09.25.14
Sigma-Aldrich’s SAFC Commercial custom manufacturing services business unit and Baxter BioPharma Solutions have established a collaborative manufacturing agreement under which SAFC will contribute expertise in conjugation and manufacture of drug linkers and Baxter will offer sterile fill/finish services for final filling of ADC products.
The collaboration brings together critical-care products and services aimed at providing customers with a secure and simplified supply chain to get ADC products to the market faster.
SAFC and Baxter will provide support and dedicated project managers at each site to help ensure a consolidated timeline and a transparent transfer. 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.
The collaboration brings together critical-care products and services aimed at providing customers with a secure and simplified supply chain to get ADC products to the market faster.
SAFC and Baxter will provide support and dedicated project managers at each site to help ensure a consolidated timeline and a transparent transfer. 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.