Enabling Purification Solutions - Scalable Target Production Specifications

In development, time to develop a scalable process and the resulting target product (bulk) specifications are often the two most important parameters in the race to develop products rapidly for first clinical trials and beyond. Ideally a suitable target specification that will sustain all stages of clinical development and regulatory assessments is sought for. Often process constraints on yield do not allow setting suitable stringent specifications in early development, bearing the inherent risk of having to bridge early preclinical development with older product with newer product.

The ContiChrom platform allows developing fast a scalable process in one shot with suitably stringent product specifications that will hold until the granting of marketing authorization without having to re-develop processes or perform bridging studies.

For biologics, product and process are intertwined and not separable, both have to be set and fixed early in development. The solution of the combination of such constraints is usually only possible after lengthy process development. With MCSGP this is achievable in a much shorter time. The figure below shows a picture on the time and quality advantage of MCSGP versus classical batch.

(click to enlarge)