OEM Case Studies

The OEM Project Situation
A well-known IVD kit manufacturer, specializing in immunoassay-based solutions, was facing a serious issue with the production of a critical primary antibody. Although the clone and the cell banks were not impacted, a high capacity bioreactor became defective and needed repair. Already low on their existing inventory of antibodies and knowing they would not be able to cover expected demand, the manufacturer's QC, R&D and Manufacturing personnel decided to explore outsourcing options in order to maintain production continuity and secure supply of this critical component.

Merck's Operational Support
Contract manufacturing services provided by Merck offer many advantages in this type of situation, and can be an ideal solution for any kind of production issue the client may face. In this instance, a dedicated team of Merck technical experts covering all areas of production, development, quality assurance and regulatory compliance worked closely with the IVD manufacturer to develop a customized solution in a timely manner.

The Customized Solution
The cell line transfer and antibody validation was performed according to a detailed project charter and was managed in compliance with Merck's Quality Management System. With fermentation volumes ranging from 1 Liter to 5,000 Liters, Merck was able to manufacture the antibody at a batch size commensurate with the customer's own process. Throughout the project's duration, the manufacturer was kept informed of progress and was invited to regularly visit Merck's ISO and GMP-certified production facility. Validation of the critical antibody was successful and all regulatory requirements were met, allowing Merck to start routine production before the manufacturer's own stock of antibody was depleted.

Results
The IVD manufacturer was able to avoid disruption in production of their critical raw material by utilizing Merck's contract manufacturing capabilities. Since the success of this initial project, the manufacturer has begun employing Merck as a secondary source for the production of other critical primary antibodies, thus ensuring an alternative source of supply. This will help significantly lower future risk of production interruptions, and secure business continuity within a highly complex biotech industry.

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