Biomanufacturing for a Sustainable Future: Unleashing the Potential of Biotechnology in Pharmaceutical Raw Material Production

Authors

  • Marzieh Shokoohi Department of Life Sciences Engineering, Faculty of New Sciences & Technologies, University of Tehran, Tehran, Iran
  • Tahereh Attar School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran

DOI:

https://doi.org/10.63053/ijhes.81

Keywords:

Pharmaceutical raw materials, Recombinant DNA technology, Microbial fermentation, Biocatalysis, Cell culture technology

Abstract

The pharmaceutical industry relies heavily on raw materials for drug development, with Active Pharmaceutical Ingredients (APIs) and excipients forming the fundamental components of pharmaceutical formulations. Traditional methods of pharmaceutical raw material production are plagued by inefficiencies, environmental concerns, and limitations in producing complex molecules. In contrast, biotechnology offers a promising alternative with its capacity for efficient, sustainable, and precise synthesis of pharmaceutical raw materials. This article explores the potential of biotechnology in pharmaceutical raw material production, focusing on techniques such as recombinant DNA technology, microbial fermentation, biocatalysis, and cell culture technology. These methods enable the production of complex molecules with high specificity, purity, and scalability, addressing the shortcomings of traditional approaches. Furthermore, biotechnology facilitates the development of novel drugs, personalized medicine strategies, and innovative treatments, offering hope for previously untreatable conditions. Despite the transformative potential of biotechnology, challenges such as high initial investment, regulatory considerations, and safety concerns need to be addressed for its widespread adoption. In conclusion, embracing biotechnology represents a paradigm shift in pharmaceutical production, promising a more sustainable, personalized, and effective healthcare future. Collaboration between stakeholders is essential to navigate challenges and ensure the responsible advancement of biotechnological applications in healthcare, ultimately improving the quality of life for millions worldwide

References

Kh, Ulaan-Od, and Baoyintu Bai. "The study regarding pharmaceutical raw material of animal derived medicine in “Ocean of medicine names”." Mongolian Medical Sciences (2022): 33-37.‏

Bharate, Sonali S., Sandip B. Bharate, and Amrita N. Bajaj. "Interactions and incompatibilities of pharmaceutical excipients with active pharmaceutical ingredients: a comprehensive review." Journal of Excipients and Food Chemicals 1.3 (2016).‏

Lu, Jie, and Sohrab Rohani. "Polymorphism and crystallization of active pharmaceutical ingredients (APIs)." Current Medicinal Chemistry 16.7 (2009): 884-905.‏

Chaudhari, Shilpa P., and Pradeep S. Patil. "Pharmaceutical excipients: a review." Int J Adv Pharm Biol Chem 1.1 (2012): 21-34.‏

Phillips, Daniel J., et al. "Overcoming sink limitations in dissolution testing: a review of traditional methods and the potential utility of biphasic systems." Journal of Pharmacy and Pharmacology 64.11 (2012): 1549-1559.‏

Castiello, Carola, et al. "GreenMedChem: the challenge in the next decade toward eco-friendly compounds and processes in drug design." Green Chemistry 25.6 (2023): 2109-2169.‏

Sethi, Nilay, and Yibin Kang. "Unravelling the complexity of metastasis—molecular understanding and targeted therapies." Nature Reviews Cancer 11.10 (2011): 735-748.‏

Gurnani, N., et al. "Natural products: source of potential drugs." Afr J Basic Appl Sci 6.6 (2014): 171-186.‏

Salgueiro, L., A. P. Martins, and H. Correia. "Raw materials: the importance of quality and safety. A review." Flavour and Fragrance Journal 25.5 (2010): 253-271.‏

Gavrilescu, Maria, and Yusuf Chisti. "Biotechnology—a sustainable alternative for chemical industry." Biotechnology advances 23.7-8 (2005): 471-499.‏

Walsh, Gary. "Pharmaceutical biotechnology: concepts and applications." (2007).‏

Schulman, Kevin A., K. Robin Yabroff, and Henry Glick. "A health services approach for the evaluation of innovative pharmaceutical and biotechnology products." Drug information journal 29.4 (1995): 1405-1414.‏

Kumara Behera, Basanta, et al. "Microbial Products Supply Chain." Microbial Biomass Process Technologies and Management (2017): 215-255.‏

Khan, Suliman, et al. "Role of recombinant DNA technology to improve life." International journal of genomics 2016 (2016).‏

Johnson, Irving S. "Human insulin from recombinant DNA technology." Science 219.4585 (1983): 632-637.‏

Salomon, Franco, et al. "The effects of treatment with recombinant human growth hormone on body composition and metabolism in adults with growth hormone deficiency." New England Journal of Medicine 321.26 (1989): 1797-1803.‏

Rowell, Frederick J., and JAMES R. FURR. "Recombinant DNA technology: monoclonal antibodies." Smith and Williams' Introduction to the Principles of Drug Design and Action. CRC Press, 2019. 491-508.‏

Hill, Daragh, et al. "Recent advances in microbial fermentation for dairy and health." F1000Research 6 (2017).‏

Hook, Derek J. "Production of antibiotics by fermentation." Basic Biotechnology (2006): 433.‏

Survase, Shrikant A., Ishwar B. Bajaj, and Rekha S. Singhal. "Biotechnological Production of Vitamins." Food Technology & Biotechnology 44.3 (2006).‏

Vittaladevaram, Viswanath. "Fermentative Production of Microbial Enzymes and their Applications: Present status and future prospects." Journal of Applied Biology and Biotechnology 5.4 (2017): 090-094.‏

D'Este, Martina, Merlin Alvarado-Morales, and Irini Angelidaki. "Amino acids production focusing on fermentation technologies–A review." Biotechnology advances 36.1 (2018): 14-25.‏

Ivanov, Kalin, et al. "Biotechnology in the production of pharmaceutical industry ingredients: amino acids." Biotechnology & Biotechnological Equipment 27.2 (2013): 3620-3626.‏

Bell, Elizabeth L., et al. "Biocatalysis." Nature Reviews Methods Primers 1.1 (2021): 46.‏

Hoyos, Pilar, Vittorio Pace, and Andrés R. Alcántara. "Biocatalyzed synthesis of statins: A sustainable strategy for the preparation of valuable drugs." Catalysts 9.3 (2019): 260.‏

Wegman, Margreth A., et al. "Towards biocatalytic synthesis of β‐lactam antibiotics." Advanced Synthesis & Catalysis 343.6‐7 (2001): 559-576.‏

Veronese, Francesco M., and Anna Mero. "The impact of PEGylation on biological therapies." BioDrugs 22 (2008): 315-329.‏

Ozturk, Sadettin, and Wei-Shou Hu, eds. Cell culture technology for pharmaceutical and cell-based therapies. CRC press, 2005.‏

Rappuoli, Rino. "Cell-culture-based vaccine production: technological options." BRIDGE-WASHINGTON-NATIONAL ACADEMY OF ENGINEERING- 36.3 (2006): 25.‏

Li, Feng, et al. "Cell culture processes for monoclonal antibody production." MAbs. Vol. 2. No. 5. Taylor & Francis, 2010.‏

Caplan, Arnold I. "Mesenchymal stem cells and gene therapy." Clinical Orthopaedics and Related Research (1976-2007) 379 (2000): S67-S70.‏

Soetaert, Wim, and Erick Vandamme. "The impact of industrial biotechnology." Biotechnology Journal: Healthcare Nutrition Technology 1.7‐8 (2006): 756-769.‏

Wohlgemuth, Roland. "The locks and keys to industrial biotechnology." New Biotechnology 25.4 (2009): 204-213.‏

Demling, Philipp, et al. "Quantitative measurements in single-cell analysis: towards scalability in microbial bioprocess development." Current opinion in biotechnology 54 (2018): 121-127.‏

Conner, John, et al. "The biomanufacturing of biotechnology products." Biotechnology entrepreneurship. Academic Press, 2014. 351-385.‏

Aggarwal, Saurabh. "Targeted cancer therapies." Nature reviews. Drug discovery 9.6 (2010): 427.‏

Tang, Lisa, et al. "Pharmacokinetic aspects of biotechnology products." Journal of pharmaceutical sciences 93.9 (2004): 2184-2204.‏

Neubauer, Peter, et al. "Consistent development of bioprocesses from microliter cultures to the industrial scale." Engineering in Life Sciences 13.3 (2013): 224-238.‏

Tibbetts, John H. "Synthetic Biology and Endangered Species: Should scientists genetically rewire nature to save species and habitats?." BioScience 72.7 (2022): 610-617.‏

Manole-Paunescu, Anca. "Biotechnology for endangered plant conservation." Biotechnology and Biodiversity (2014): 181-202.‏

Liu, Chunzhao, Yan Zhao, and Yuchun Wang. "Artemisinin: current state and perspectives for biotechnological production of an antimalarial drug." Applied microbiology and biotechnology 72 (2006): 11-20.‏

Vendrely, Charlotte, and Thomas Scheibel. "Biotechnological production of spider‐silk proteins enables new applications." Macromolecular bioscience 7.4 (2007): 401-409.‏

Duelen, Robin, et al. "Medicinal biotechnology for disease modeling, clinical therapy, and drug discovery and development." Introduction to Biotech Entrepreneurship: From Idea to Business: A European Perspective (2019): 89-128.‏

Salfeld, Jochen G. "Use of new biotechnology to design rational drugs against newly defined targets." Best Practice & Research Clinical Rheumatology 18.1 (2004): 81-95.‏

Zeng, Weizhu, et al. "High-throughput screening technology in industrial biotechnology." Trends in biotechnology 38.8 (2020): 888-906.‏

Ma, Cui-Cui, et al. "The approved gene therapy drugs worldwide: from 1998 to 2019." Biotechnology advances 40 (2020): 107502.‏

Riley, Rachel S., et al. "Delivery technologies for cancer immunotherapy." Nature reviews Drug discovery 18.3 (2019): 175-196.‏

Fasim, Aneesa, Veena S. More, and Sunil S. More. "Large-scale production of enzymes for biotechnology uses." Current opinion in biotechnology 69 (2021): 68-76.‏

Rathore, Anurag S., Deepak Kumar, and Nikhil Kateja. "Role of raw materials in biopharmaceutical manufacturing: risk analysis and fingerprinting." Current opinion in biotechnology 53 (2018): 99-105.‏

Broeze, Robert J. "Key challenges facing bio manufacturing." Bioprocessing and Biopartnering 2006 (2006): 14-16.‏

Kitney, Richard I. "Building the UK's industrial base in engineering biology." Engineering Biology 5.4 (2021): 98-106.‏

Gargalo, Carina L., et al. "Towards smart biomanufacturing: a perspective on recent developments in industrial measurement and monitoring technologies for bio-based production processes." Journal of Industrial Microbiology & Biotechnology: Official Journal of the Society for Industrial Microbiology and Biotechnology 47.11 (2020): 947-964.‏

Gargalo, Carina L., et al. "Towards the development of digital twins for the bio-manufacturing industry." Digital twins: Tools and concepts for smart biomanufacturing (2021): 1-34.‏

Miller, John. "Beyond biotechnology: FDA regulation of nanomedicine." Colum. Sci. & Tech. L. Rev. 4 (2002): 1.‏

Brennan, Frank R., et al. "Current strategies in the non-clinical safety assessment of biologics: New targets, new molecules, new challenges." Regulatory Toxicology and Pharmacology 98 (2018): 98-107.‏

Chen, Chao, and Genserik Reniers. "Risk assessment of processes and products in industrial biotechnology." Sustainability and Life Cycle Assessment in Industrial Biotechnology (2020): 255-279.‏

Pimenta, Cleila, et al. "Advanced therapies and regulatory framework in different areas of the globe: past, present, and future." Clinical Therapeutics 43.5 (2021): e103-e138.‏

Li, Jing, et al. "Advances in synthetic biology and biosafety governance." Frontiers in bioengineering and biotechnology 9 (2021): 598087.‏

Cardwell, Michael. "The Release of Genetically Modified Organisms into the Environment: Public Concerns and Regulatory Responses." Environmental Law Review 4.3 (2002): 156-170.‏

Murashov, Vladimir, John Howard, and Paul Schulte. "Synthetic Biology Industry: Biosafety Risks to Workers." Synthetic Biology 2020: Frontiers in Risk Analysis and Governance (2020): 165-182.‏

Udugama, Isuru A., et al. "Perspectives on resource recovery from bio-based production processes: from concept to implementation." Processes 5.3 (2017): 48.‏

Hashemi, Atieh. "CRISPR-Cas system as a genome engineering platform: applications in biomedicine and biotechnology." Current Gene Therapy 18.2 (2018): 115-124.‏

Hong, Andrew. "CRISPR in personalized medicine: Industry perspectives in gene editing." Seminars in perinatology. Vol. 42. No. 8. WB Saunders, 2018.‏

Germino-Watnick, Paula, et al. "Hematopoietic stem cell gene-addition/editing therapy in sickle cell disease." Cells 11.11 (2022): 1843.‏

Zarei, Ali, et al. "Creating cell and animal models of human disease by genome editing using CRISPR/Cas9." The journal of gene medicine 21.4 (2019): e3082.‏

Collins, Joseph H., and Eric M. Young. "Genetic engineering of host organisms for pharmaceutical synthesis." Current opinion in biotechnology 53 (2018): 191-200.‏

Andrianantoandro, Ernesto, et al. "Synthetic biology: new engineering rules for an emerging discipline." Molecular systems biology 2.1 (2006): 2006-0028.‏

David, Florian, et al. "A perspective on synthetic biology in drug discovery and development—current impact and future opportunities." SLAS DISCOVERY: Advancing the Science of Drug Discovery 26.5 (2021): 581-603.‏

Li, Yujie, et al. "Advances in synthetic biology-based drug delivery systems for disease treatment." Chinese Chemical Letters (2024): 109576.‏

Wang, Chi, et al. "Biosensor-based therapy powered by synthetic biology." Smart Materials in Medicine 4 (2023): 212-224.‏

Goetz, Laura H., and Nicholas J. Schork. "Personalized medicine: motivation, challenges, and progress." Fertility and sterility 109.6 (2018): 952-963.‏

Nair, Sunita R. "Personalized medicine: Striding from genes to medicines." Perspectives in clinical research 1.4 (2010): 146.‏

Ong, Frank S., et al. "Personalized medicine in ophthalmology: from pharmacogenetic biomarkers to therapeutic and dosage optimization." Journal of personalized medicine 3.1 (2013): 40-69.‏

Salari, Keyan, Hugh Watkins, and Euan A. Ashley. "Personalized medicine: hope or hype?." European heart journal 33.13 (2012): 1564-1570.‏

Published

2024-04-01

How to Cite

Shokoohi , M., & Attar , T. (2024). Biomanufacturing for a Sustainable Future: Unleashing the Potential of Biotechnology in Pharmaceutical Raw Material Production. International Journal of New Findings in Health and Educational Sciences (IJHES), 2(2), 142–153. https://doi.org/10.63053/ijhes.81

Issue

Section

Articles

Similar Articles

1 2 > >> 

You may also start an advanced similarity search for this article.