Cancer treatment is the primary application, so far, of antibody–drug conjugate product development. Lessons learned here will help companies expand this product modality into other areas. Authors in this featured report seek to characterize the current state of the ADC industry, science, and technology with an eye toward the future. They focus on process/manufacturing and product development issues, highlighting successes so far and potential for the future.
Building Toward Antibody–Drug Conjugate Success
To succeed clinically, antibody–drug conjugates for cancer treatment need to target the right antigen using the right antibody with the most powerful cytotoxin attached by best linker option. These features combine to endow the resulting conjugated product with therapeutic safety and efficacy. Here, BPI’s senior technical editor examines the current state of ADC development and technology, with product approvals beginning to fulfill their potential, developers identifying and addressing manufacturing issues, and researchers and regulators doing their best to pave the way forward.
Antibody–Drug Conjugate News: From BioProcess Insider
Dan Stanton and Gareth Macdonald
A curated collection of business news items from a year of BioProcess Insider throw light on the direction in which the ADC sector is moving: Seattle Genetics aspires to “big pharma” status, NIIMBL and BPOG publish roadmaps, Ajinomoto Bio-Pharma Services enters the ADC contract development and manufacturing arena, and development collaborations feature AstraZeneca with Daiichi Sankyo and Celltrion with iProgen Biotech, and Synthon Biopharmaceuticals chooses to keep all ADC work in house.
Analytical Tools to Improve Decision-Making During Product Development
As manufacturing bottlenecks shift from process development groups to analytical testing laboratories, biopharmaceutical companies often face an in-house/outsource dilemma over analysis of early stage experiments. The author provides an ADC example of how cost-effective analytical tools can enable rapid decision making during product and process development.