Time to Market
Cellca possesses unique expertise in developing high producer cell lines, fulfilling the highest industrial standards. Each producer cell line is delivered with optimised process parameters on a 100 litre scale to ensure fast and reliable transfer into a manufacturing plant. During cell line generation, media development and upstream process development, comprehensive protein analytics are performed with our partner to ensure the desired protein quality.Speed is key: Our proprietary expression system allows the generation and isolation of high producer cells in a short time. The technology modules are fine-tuned for maximum performance. Generated cells are placed in generic process conditions to save time. The whole process from vector construction through to bioreactor harvest is serum-free, so that time-consuming process steps are omitted, such as adaptation of cells into serum-free conditions.
Risk assessment approach: Robustness and reliability are keys for industrial manufacturing. Therefore we perform an intensive risk analysis by evaluating each critical process step. For example, different cell clones, different culture media and process conditions are examined with protein analytics. We evaluate the genetic stability of the production clone and perform scale-up simulations. Finally, we deliver a scalable high-titre process matching the client's protein specifications.
Efficiency: Our integrated solution achieves multigramme expression levels of antibodies in scalable fed-batch processes.
Non-GMP protein production: During small-scale process development we provide you with 10 to 50 g of your protein. Protein production can be accomplished either in a stirred tank or in a disposable bioreactor. This quantity of protein can be purified in cooperation with our partner Rentschler Biotechnologie GmbH (GER) and delivered in order to support clients' in-house experiments.