Antibody-drug conjugates (ADCs) are among the most promising modalities in oncology – but bringing them into the clinic isn’t straightforward. One of the most underestimated challenges? Formulation development.
ADCs combine three fragile components – an antibody, a linker, and a highly potent payload. Each can degrade in different ways, and if the formulation doesn’t control those risks, the entire program is at stake. What many don’t realize is that ADC CMC work is extremely expensive. Because of that, early-stage companies often aim to manufacture one GMP batch that can last through Phase I and even Phase II clinical trials. That strategy only works if the formulation is rock-solid.
A strong formulation must:
- Maintain stability over multiple years
- Prevent aggregation and linker/payload degradation
- Protect DAR integrity
- Enable consistent, safe handling at clinical sites
If the batch doesn’t hold up, teams face high costs, delays, comparability challenges – and sometimes program-ending setbacks. ADC formulation isn’t a “nice to have.” It’s one of the most critical investments you can make to protect your clinical timeline and budget.
At ProJect Pharmaceutics we are well aware of those challenges and develop ADC formulations tailored to each individual ADC molecule taking into account its intrinsic physicochemical properties in solution. One fits all and any platform formulation concepts disregard the “sweet spot” that each particular molecule intrinsically features when it comes to stability. However, formulating around the “sweet spot” by scientific understanding of the molecule’s physicochemical properties paves the way towards a strong ADC formulation and clinical success. ProJect Pharmaceutics has been developing ADC formulations since >15 years – 9% thereof are in phase III now, 18% in phase II, 14% in phase I/II, and 14% have completed phase I.
De-risk your ADC program with a best-in-class drug product formulation. Partner with us and let our experienced team safeguard your molecule’s clinical future.
