Process Development

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.

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

Formulation Development

Technology Platforms

VERO Cell Production Platform Technology

For human vaccine production, IDT Biologika can provide a VERO cell production platform to customers. MCB, WCB and EOP of the VERO (WHO) cell line have been fully characterized according to EP, CPMP, FDA Guidance for Industry and PTC Guidelines.

For small-scale trials and scale-down modeling, iCELLis® nano units are available. The upstream scale is available up to 500m² using the iCELLis® 500 fixed-bed bioreactor. Depending on the nature of the customer virus, the downstream platform can be easily adapted to speed up virus-specific downstream optimization.

The MVA Technology Platform

IDT Biologika is considered the global leader in Modified Vaccinia Ankara (MVA) and recombinant and non-recombinant poxvirus technologies.

DF-1 Platform
Chicken embryo fibroblast continuous cell line
At Dessau (Germany), the DF-1-based MVA platform (developed by IDT scientists) is established on the CellStacks 40 scale.

IDT Biologika has developed an innovative technology platform for MVA (Modified Vaccinia Ancara virus) production that is offered to our customers. It uses the continuous cell line DF-1, a chicken cell substrate for CEF-adapted vaccine viruses. The cell line is spontaneously immortalized, not transformed, and free of endogenous retroviral activity.

DF-1 is permissive for a range of avian viruses, Vaccinia viruses, Morbilliviruses, VSV, and Orthomyxoviruses. MCB, WCB and EOP of the DF-1 cell line have been fully characterized according to EP, CPMP, FDA Guidance for Industry and PTC. Manufacturing is established at CellStacks 40 scale and provides an efficient downstream process.