Sigma-Aldrich's SAFC Commercial custom manufacturing services business unit has agreed a collaborative manufacturing agreement with Baxter's BioPharma Solutions business to offer a single solution for the development of antibody drug conjugates (ADCs).
SAFC will contribute its expertise in conjugation and the manufacture of drug linkers, while BioPharma Solutions will offer sterile fill/finish services for final filling of ADC products.
No financial details have been revealed.
SAFC offers a product and service solution for customers looking to take their conjugate therapeutics from clinical phases into commercialisation, while Baxter BioPharma Solutions provides scientific expertise, sterile contract manufacturing solutions, parenteral delivery systems, and customised support services for the commercialisation of pharmaceuticals.
Through this agreement, the companies will work to create a seamless contract manufacturing environment that supports customers navigating the complex challenges of ADC development.
Customers taking advantage of this collaboration will have streamlined support from both companies. Dedicated project managers at each site will work closely together to 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 ensure the correct filling, regulatory testing and validation, packaging, and import/export paperwork is processed and the product lot is approved for distribution.
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