Single-Use ADC Equipment: From Lab Scale-Up To GMP Production

By Gang Yao, Ph.D., Principal Scientist, Process and Analytical Development; Mary Robinette, Principal Project Engineer, API Global Engineering; Gary Conway, Principal Production Scientist, cGMP Manufacturing; MilliporeSigma Kevin Reyer, Project Engineer, Engineering

The ADC Market is Fast Growing
According to the research report “Global Antibody Drug Conjugates (ADC) Market – Analysis By Drugs (Adcetris, Kadcyla), Pipeline Drugs, Regulations: Opportunities and Forecasts (2017-2022),” the global ADC market is projected to display robust growth, represented by a compound annual growth rate (CAGR) of 21.82% during 2017-2022. This growth is chiefly driven by the large number of ADC drugs in the pipeline, the rising number of cancer patients, and the wider therapeutic window offered by antibody-drug conjugates (www.researchandmarkets.com/research/q6jlz9/global_antibody).

Customer A commissioned MilliporeSigma to perform the technology transfer and optimization of bioprocess chemistry and associated analytical methods to enable the production of antibody-drug conjugate bulk drug substance ADC-X with 1000 gram antibody under cGMP. This material will be used as an active pharmaceutical ingredient for human phase 1 clinical trials. The ADC-X construct features a novel IgG1 isotype antibody conjugated to a new drug-linker.

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