Biopharmaceuticals and Biologics Manufacturing: An In-depth Review
Keywords:
manufacturing, biopharmaceuticals, biologicsAbstract
Biopharmaceuticals and biologics have transformed the therapeutic landscape, offering innovative treatments for various diseases. The production of these complex molecules poses unique challenges due to their intricate structures and biological origins. This review article comprehensively explores the manufacturing processes of biopharmaceuticals and biologics, discussing key production platforms, downstream processing techniques, regulatory considerations, and recent advancements. The article concludes by highlighting the importance of advanced manufacturing strategies for ensuring product quality, affordability, and availability of life-saving biologic therapies.
How to cite this article:
Verma A,Yadav M. Biopharmaceuticals and Biologics Manufacturing: An In-depth Review. Rec Trends Pharm Tech Ind 2023; 5(1): 1-4.
References
Walsh G. Biopharmaceuticals: Biochemistry and Biotechnology. 3rd ed. John Wiley & Sons, 2018;.
Shukla, Arun A, and Jürgen Thömmes. “Recent Advances in Large-Scale Production of Monoclonal Antibodies and Related Proteins.” Trends in Biotechnology 28, no. 5 (2010): 253-261.
Singh, Nidhi, Shweta Arora, and Suresh Kumar Khare. “Recent Advances in Microbial Bioprocessing and Bioproducts.” Critical Reviews in Biotechnology 37, no. 2 (2017): 180-194.
Rathore, Anurag S, and Manisha Pathak. “Advances in Downstream Processing of Monoclonal Antibodies.” Antibodies 2, no. 3 (2013): 403-419.Philpott, Kirk L., and Douglas D. Frey. “Single-Use Technology in Biopharmaceutical Manufacture.” Journal of Chemical Technology and Biotechnology 91, no. 3 (2016): 679-691.
Jagschies, Gunnar, and Eva Lindskog, eds. Continuous= Biopharmaceutical Manufacturing: From Concepts to Processes. Vol. 2. CRC Press, 2019.
Farid, Suzanne S., et al., eds. Bioprocessing of Recombinant Proteins: Bioprocess Technology. Vol. 11. Springer, 2019.
Rader, Ronald A. Commercializing Successful Biopharmaceuticals: Basic Principles. John Wiley & Sons, 2015.
Rathore, Anurag S, and Rucha Bhambure. “Advances in Biopharmaceutical Cell Culture Technology.” Chemical Engineering Science 125 (2015): 45-60.
Kumar Alok, Naveen K Singh, and Dharmendra Setia. “Advances in Plant-Based Biologics for Therapeutic Proteins and Virus-Like Particles.” Bioengineered 11, no. 1 (2020): 416-433.
Jen Fuhong E, and Rituparna Bhattacharya. “Bioprocessing of Therapeutic Proteins from the Inclusion Bodies of Escherichia coli.” Microbial Cell Factories 18, no. 1 (2019): 1-20.
Gottschalk Uwe. “Next Generation Manufacturing Processes for Monoclonal Antibodies.” Trends in Biotechnology 34, no. 11 (2016): 953-960.
Sutradhar Krishna B, and Mohammad L. Amin. “Biopharmaceutics and Pharmacokinetics Considerations in Drug Development.” Pharmaceutical Sciences 19, no. 2 (2013): 117-129.
Li Xudong, and Lawrence Yu. Pharmaceutical Quality by Design: Product and Process Development, Understanding, and Control. Pharmaceutical Research 31, no. 4 (2014): 797-807.
Aggarwal, Shikha. “What’s Fueling the Biotech Engine—2018 to 2019.” Nature Biotechnology 37, no. 5 (2019): 533-537.
Shukla Arun A, and Shweta Gupta. “Regulatory Challenges for Biosimilars.” Nature Biotechnology 28, no. 5 (2010): 436-439.
