TITLE:
Antibody-Drug Conjugates (ADCs): Navigating Four Pillars of Safety, Development, Supply Chain and Manufacturing Excellence
AUTHORS:
Kishore Kumar Hotha
KEYWORDS:
Antibody Drug Conjugates, ADC’s, Payload, Linker, Antibody, HPAPI, Safety, Technology Transfer, CDMO, CMO
JOURNAL NAME:
Advances in Chemical Engineering and Science,
Vol.13 No.4,
October
19,
2023
ABSTRACT: 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.