15th September 2021 | 2:00pm IST / 4:30pm CST / 9:30am GMT / 10:30am CET
Enzene Biosciences was one of the pioneers in the development of continuous production platforms for the production of biological products. The company has developed several products using its continuous manufacturing platform, which is now being tested in clinical trials. This talk summarizes the lessons learned in developing this platform, from the early stages of development to scaling up and GMP manufacturing. Key areas include the specific challenges of continuous production, such as process optimization, process characterization, automation, process analysis according to the emphasis on plant design considerations. In addition, the elucidation of new opportunities related to lean manufacturing, increased volumetric productivity, reduced production footprint, and the resulting impact on lower COGs will also be discussed, along with a case study on the factors of the conversion process. Batches are made during an infusion process. The discussion ends with a summary of the main factors that led to the emergence of continuous production as the preferred production platform for the production of organic products.