Baxter's BioPharma Solutions business and Sigma-Aldrich Corporation's SAFC Commercial custom manufacturing services business unit have established a collaborative manufacturing agreement for antibody drug conjugates (ADCs).

SAFC will contribute expertise in conjugation and the manufacture of drug linkers while Baxter BioPharma Solutions will offer sterile fill/finish services for final filling of ADC products.

Dedicated project managers at each site will work closely together to help ensure a consolidated timeline and a transparent transfer, with a primary project lead identified as the main contact as mutually agreed. The bulk drug substance conjugated by SAFC will be transferred directly to Baxter's project management team using established protocols. The Baxter team will then work to provide the correct filling, regulatory testing and validation, packaging, and import/export paperwork processing as well as product lot approval for distribution.

Source: Baxter BioPharma Solutions