Baxter’s BioPharma Solutions and Sigma-Aldrich Corporation’s (SAFC) commercial custom manufacturing services business unit 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.

Customers need flexibility, reliability and quality from their contract manufacturing organisation (CMO), and many expressed the need for a single solution for ADC development.

The partnership brings two leading providers of critical-care products and services together to provide customers with a secure and simplified supply chain, and assisting them in getting ADC products to the market faster.

Baxter BioPharma Solutions provides scientific expertise, sterile contract manufacturing solutions, parenteral delivery systems, and customised support services for commercialisation by pharmaceutical companies.

SAFC offers a unique product and service solution for customers looking to take their conjugate therapeutics from clinical phases into commercialisation.

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 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, validation, packaging, and import/export paperwork is processed, and the product lot is approved for distribution.