Accelerating the development of antibody-drug conjugates (ADCs) is critical to addressing unmet medical needs. The modality is transforming the lives of cancer patients by providing powerful anti-tumor effects without intolerable side effects. Many in the pharmaceutical industry believe that ADCs are positioned to become the first choice oncology treatments in the coming years. However, the complex supply chain poses challenges that can delay the filing of investigational new drug (IND) applications and ultimately the approval of life-changing drugs.
To meet the chemistry, manufacturing and control requirements (CMC), drug developers must show they have: full chain of custody of all the raw materials; a repeatable, reproducible manufacturing process that works at clinical scale and is backed by the required process controls; and analytical methods and tests that show the process is repeatable and provides control over the purity and identity of the drug. Read the whitepaper to learn in detail about our Integrated ADC program.
