Baxter’s BioPharma Solutions (BPS) business and Sigma-Aldrich Corporation’s SAFC® Custom Manufacturing Services business unit, have established a collaborative manufacturing agreement. As part of the terms of the agreement, SAFC will contribute extensive expertise in conjugation and the manufacture of drug linkers, while BioPharma Solutions will offer world-class, sterile fill/finish services for final filling of Antibody-drug Conjugate (ADC) products.
Antibody-drug conjugation technology uses monoclonal antibodies or other biologics to deliver conjugated Highly-Active Pharmaceutical Ingredients or HAPIs to a specific target. In conjugated form, these new drug exhibits more selective cytotoxicity, which results in sparing non-target cells from many of the unwanted toxic (side) effects. New ADCs that are being developed are more targeted and exponentially more powerful.
In today’s market, pharmaceutical industry customers require flexibility, reliability and quality from their Contract Manufacturing Organization (CMO). Industry watchers confirm that many industry players also expect a single solution for their ADC development.
The collaboration between Baxter and SAFC brings two providers of critical-care products and services together to provide their customers with a secure and simplified supply chain, as well as a comprehensive, coordinated and collaborative services for the development, manufacturing, and testing of bulk drug substance and drug products. Both companies have hands-on experience with more than 20 different ADC constructs. The companies have also dedicated facilities that are SafeBridge Certified to handle Category 4 compounds, allowing them to get Antibody-drug Conjugate products to the market faster.