Optimisation
Once the technology has been transferred, our scientists, led by the project manager, will strive to optimise the existing process to increase yield, decrease time and cut down cost of production.
The optimisation also consists in making sure that all ingredient and steps used in the existing process are compatible with regulatory requirements.
The optimisation also consists in making sure that all ingredient and steps used in the existing process are compatible with regulatory requirements.
Scale-Up
With an optimised cell culture process, the manufacturing staff will scale the process up to the desired clinical batch size.
Bio Elpida is able to produce clinical trial material and small scale commercial batches. We have a track record of clinical batches produced for all clinical stages (from early phase I to phase III clinical trials) in Europe or in the US.
Bio Elpida is able to produce clinical trial material and small scale commercial batches. We have a track record of clinical batches produced for all clinical stages (from early phase I to phase III clinical trials) in Europe or in the US.