Newly acquired Sigma-Aldrich’s SAFC custom manufacturing services business unit will provide expertise in conjugation and the manufacture of drug linkers while Baxter’s BioPharma Solutions business will offer sterile fill/finish services for final filling of ADC products.
The collaboration will allow biopharma customers to get ADC products to market faster, the companies claim.
SAFC’s offering will help customers looking to take their conjugate therapeutics from clinical phases into commercialization, while Baxter, which recently announced plans to spin-off its biopharma assets under the name Baxalta, provides scientific expertise, sterile contract manufacturing solutions, parenteral delivery systems, and support services for pharmaceutical companies’ commercialization efforts.
The bulk drug substance conjugated by SAFC will be transferred to Baxter’s project management team using established protocols, and the Baxter team will then work to ensure the correct filling, regulatory testing and validation, packaging, and import/export paperwork is processed and the product lot is approved for distribution.
SAFC did not respond to a request for comment by press time.