Time and effort spent on key areas of the process is critical when planning to produce material in larger quantities for later phase trials. Optimizing yields and productivity from upstream and downstream steps will lead to lower production costs and a faster route to commercial supply. A good process is characterized by reproducibility, robustness, high yields both in terms of process time and scale of manufacture (time-space yield) and quality, followed by transferability, scalability and affordable costs.
The processes we develop on behalf of our customers are GMP compliant. We ensure that all materials and equipment are fit for purpose and can be used as the process moves forward for GMP manufacture. The process development stage is also important for establishing the relevant in-process controls and analytical tools required for release of the final product. Vibalogics brings a wealth of experience in suggesting the most relevant assays to characterize your product whilst remaining relevant to the clinical stage of the project.