Single-use technologies in bio manufacturing: benefits and implementation challenges
-
Sanket J Soni
Associate Director, Department of Project and Portfolio Management, Amneal Pharmaceuticals, New Jersey, USA.
sanket45.com@gmail.com
- Ankitkumar N Patel Director of Formulation, Department of Formulation R&D, Amneal Pharmaceuticals, New Jersey, USA.
Abstract
Single-use technologies (SUT) have revolutionized the bio manufacturing industry by offering flexibility, cost efficiency, and improved contamination control. Initially adopted for simpler processes, SUT has expanded to complex bioprocessing operations, driven by the growing demand for biologics, vaccines, and personalized medicines. This review explores the benefits of SUT, including reduced capital and operational expenditures, faster setup and turnaround times, and enhanced product safety. The scalability of SUT allows for rapid adaptation to market demands, significantly accelerating the time-to-market for critical therapies. However, the implementation of SUT is not without challenges. Material compatibility, leachables, waste management, and supply chain reliability pose significant hurdles. Moreover, regulatory and validation challenges complicate the adoption of these technologies in large-scale production. Case studies, including the rapid deployment of COVID-19 vaccines and the production of monoclonal antibodies, illustrate SUT's practical applications and benefits. The review also examines future trends, highlighting advances in materials, automation, and digital integration, as well as the expanding applications of SUT in cell and gene therapy manufacturing. As the bio manufacturing landscape continues to evolve, SUT will play a crucial role in meeting the industry's growing needs, provided the challenges associated with its implementation are effectively managed.
Keywords:
thyroid gland, Single-use technologies, bio manufacturing, contamination control, regulatory challenges, waste management, automation, digital integration
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References
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2. Liu HF, Ma J, Winter C, Bayer R. Current practices and challenges in using single-use technologies for viral vector manufacturing. BioProcess Int. 2020;18(3):18-27.
3. Cacciuttolo MA. Advances in single-use technology in the manufacture of biologics. Biotechnol J. 2018;13(7)
4. Shukla AA, Gottschalk U. Single-use disposable technologies for biopharmaceutical manufacturing. Trends Biotechnol. 2013;31(3):147-54.
5. Eibl R, Kaiser S, Löffelholz C, Eibl D. Disposable bioreactors: the current state-of-the-art and recommended applications in biotechnology. Appl MicrobiolBiotechnol. 2010;86(1):41-9.
6. Subramanian G. Single-use technology in biopharmaceutical manufacturing: a review of the current state of the industry. BioPharm Int. 2017;30(10):34-8.
7. Bisschops MM, Spierings LH. Single-use technologies in the upstream and downstream process of biopharmaceutical production. BioProcess Int. 2014;12(11):20-30.
8. Farid SS. Process economics of industrial monoclonal antibody manufacture. J Chromatogr B Analyt Technol Biomed Life Sci. 2007;848(1):8-18.
9. Birch JR, Racher AJ. Antibody production. Adv Drug Deliv Rev. 2006;58(5-6):671-85.
10. Montaño LA, Middelberg APJ. Single-use bioreactors for microbial fermentation. Curr OpinChem Eng. 2018;22:7-13.
11. Sinclair A, Monge M, Xu P. The impact of single-use technologies on the economics of biopharmaceutical manufacturing. Bioprocess Int. 2010;8(6):26-31.
12. Klein D, Malmqvist E, Eriksson R, Lütkemeyer D. Implementation of single-use bioreactors for large-scale manufacture of therapeutic proteins. Pharm Bioprocess. 2016;4(1):25-34.
13. Phillips M, Katzer A. Regulatory challenges in the implementation of single-use technologies in biopharmaceutical manufacturing. Pharm Eng. 2015;35(6):1-5.
14. Eibl R, Eibl D. Application of single-use bioreactors in tissue engineering and cell-based therapies. Adv BiochemEngBiotechnol. 2011;123:139-57.
15. Eibl R, Eibl D. Design and use of the wave bioreactor for plant cell culture. In: Doran PM, editor. Plant Cell Culture Technology. Heidelberg: Springer-Verlag; 2013. p. 55-82.
16. Lim A, Kim JH, Kim S. Economic benefits of implementing single-use technologies in manufacturing processes for biologics. J MicrobiolBiotechnol. 2017;27(7):1229-34.
17. Chon JH, Zarbis-Papastoitsis G. Advances in the production and downstream processing of antibodies. In: Jungbauer A, editor. Biotechnology of Plasma Proteins. Hoboken: John Wiley & Sons; 2012. p. 165-89.
18. Werth KD, Mun M, Yoon SH, Gerngross TU. Optimization and scale-up of a disposable bioreactor for microbial fermentation. BiotechnolBioeng. 2006;93(6):1210-21.
19. Zhang X, Ding W, Sun W. Development of a robust single-use bioreactor system for mammalian cell culture. Biotechnol Lett. 2014;36(9):1913-8.
20. Saracco L, Medolla F, Charrier A. Leveraging single-use systems for flexibility in multi-product facilities. BioPharm Int. 2019;32(6):18-23.
21. Zhang J, Zhou D, Lin Y. Recent advancements in single-use bioreactors: a comprehensive review. Biotechnol Adv. 2021;47:107697.
22. Mukhopadhyay T, Woodle M. Implementation of single-use technologies in the production of gene therapy vectors. Mol Ther Methods Clin Dev. 2019;13:135-44.
23. Ravella S, Angel M, Subramanian H, Thangavel N, Namballa M, Lokesh D, Mishra AK, Nagaraju GV. Navigating the Future of Cancer Diagnosis: A Comprehensive Review of Novel Approaches for Community-Based Treatment. future.;1:6.
24. Manda, P., Popescu, C., Juluri, A. et al. Micronized Zaleplon Delivery via Orodispersible Film and Orodispersible Tablets. AAPS PharmSciTech 19, 1358–1366 (2018).
25. Lakshmi Narasimha Rao, K., Praneeth Rao, K. Development and Validation of a Stability-Indicating LC Method for Determination of Bexarotene in Softgel Dosage Formulation. Chromatographia 80, 1211–1224 (2017).
26. Kakulamarri PR, Alikatte KL, Mateti UV (2016) Transdermal Iontophoresis of Non-Polar Drugs: A Mini Review. J Pharm Drug Deliv Res 5:3
27. Kakullamarri PR, Rao KLN (2017) Enhanced Bioavailability and Anticancer Activity of Vitamin Analogs. J BioequivAvailab 9: 439-441.
28. Rader RA. Single-use technology: advancements and adoption in bioprocessing. BioPharm Int. 2011;24(10):54-8.
29. Marichal-Gallardo P, Álvarez MM. State-of-the-art in downstream processing of monoclonal antibodies: process trends in design and validation. BiotechnolProg. 2020;36(2)
30. Cruz HJ, Freitas CM, Alves PM, Mota M. Bioprocess integration using single-use technologies: opportunities and challenges. BiotechnolProg. 2020;36(1)
31. Joseph B, Hussain A, Ahuja A. Digital transformation in biomanufacturing: leveraging automation and single-use technologies for flexible production. Pharm Eng. 2021;41(2):76-84.
32. Pollock J, Ho SV, Farid SS. Fed-batch and perfusion culture processes: economic, environmental, and operational feasibility under uncertainty. BiotechnolBioeng. 2013;110(8):2064-76.
33. Kumar KR, Nagaraju GV, Subrahmanyam SN, Nagarani K, Shareef S, Tennygilphin M, Namballa M. Assessment on Elements Involving the Academic Performance among Pharmacy Students: A Cross-Sectional Observational Study. Int J Cur Res Rev| Vol. 2021 Dec;13(23):141.
34. Küpper S, Reif O, Zimmermann A. Industrial production of therapeutic proteins: challenges in downstream processing. In: Horvath C, editor. Preparative Chromatography of Fine Chemicals and Pharmaceutical Agents. Amsterdam: Elsevier; 2019. p. 303-25.
35. Doran PM. Design of bioprocessing systems: considerations for single-use technology implementation. J Biotechnol. 2013;167(3):305-12.
36. Rathore AS, Agarwal H. Challenges and solutions in the development of single-use technologies for biomanufacturing. BioProcess Int. 2018;16(2):22-30.
37. Dherin C, Sommerfeld S, Lee J. Application of single-use technologies in the commercial manufacturing of therapeutic proteins. Pharm Bioprocess. 2017;5(3):131-8.
38. Forcina V, Mastroberardino L, Mori M. Integrating single-use technologies and continuous processing for the production of therapeutic proteins. Bioprocess Int. 2020;18(7):40-7.
39. Korhonen J, Rajamäki K. Cost-benefit analysis of single-use versus stainless-steel bioreactors: economic implications for commercial manufacturing. BioProcess Int. 2014;12(8):40-7.
40. McKnight TE, Zeng X, Bernasconi C. Single-use bioreactor applications in perfusion culture. BioProcess Int. 2017;15(10):58-64.
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Soni, S. J., & Patel, A. N. (2024). Single-use technologies in bio manufacturing: benefits and implementation challenges. Asian Journal of Hospital Pharmacy, 4(4), 1-7. https://doi.org/10.38022/ajhp.v4i4.92
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