Improve productivity and reliability of your critical upstream operations by investing in the right cell culture technology solutions
What does it take to get a new biotech drug to market? The process development starts with culturing cells and requires the right technology to reliably and efficiently produce them. In addition, a capability to seamlessly move out of process development, into clinical trials, and from small to large-scale cGMP manufacturing, is essential.
The cell culture process requirements for biotechnology drugs have become increasingly challenging, with a drive for process intensification. Fed-batch, perfusion or continuous cell cultivation strategies are increasingly used to maximize productivity, leading to a growing demand for new approaches to bioreactor design, improving aeration and mixing, and to cell culture feed solutions.
Newer classes of therapy, such as cell and gene therapy, are now starting to show considerable promise; with the number of entities entering into clinical trial phases increasing significantly. Established laboratory scale approaches to cell culture start to be questionable when moving into clinical manufacturing that require cGMP with appropriate closed, automated and scalable systems. Scale is particularly important as therapies move into phase II and beyond, as batch sizes vary widely, depending on the number of patients and the dose required per patient.
When large quantities of adherent cells are needed, scaling out 2-dimensional cell growth systems like roller bottles and cell factories quickly limits possibilities, as they need a lot of manual operations. This makes them prone to high risk for contamination and other user errors. These systems don’t offer any cell culture monitoring options either, and thus, miss opportunities for control and automation, necessary for cGMP manufacturing.
The question often arises whether to change to suspension cell culture for growing cells to meet large-scale manufacturing demands. This requires either adapting the adherent cells to suspension, or moving to a different expression system. These changes are not trivial and can influence product quality, yield, cost and acceptance by regulatory agencies, all of which can have a serious impact on project timelines and budgets, and ultimately time to market. An alternative would be to scale-up the adherent cell process in well controlled, automated, fixed-bed bioreactors, or by using suitable microcarriers in stirred-tank production systems.
Regardless of what your path is, at Pall we have the right cell culture solution for you and your process. Our technologies are the complete and integrated solutions that increase your upstream process performance, while adding operational simplicity and improving reliability; whether you are growing adherent cells or suspension cells for gene therapy, cell therapy, vaccine or monoclonal antibody (mAb) manufacturing.