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Case Study

The 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. 

Our Operational Support

For more than 30 years, we have 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, our 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

A dedicated team of serology experts was established 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, we provided a customized solution tailored to the client's strict requirements. 

Results

The Blood Typing company selected a range of rare finished reagents to add to their own product portfolio. In addition, two new assays were developed. All products were vialed, packaged and labeled with the client's name and trade dress. Regulatory assistance was also provided 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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