Future-Proof Your CDMO

Antibody Drug Conjugates (ADC) Process Development

Antibody-drug conjugates (ADCs) are a new class of biopharmaceutical drugs that use a chemical linker to bind monoclonal antibodies together with highly potent anti-cancer agents. For CDMOs, ADCs present a lucrative development opportunity, but success hinges on the ability to scale up processes effectively while maintaining Good Manufacturing Practice (GMP) and regulatory compliance. The data analytics process known as Design of Experiments (DOE) helps facilitate the development of  ADC processes. By enabling identification of important process parameters and a robust Design Space, DOE helps facilitate a faster and more reliable process for scale-up. 

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The webinar will cover the Piramal approach to the development of Antibody Drug Conjugates processes. Specifically, it will focus on the use of DOE to develop the key reactive stage of a standard ADC process. The impact of process parameters on product quality attributes, namely the Drug-to-Antibody ratio was assessed via full factorial design. The analysis of the design was assessed via Sartorius MODDE® 13 software. The software enabled to modelise the effects of parameters, allowing identification of setpoints for safe upscaling of the process.

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Here you can download the presentations from the webinar.

Download  Sartorius Presentation

Download Piramal Presentation