increasing the production of recombinant biopharmaceuticals. These strategies encompass fermentation technology, metabolic engineering, the deployment of strong promoters, novel vector elements such as inducers and enhancers, protein tags, secretion signals, synthetic biology, high-throughput devices for cloning, and process screening. This appraisal commences with a general overview regarding the manufacture of recombinant proteins by microbes and the production of biopharmaceuticals, their trends towards the development of biopharmaceuticals, and then discusses the approaches adopted for accomplishing this. The design of the upstream process, which also involves host selection, vector design, and promoter design, is a crucial component of production strategies. On the other hand, the downstream process focuses on extraction and purification techniques. Additionally, the review covers the most modern tools and resources, methods for overcoming low expression, the cost of producing biopharmaceuticals in microbes, and readily available recombinant protein products.