White Paper: Consistency In Raw Material Supply: Benefits Of Partnering With A Customer-Centric Supplier

Biopharmaceutical manufacturing processes today are critically dependent upon the ability of suppliers to provide consistent, on-time supply of quality raw materials. Therapeutic manufacturers are increasingly concerned about potential downtime associated with underperforming materials and are consequently looking for customer-centric suppliers who can help develop collaborative solutions that meet a variety of supply chain challenges.

The Challenge
A therapeutics manufacturer discovered lot-to-lot variations during production through in-process testing. Further manufacturer analysis revealed that the root cause was disparities in purity among lots of Bis(2-hydroxyethyl) amino-tris(hydroxymethyl)methane (Bis-Tris) from their original supplier. These variations in raw material were adversely affecting quality and yields of their finished product lots. To resolve this issue, the manufacturer wanted to 1) find a supplier who could consistently provide raw materials that met their quality requirements and 2) identify a secondary supplier to limit risk from being sole-sourced.

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