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Overcoming Challenges Together

Spain - May 26, 2020

Biokit’s IVD biomaterials manufacturing capabilities can be fitted to our partners’ needs

Today and in the coming years, due to the changing market, major IVD players will have to meet the increased demand for IVD products while remaining innovative, reliable, and focused on quality.

Our experience in immunoassay development and manufacturing helps us to understand the challenges you might face as an immunoassay manufacturer when you have to adapt to an increase in demand, either for the final immunoassay or for the key IVD biomaterials, such as antigens and antibodies.

Our routine manufacturing currently includes several different monoclonal antibodies (mAb) that mainly go on to be used as the key IVD biomaterial in different commercial immunoassays for a variety of medical conditions.

In Biokit, we work alongside our partners to help them meet their operational and quality needs.

Our approach

One of the immunoassays that we are manufacturing for one of our partners has experienced a significant growth in demand during recent years. This increase in demand has also resulted in a remarkable increase in the need for the monoclonal antibody used for this immunoassay. Our operations team has worked to scale-up the cell culture, optimizing the entire manufacturing process to increase the production of this mAb. This process has been carried out with a focus on keeping the quality attributes unaltered and, more importantly, on maintaining the supply of the immunoassay in accordance with our partner’s performance and quality expectations and needs.

IVD Manufacturing Capabilities

Outcomes

One result of the cell culture scale-up and optimization of the manufacturing process has been a 245% increase in the amount of mAb manufactured over three years.

This increase in the quantity of monoclonal antibody manufactured has allowed our partner to meet the increase in demand from their customers while maintaining their performance and quality levels.

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