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The development of biologics-based therapies is part of the ongoing quest to improve human health. Since their introduction in 1982, biologics have been blazing new trails for the treatment of a broad spectrum of diseases. New therapies driven by technological advances in bioproduction have led to exciting opportunities to improve human health while addressing new patient populations and unmet medical needs.
Biologics are complex, large-molecule therapeutics manufactured in living systems such as microorganisms, insect cells, or animal cells; human cells that have been genetically reprogrammed to attack specific disease targets are also considered biologics. Biologics may include a wide range of products, such as proteins, antibodies, messenger RNA (mRNA), and advanced therapy medicinal products (ATMPs).
Recombinant DNA technology led to the development of recombinant insulin, first produced in 1978 and made commercially available in 1982.1 Recombinant human insulin continues to be a mainstay of treatment for type 1 and advanced type 2 diabetes mellitus.1
The first monoclonal antibody was fully licensed in 1986 for the prevention of kidney transplant rejection.2 Today, monoclonal antibodies are indicated for the treatment of a variety of conditions including cancer and cardiovascular, infectious, and autoimmune/inflammatory diseases.
For decades, scientists pondered the seemingly endless therapeutic potential of mRNA in the field of cancer.3 But the urgency of the coronavirus disease 2019 (COVID-19) pandemic spurred the rapid development and commercialization of the first mRNA vaccines approved by the U.S. Food and Drug Administration (FDA).4 Researchers are now exploring applications of the technology as a tool against emerging coronavirus variants and other infectious diseases, such as human immunodeficiency virus (HIV), Epstein-Barr virus, and cytomegalovirus (CMV).5-9
Scientific research continues to drive therapeutic discovery with ATMPs, a fast-growing field of innovation.10 These groundbreaking products are expected to address challenging therapeutic targets that have evaded conventional therapies, slowing disease progression, and perhaps even offering the promise of a cure for diseases that were once considered incurable. In the United States, these technologies, which include cell and gene therapies such as chimeric antigen receptor (CAR) T-cell therapies, are expected to revolutionize the treatment paradigms for many complex conditions.11
Seven of the top 10 best-selling medicines globally are biologics.12 Of the 209 drugs approved by the FDA from 2000 to 2008, 7.17% were biologics.13 This number has increased exponentially in recent years: 15.56% of the 302 drugs approved by the FDA from 2009–2017 were biologics.13 In 2021 alone, 28% of the 50 drugs approved by the FDA were biologics,14 including an mRNA COVID-19 vaccine and CAR-T therapies.15,16
Because biologics are manufactured in living organisms such as animal and microbial cells, as the field of biotherapeutics continues to grow, so will the demand for bioprocessing and related services. Yield and quality of product is heavily dependent on the cell culture process, a crucial component of which is cell culture media optimization. As new large-molecule therapies hit the drug development pipeline, relying on the expertise and capabilities of companies like FUJIFILM Irvine Scientific’s Media Development and Optimization (MDO) program to co-create custom formulations helps address product-specific bioprocessing challenges in real time.17
One of the biggest challenges in the development, manufacture and commercialization of any advanced therapy comes early on, when cell culture media and workflow decisions are made. When first choosing cell culture media, focus is typically placed on its functionality— how it will affect cell expansion and viability, whereas considerations as to its scale-up potential and regulatory compliance might be overlooked.
For instance, media that work at a small scale may rely on complex or undefined components, such as human serum, which can introduce the possibility of manufacturing errors later in the scale-up process. Appropriate packaging must also be considered when scaling-up cell culture, as it requires that media bottles typically used in small-scale studies be replaced by bag or powder formats in automated, large-scale processes. In addition, it’s important to ascertain whether the media is available in all regions where the therapy will be manufactured, and assess the stability of the supply chain for all ingredients in the formulation, particularly for advanced therapies such as CAR T-cell therapy that require a constant supply of media for cell expansion.
Understanding and accounting for regulatory requirements in media formulation and process development is yet another important consideration in the early stages of protocol design and media optimization. Early development is often achieved using commercially-available media with poorly defined or undefined components, while media used in the clinical development and commercial manufacturing stages must meet international regulatory guidelines and local requirements.18 Achieving these considerations early in the development process can ensure high-quality production and save valuable time and money.
FUJIFILM Irvine Scientific’s deep expertise in cell biology and cell culture optimization makes them a leading cell culture media supplier. Through the supply of quality media, they help customers navigate the journey from early-stage development to clinical applications and commercial manufacturing.
Optimization of cell culture media is a key component in the design and implementation of consistent and reproducible biomanufacturing operations, facilitating rapid delivery of biologics to patients in need. By helping to accelerate therapeutic innovation, Fujifilm is looking forward to a more promising future for all.
1. Landgraf W, Sandow J. Recombinant human insulins – clinical efficacy and safety in diabetes therapy. Eur Endocrinol. 2016;12(1):12–17.
2. Liu JKH. The history of monoclonal antibody development – progress, remaining challenges and future innovations. Ann Med Surg (Lond). 2014;3(4):113–116.
3. Dolgin E. The tangled history of mRNA vaccines. Nature. 2021;597(7876):318–324.
4. U.S. Food and Drug Administration. FDA approves first COVID-19 vaccine. Press release. Published August 23, 2021. Accessed January 31, 2022. https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine
5. Moderna. IAVI and Moderna launch trial of HIV vaccine antigens delivered through mRNA technology. News release. Published January 27, 2022. Accessed January 31, 2022. https://investors.modernatx.com/news/news-details/2022/IAVI-and-Moderna-Launch-Trial-of-HIV-Vaccine-Antigens-Delivered-Through-mRNA-Technology/default.aspx
6. Moderna. Moderna announces first participant dosed in phase 1 study of its mRNA Epstein-Barr virus (EBV) vaccine. News release. Published January 5, 2022. Accessed January 31, 2022. https://investors.modernatx.com/news/news-details/2022/Moderna-Announces-First-Participant-Dosed-in-Phase-1-Study-of-its-mRNA-Epstein-Barr-Virus-EBV-Vaccine/default.aspx
7. Moderna. Moderna announces first participant dosed in phase 3 pivotal registration study of its mRNA cytomegalovirus (CMV) vaccine. News release. Published October 26, 2022. Accessed January 31, 2022. https://investors.modernatx.com/news/news-details/2021/Moderna-Announces-First-Participant-Dosed-in-Phase-3-Pivotal-Registration-Study-of-Its-mRNA-Cytomegalovirus-CMV-Vaccine-10-26-2021/default.aspx
8. Garde D. The story of mRNA: How a once-dismissed idea became a leading technology in the Covid vaccine race. Stat News. Published November 10, 2020. Accessed January 31, 2022. https://www.statnews.com/2020/11/10/the-story-of-mrna-how-a-once-dismissed-idea-became-a-leading-technology-in-the-covid-vaccine-race/
9. Eisenstein M. For mRNA vaccines, COVID-19 is just the beginning. Johns Hopkins Bloomberg School of Public Health. Published January 29, 2021. Accessed January 31, 2022. https://publichealth.jhu.edu/2021/for-mrna-vaccines-covid-19-is-just-the-beginning
10. Iglesias-Lopez C, Agustí A, Mercè O and Vallano A. Regulatory framework for advanced therapy medicinal products in Europe and United States. Front Pharmacol. 2019;10:921.
11. Hanna E, Rémuzat C, Auquier P, Toumi M. Advanced therapy medicinal products: current and future perspectives. J Mark Access Health Policy. 2016;4.
12. Jallal B. Realizing the promise of biologics. Harvard Health Policy Review. Published April 9, 2017. Accessed January 31, 2022. http://www.hhpronline.org/articles/2017/4/9/realizing-the-promise-of-biologics
13. Batta A, Kalra BS, Khirasaria R. Trends in FDA drug approvals over last 2 decades: an observational study. J Family Med Prim Care. 2020;9(1):105–114.
14. U.S. Food and Drug Administration. Novel drug approvals for 2021. Published January 6, 2022. Accessed January 31, 2022. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2021#:~:text=Novel%20Drug%20Approvals%20for%202021%20%20%20,cardiovascular%20d%20…%20%2019%20more%20rows%20
15. U.S. Food and Drug Administration. 2021 Biological License Application approvals. Published December 20, 2021, Accessed January 28, 2022. https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/2021-biological-license-application-approvals
16. Mullard, A. 2021 FDA approvals. Nat Rev Drug Discov. Published online ahead of print on January 4, 2021. doi:10.1038/d41573-022-00001-9
17. FUJIFILM Irvine Scientific, Inc. Providing a good foundation. In: ILLUMINATE – booklet introducing Fujifilm’s cutting-edge technologies. Brochure published by Nature Research Custom Media, part of Springer Nature; March 2020. Accessed January 28, 2022.
18. U.S. Food and Drug Administration. Guidance for Industry. Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products, June 2021. Updated August 27, 2021. Accessed January 28, 2022. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/chemistry-manufacturing-and-controls-changes-approved-application-certain-biological-products
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For more information on Fujifilm’s initiatives in cell culture media solutions, click here. [https://lifesciences.fujifilm.com/cell-culture-media]
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