Antibody-drug conjugates (ADCs) are pioneering biologics that merge antib odies’ specificity with small molecules’ potency. With a handful of FD A- 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 s tages underscores the urgency for quick and efficient commercial lau nch 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.
KeywordsAntibody Drug ConjugatesADC’sPayloadLinkerAntibodyHPAPISafetyTechnology TransferCDMOCMO
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