During the 7th World ADC Summit in Berlin, Germany, held February 20 – 22, 2017, MilliporeSigma announced that the company will now offer complete and fully integrated services and products for the development and manufacturing of antibody-drug conjugates or ADCs.
While ADCs represent a relatively new class of promising anticancer drugs, the corresponding supply chain of monoclonal antibodies (mAbs), payloads and (chemical) linkers presents a significant challenge.
“…the unique and complex nature of an ADC requires expertise in small and large molecule development, manufacturing, formulation and testing…”
Antibody-drug conjugation technology includes monoclonal antibodies delivering potent, cytotoxic payloads (highly active pharmaceutical ingredients or HPAPIs) to specific targeted (cancer) cells. In conjugated form these payloads exhibit selective cytotoxicity which help spare non-target cells from toxic effects, thereby improving the overall safety profile of the therapy for the patient.
The unique and complex nature of an ADC requires expertise in small and large molecule development, manufacturing, formulation and testing. In addition, the manufacturing of ADCs requires advanced manufacturing suites and dedicated equipment to characterize the molecule and demonstrate its purity, homogeneity and stability.
Purification and Containment
Optimized and robust purification, using chromatography (hydrophobic interaction or ion exchange) or tangential fow filtration (TFF) are essential to remove process related contamination as well as residuals of linkers and cytotoxic agent, and to concentrate the active pharmaceutical ingredient or API and stabilize the final product. And, to protect operators and the environment from any contamination, these manufacturing facilities require an extended containment strategy.
With more than 30 years of experience in development and manufacturing of biologics, conjugation processes and small molecules, MilliporeSigma’s combined offering provides state-of-the-art technologies for manufacturing and conjugation including process development and manufacturing of monoclonal antibodies, linker and payload supply and conjugation expertise. A seamless process from gene sequencing to stability testing of drug products enables customers to reduce development and manufacturing complexity. This process is based on a streamlined supply chain for raw materials, industry-leading global logistics expertise. A single point of contact for each project, mitigates risks, reduces complexity and accelerates time to market.