%0 Journal Article
%T Antibody-Drug Conjugates (ADCs): Navigating Four Pillars of Safety, Development, Supply Chain and Manufacturing Excellence
%A Kishore Kumar Hotha
%J Advances in Chemical Engineering and Science
%P 351-362
%@ 2160-0406
%D 2023
%I Scientific Research Publishing
%R 10.4236/aces.2023.134024
%X 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.
%K Antibody Drug Conjugates
%K ADC¡¯s
%K Payload
%K Linker
%K Antibody
%K HPAPI
%K Safety
%K Technology Transfer
%K CDMO
%K CMO
%U http://www.scirp.org/journal/PaperInformation.aspx?PaperID=128381