Madhava Ram Paranandi, Sr. Director, MSATM Scale-up of a cell culture process is seldom straightforward, more so when scaling up for the first time in a new facility. The recipe for a successful scale-up includes a thorough understanding of the cell culture process, manufacturability of the process at scale, well-characterized bioreactors and efficient utilization of the available scale-up principles. Being a contract manufacturing organization, we have worked, and continue to work on different projects from different customers each with its own set of challenges. To tackle these distinct chal ..read more

With the recent advances in biotechnology, there has been a considerable need for faster and more efficient development of biotherapeutics and their approval process. This translates to shorter process development timelines for both upstream and downstream operations. As CMOs it becomes very essential to develop a platform approach involving a high throughput screening technology for evaluating multiple conditions for process optimization considering scalability along with manufacturability. With the development of small-scale multi-parallel bioreactor systems leading to screening of several h ..read more

Kemwell, a leading contract manufacturing organization, has been working on projects from different customers, each with its own set of challenges. To tackle these distinct challenges it is important to have a holistic approach to scale-up. The recipe for successful scale-up of a mammalian cell culture process is provided in the figure below. Well characterized bioreactors: With the variety of processes we encounter, it is imperative that we fully understand the capability of our bioreactors from bench-scale to large scale. All bioreactors at Kemwell are therefore characterized thoroughly for ..read more