Tag: maytansinoids

The Evolution of HPAPI Manufacturing for CDMOs

HPAPIs are the new center of gravity.Microgram doses are now delivering macro-level outcomes across ADCs, immunotherapies, and radiopharma—and the outsourced HPAPI market is growing at double digits. The winners? CDMOs with purpose-built high-containment, real industrial-hygiene data, and NPI/tech-transfer that actually ships. This isn’t “more GMP”—it’s QbD fused to exposure control, picogram-level cleaning limits, and multilayer […]