Development of Manufacturing Processes
Manufacturing biopharmaceutical products means appropriate utilization of living systems for their manufacturing.
JAFRAL’s process development platform starts with preparation of Cell and Virus Banks at research level, which are appropriately characterized. This then used for all laboratory scale upstream and downstream development work.
JAFRAL performs small scale development in order to assure that process is robust, repeatable and scalable. Within these activities critical process parameters are defined, which enable successful scalability to 10L, 20L or 50L scale.
Initial process development work also includes small scale formulation studies that are coupled with stability studies at non-GMP level.