Biokit partnered with an IVD company to scale-up the production of a critical biomaterial for an IVD assay.

Recent improvements in healthcare access have led to an increase in demand for in-vitro diagnostic testing which impacts the supply chain. In order to keep up with the rising demand for IVD assays, manufacturing capabilities, especially those related to critical biomaterials, should be adapted to scale-up the process.

In Biokit, we work alongside our customers in order to overcome challenges such as increases in demand for critical biomaterials and to simplify the supply chain. 

Our Approach

In this case, the biomaterial was expressed in E. coli, which continues to be a widespread expression system thanks to its low cost, rapid culture times and high biomaterial yield. However, when scaling-up, an optimization process is needed in order to improve productivity and streamline supply chain operations.

A multifunctional team including R&D, Operations and Quality works by following a given methodology in order to fulfil customer needs.

Outcomes 

The result of this process was an increase in production by 100×, and a 12-hour reduction in culture time (from 16 h to 4 h). Moreover, the supply chain has been streamlined thanks to obtaining bigger single batches, which reduces the number of shipments and income controls from our partners.