Facility Startup

Greenfield Process Engineering, C&Q and Compliance Support Kymanox consists of a diverse team with a broad range of experience and expertise that allows us to support facility start-up projects from conception to completion. We work with our clients to provide tailored support that meets their specific needs as well as applicable regulatory requirements. We have a diverse team with engineering, …

3 Assay Development Rules for Tech Transfer

At Kymanox, we get to see a lot of processes that are being developed for commercial approval. One of the biggest problems we come across on our projects is related to analytical assays. On fast-tracked tech transfer and scale-up projects, assay development – including qualification, transfer, and validation – are almost guaranteed to be rate-limiting for the overall project schedule. Assays come in a lot of …

Better Technology Transfer for Faster Growth

In Pharma manufacturing, transferring a process from location A to location B or company A to company B (e.g., to a CMO) is a natural result of scale-up, scale down, and the process lifecycle. The transfer must be done right to meet regulatory requirements in New Drug Applications (NDAs) or Investigational New Drug (IND) applications. From a business perspective, any …