What does it take to bring a new biotech product to market? Process development starts with cell growth and requires the right technology to produce them reliably and efficiently. The ability to seamlessly transition from process development to clinical trials and small- and large-scale cGMP manufacturing is essential.
Bioreactors have been an important part of the cell culture process and present challenges when it comes to transitioning from PD to cGMP production. About 25 years ago, the first disposable bioreactors were introduced. Since then, the development of disposable technology has brought many benefits, such as closed series irradiated bio containers and scalable systems. As a result, disposable bioreactors are increasingly used for small, medium, and large productions.
In this webinar, we present case studies that illustrate the benefits of using industry experts, best practices, and integrated energy solutions to design a robust, scalable, and reproducible process.
What is upstream processing (USP)?
The upstream part of a bioprocess refers to the initial stage where microbes/cells are cultivated, e.g. bacterial or mammalian cell lines in bioreactors. Upstream processing includes all stages associated with inoculum development: medium preparation, cell culture, cell separation, and collection. When cells reach the desired density, they are collected and moved to the downstream part of the bioprocess.