Process Development to Scale Up

Process Development to Scale Up

Not all CMO’s are created equal, and it’s not just about manufacturing assets. Yes, these are important, but equally important is a strong process-development expertise to support manufacturing.

At Kingchem, we understand how critically important process development is to the success of your product, and to the success of our company. Our Dalian R&D facility has state of the art capabilities and experienced Ph.D. level scientists who ensure all of our processes are successfully scaled into our manufacturing plants.

We pride ourselves not only in developing robust and reproducible manufacturing processes, but also in understanding the challenges of the pharma industry — namely, that strong fundamentals in ‘Quality by Design’ are a requirement.

We know that the issues facing the industry around regulations and guidances such as Q11 require that a fundamental understanding of the impact of impurities on the API quality are of the utmost importance. Our scientists, both analytical and process, have the tools and expertise to understand the issues related to fate-and-purge of impurities, as well as high level structural elucidation.

Let us tell you more about our Process Development capabilities through this contact page.