Antibody Drug Conjugates (ADCs) are a class of biomolecules that has seen rapid growth as an oncology therapeutic. While templated manufacturing processes for the monoclonal antibody (mAb) backbone are widely established, optimized and scalable strategies for linker/payload addition to the mAb and subsequent downstream purification/formulation of the ADC are still being developed. Special consideration for safe handling and containment of these operations are necessary due to the organic solvents required for the conjugation reaction and the highly potent, toxic nature of the small molecule payload.

Single-use technology offers much promise to successfully address these concerns. This webinar will illustrate how the single-use technology vendor and the ADC manufacturer play a role in designing, qualifying, and implementing fit-to-purpose single-use equipment, flowpaths, and processes to deliver consistent and scalable ADC chemistry and functionality with desired final product specifications and high yield.  In addition, lessons learned during cGMP production startup will be discussed.

In this webinar, you will learn: