IDT Biologika - Process Development Service

Finding the Optimal Solution
Our Process Development Team comprising scientists and engineers highly experienced in complex upstream and downstream processes and formulation to speed up clinical development and time to market. We help our customers overcome challenges with their products by defining the appropriate technologies and employing our experience to define a process that works best and can be scaled. For this, we can choose between different analytical methods and a 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.

• CUSTOMER TECHNOLOGIES
• UPSTREAM PROCESS
• DOWNSTREAM PROCESS
• FORMULATION DEVELOPMENT

Technology Transfer Teams
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.

Upstream & Downstream Technologies
To accommodate the individual nature of each customer’s project, we offer multiple technologies, both for upstream and downstream processes. In upstream, we have the iCELLis® bioreactor system (nano and manufacturing scale), which provides excellent cell growth conditions for adherent cells. It can be fully automated and is easily scaled up, contributing to robust processes in both development and ultimately manufacturing. In addition to iCELLis® technology, we offer CellStacks and HyperStacks systems, Wave Bioreactors, and disposable stirred bioreactors, Roller Bottles – thus enabling suspension and adherent cell cultures. For process characterization studies, we can run automated small-scale upstream studies in parallel.

In downstream, the IDT Biologika Development Team has broad expertise and an extensive track record with Tangential Flow Filtration (TFF), UF/DF and several chromatography systems (e.g. ÄKTA).

Formulation Development
At IDT Biologika, we support frozen, liquid, and lyophilized formulation development. Our Formulation Development Team offers a broad range of technologies to characterize stability, aggregation, particle size and particle size distribution.