Date: 2014-09-24
Type of information: Production agreement
Compound: antibody drug conjugates, drug linkers
Company: Sigma-Aldrich\'s SAFC (USA - MO) Baxter (USA - IL)
Therapeutic area: Technology - Services
Type agreement:
Action mechanism:
Disease:
Details: * On September 24, 2014, Sigma-Aldrich Corporation’s SAFC® Commercial custom manufacturing services business unit, and Baxter’s BioPharma Solutions business have established a collaborative manufacturing 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. SAFC offers a unique product and service solution for customers looking to take their conjugate therapeutics from clinical phases into commercialization. Baxter BioPharma Solutions provides scientific expertise, sterile contract manufacturing solutions, parenteral delivery systems, and customized support services for pharmaceutical companies’ commercialization efforts. 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 SAFC and Baxter. Dedicated project managers at each site 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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