For customers who are already in later clinical stages when they come to IDT Biologika, one of our focused areas of expertise is conducting process transfers. For this, our Development and Manufacturing Teams again join forces to ensure a seamless transition between sites through a pre-defined set of confirmation and engineering runs.
IDT Biologika’s Global Development Team is exceptional at finding the best way to develop and characterize our customers’ processes. We bring unparalleled experience and expertise in the vaccine area, always aiming at maximizing business value through optimizing yields, quality and potency suitable to meet regulatory and clinical requirements.
Finding the Optimal Solution
In both process development as well as in analytics, we are always striving for the best possible solutions for customers and to speed up clinical development and time to market. In early-stage projects, the ability to choose between different technologies and exercise freedom in finding the best options while strictly focusing on manufacturability and scalability criteria from the very beginning is a significant advantage. We can choose between different analytical methods and broad range of different upstream and downstream technologies as well as formulation strategies to really design the process according to its overall project needs.
Once we have developed a process, we are able to transfer it into GMP very smoothly and quickly to produce the first clinical batches. It is truly a very seamless transition as our Development and Manufacturing Teams are working closely together – before, during and after transfer. Once a customer is successful in clinical phase I or II, the advantage with IDT Biologika is we are integrated, thus being able to take over process characterization efforts including DoE based process parameter design studies, and support of process performance qualification runs to prepare for commercial production and launch.