OEM Case Studies

 

Blood Typing Case Study

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The OEM Project Situation
A Blood Typing company was going through the process of expanding its portfolio of blood typing platform assays to further penetrate the market. In order to optimize the use of its resources, its overall costs, the quantity and the speed of such an expansion, the client company is looking for a trusted OEM partner to co-develop and manufacture a portion of its finished products.

Merck's Operational Support
For more than 30 years, Merck has been the leader in the development of monoclonal antibodies for the blood grouping market and offers the largest selection of human IgM monoclonal antibodies against red cell antigens available today. Moreover, Merck's ISO-certified and FDA-licensed, state-of-the-art cGMP manufacturing facilities and experienced personnel enables them to stay in the forefront of this industry.

The Customized Solution
Merck established a dedicated team of serology experts to work closely with the Blood Typing Company and built a trusted, consultative partnership throughout their product expansion process. Using a range of monoclonal antibodies in various forms, including standardized intermediates, For Further Manufacturing Use (FFMU), along with finished bulk reagents, and customer-specific packaging, Merck provided a customized solution tailored to the client's strict requirements.

Results
The Blood Typing company selected a range of rare finished reagents from Merck to add to their own product portfolio. In addition, two new assays were developed in collaboration with Merck. All products were vialed, packaged and labeled with the client's name and trade dress. Merck also offered regulatory assistance with product and batch registration which enabled the company to sell these products into several global markets. To further solidify the relationship between the two companies, long-term supply and quality agreements were instituted. The client benefited immensely from this partnership and was able to increase their market share and stay ahead of the competition.

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