SAFC® Commercial, the custom manufacturing services business unit of Sigma-Aldrich® Corporation (Saint Louis, MO), has introduced ADC Express℠ within its Contract Manufacturing Services portfolio.
The new antibody drug conjugate (ADC) offering includes rapid preparation of development grade conjugate constructs for clients to use in their target molecule identification.
Antibody-drug conjugates are designed to overcome the limitations of both nonspecific cytotoxic drugs and specific but ineffective monoclonal antibody therapy by combining the cytotoxic potential of a chemotherapeutic anticancer drug with the specificity of the monoclonal antibody. One critical parameter that affects the efficacy, therapeutic window, and toxicity profile of ADCs involved the selection of the appropriate target for the ADC during the discovery phase.
Commenting on the new product offering, Cynthia Wooge, Ph.D, Global Strategic Marketing Manager for SAFC, explained: “ADC Express reflects our drive to offer our customers a full service solution to the development of their ADCs. SAFC is the reliable, experienced partner that customers can depend on as they navigate the complex and challenging discovery phase of ADCs.”
“ADC Express allows our customers to leverage our platform expertise when they need it most, providing development grade constructs to fit timeline and budget obligations,” Wooge continued.
Speeding up development
By using the company’s bioconjugation expertise clients can reduce the time needed to produce development grade constructs for target molecule identification. Leveraging SAFC’s platform technology helps them to efficiently turn their antibody, linker and payload into an ADC.
The new ADC Express service provides efficient rapid production and delivery of development grade ADC constructs at scales of 10–200 mg (+/- column purification), certificate of testing with key quality attributes, ADC concentration, payload density DAR (drug antibody ratio) and monomer/aggregate content.
Collaboration with Baxter
In September 2014 SAFC and Baxter’s BioPharma Solutions business announced that they agreed to offer a combined approach for the development and production of ADC to simplify the supply chain and provide comprehensive, coordinated and collaborative services for the development, manufacturing, and testing of bulk drug substance and drug product.
Both SAFC and Baxter’s BioPharma Solutions have hands-on experience with more than 20 different antibody-drug conjugate constructs. Each company owns and operates dedicated SafeBridge Certified facilities designed to handle Category 4 compounds. Together the companies offer a complete range of services needed for the development of antibody-drug conjugates. As part of these services SAFC contributes extensive expertise in conjugation and the manufacture of drug linkers, while BioPharma Solutions offers their world-class, sterile fill/finish services for final filling of antibody-drug conjugate products.