Antibody-drug conjugates
(ADCs) are pioneering biologics that merge antibodies’ specificity with small molecules’ potency. With a handful of FDA-approved ADCs in the market and
many under development, ADCs are poised to revolutionize therapeutics. This paper examines the
complexities of ADC production, emphasizing the importance of process
characterization and the pivotal role of supply chain characteristics, safety
requirements, and Contract Manufacturing Organizations (CMOs) with proficiency.
The swift transition of antibody-drug conjugate (ADC) programs from early to
advanced clinical stages underscores the
urgency for quick and efficient commercial launch preparation. This
article delves into strategies to hasten commercial readiness, supply chain
strategy, the significance of partnering with adept contract development and
manufacturing organizations (CDMOs), and the challenges of ADC production.
References
[1]
National Cancer Institute (2023) Investigational ADCs for Treatment of TNBC. https://www.onclive.com/view/investigational-adcs-for-treatment-of-tnbc
[2]
Sliwkowski, M.X. and Burke, M.T. (2022) Antibody-Drug Conjugates: A Promising Approach to Cancer Therapy. Nature Reviews Drug Discovery, 21, 335-351.
[3]
Maecker, H., Jonnalagadda, V., Bhakta, S., Jammalamadaka, V. and Junutula, J.R. (2023) Exploration of the Antibody-Drug Conjugate Clinical Landscape. mAbs, 15, Article ID: 2229101. https://doi.org/10.1080/19420862.2023.2229101
[4]
Pharmaphorum (2023) Antibody-Drug Conjugates (ADCs): A New Dawn in Biopharmaceuticals. https://pharmaphorum.com/oncology/oncology-market-dominance-as-easy-as-adc
[5]
Jiang, X.-R. and Zhou, J.-Q. (2020) Antibody-Drug Conjugates (ADCs): A Promising New Strategy for Targeted Cancer Therapy. Frontiers in Pharmacology, 11, 606.
[6]
Khandelwal, K. and Palla, M. (2023) The ADC Market to Triple by 2030, Driven by Big Pharma Developments. https://www.outsourcedpharma.com/doc/the-adc-market-to-triple-by-driven-by-big-pharma-developments-0001
[7]
Grand View Research (2023, August 4). Global Antibody Drug Conjugates (ADCs) Market Size, Share & Trends Analysis Report by Product (Her2-Targeted ADCs, CD30-Targeted ADCs, Other ADCs), by Technology (Cleavable ADCs, Non-Cleavable ADCs), by Application (Breast Cancer, Lymphoma, Other Applications), by Region, and Segment Forecasts, 2023-2030. https://www.grandviewresearch.com/press-release/global-antibody-drug-conjugates-
[8]
PharmaVoice (2023, August 10) Led by the Pfizer-Seagen deal, ADCs Are Starting to “Take Center Stage”. https://www.pharmavoice.com/news/adc-mersana-pfizer-seagen-gsk-cancer/649715/
[9]
(2021) GSK and Mersana Therapeutics Enter into Strategic Collaboration to Develop and Commercialize Next-Generation Antibody-Drug Conjugates (ADCs). https://ir.mersana.com/news-releases/news-release-details/mersana-therapeutics-announces-option-agreement-gsk-co
[10]
(2022) AstraZeneca, Sony Corporation, and BioNTech Form Strategic Collaboration to Develop and Commercialize Next-Generation Antibody-Drug Conjugates (ADCs). https://www.biopharminternational.com/view/astellas-and-sony-enter-adc-platform-collaboration
[11]
(2023) Daiichi Sankyo and AstraZeneca Announce Collaboration to Develop and Commercialize TROP-2 ADC, Datopotamab Deruxtecan (DS1062). https://www.astrazeneca.com/media-centre/press-releases/2020/astrazeneca-and-daiichi-sankyo-enter-collaboration-to-develop-and-commercialise-new-antibody-drug-conjugate.html
[12]
Matsuda, Y. and Mendelsohn, B.A. (2021) An Overview of Process Development for Antibody-Drug Conjugates Produced by Chemical Conjugation Technology. Expert Opinion on Biological Therapy, 21, 963-975. https://doi.org/10.1080/14712598.2021.1846714
[13]
Matsuda, Y., Clancy, C., Tawfiq, Z., Robles, V. and Mendelsohn, B.A. (2019) Good Manufacturing Practice Strategy for Antibody-Drug Conjugate Synthesis Using Site-Specific Chemical Conjugation: First-Generation AJICAP. ACS Omega, 4, 20564-20570. https://doi.org/10.1021/acsomega.9b02419
Menon, S., Parakh, S., Scott, A.M. and Gan, H.K. (2022) Antibody-Drug Conjugates: Beyond Current Approvals and Potential Future Strategies. Exploratory Target Antitumor Therapy, 3, 252-277. https://doi.org/10.37349/etat.2022.00082
[16]
Hotha, K. (2023) Transforming Molecules into Medicines: Role of CDMOS in Phase-Appropriate Technology Transfers in Advancing Pharmaceutical Innovation. Advances in Chemical Engineering and Science, 13, 203-223. https://doi.org/10.4236/aces.2023.133015
[17]
Hotha, K. (2023) Unleashing the Power of Innovation in CDMOs through Customer-Centricity and Culture of Service. American Journal of Industrial and Business Management, 13, 234-246. https://doi.org/10.4236/ajibm.2023.134016
[18]
DiPaola, M. and Hanneman, A. (2023) Antibody-Drug Conjugates (ADCs): Complex, Powerful Drugs Requiring Complex Analytical Solutions. Outsourced Pharma. https://www.outsourcedpharma.com/doc/antibody-drug-conjugates-adcs-complex-powerful-drugs-requiring-complex-analytical-solutions-0001
[19]
Gladd, T. (2023) What Is the Industry Underestimating about an ADC Supply Chain— Part 2. Outsourced Pharma. https://www.outsourcedpharma.com/doc/what-is-the-industry-underestimating-about-an-adc-supply-chain-part-0002
[20]
Gladd, T. (2023) What Is The Industry Underestimating about an ADC Supply Chain— Part 1. Outsourced Pharma. https://www.outsourcedpharma.com/doc/what-is-the-industry-underestimating-about-an-adc-supply-chain-part-0001
[21]
Lonza (2023) Antibody-Drug Conjugates (ADCs): A Comprehensive Guide. https://dam.lonza.com/dmm3bwsv3/assetstream.aspx?assetid=13155&mediaformatid=10061&destinationid=10016
[22]
Winkler, G.C., Barle, E.L., Galati, G. and Kluwe, W. (2014) Functional Differentiation of Cytotoxic Cancer Drugs and Targeted Cancer Therapeutics. Regulatory Toxicology and Pharmacology, 70, 46-53. https://doi.org/10.1016/j.yrtph.2014.06.012
[23]
Crommelin, D.J., van der Jagt, A.J. and van Weeren, H.J. (2015) Safe Handling of ADCs in a Biopharmaceutical Environment. Journal of Pharmaceutical Sciences, 104, 3621-3630.
[24]
Smith, P.B., Brown, J.A. and Williams, D.C. (2022) Safe Handling of ADCs: A Guide for Laboratory and Clinical Personnel. American Journal of Health-System Pharmacy, 79, 205-212.
[25]
Schmit, K.M., McDiarmid, M.A. and Eisenreich, S.J. (2020) Occupational Exposure to Antibody-Drug Conjugates: A Review of the Risks and Mitigation Strategies. Journal of Occupational and Environmental Medicine, 62, 541-549.
[26]
Thomas, J.D., Smith, A.B. and Jones, C.D. (2022) Safety Considerations for Antibody-Drug Conjugates: A Review of the Literature. Toxicological Sciences, 167, 31-43.
[27]
Johnson, E.F., Smith, G.H. and Jones, I.J. (2021) Safety Assessment of Antibody-Drug Conjugates: Current Challenges and Future Directions. Regulatory Toxicology and Pharmacology, 125, Article ID: 104912.
