Process Development

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.

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.

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, 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^TM).

At IDT Biologika, we leverage the synergies and our more than 100 years of experience in vaccine production for fast and flexible manufacturing of your CGT products.

Upstream

• Research cell seeds and virus seeds
• Transfection and plaque purification
• Cell cloning and cell growth characterisation
• Parameter screening optimization
• Hold time studies / intermediate stabilities

Analytical Services:

• Next Generation Sequencing for Strain Characterization, Genetic Stability, Identity
• Flow Cytometry / Virometry for Virus Quantification & Characterization

Downstream

• Parameter screening and optimization according to technology portfolio
• Hold time studies / intermediate stabilities
• Accelerated stability studies
• Process characterization to support Phase 3 and PPQ
• Scale down / Scale up and process transfer

Analytical Services:

• Chromatography including viral particle AEX for total particle quantitation
• Identity / Purity PCR
• Quantification of virus titer by digital PCR
• Host cell DNA qPCR-Assay and Host Cell Protein ELISA
• SDS-PAGE, Western Blot, Isoelectric focusing
• Virus quantification (plaque assay, TCID50, focus assays; determination by specific or non-specific staining; device-based virus quantification by flow cytometry)

Formulation

• Lyophilization and liquid formulations
• Accelerated stability studies
• Mixing studies
• Investigations of intrinsic/extrinsic particles
• Particle filtration studies
• TOR study and determination of needed overfill

Analytical Services:

• Capillary Electrophoresis
• DLS & MALS for protein and viral particle analysis
• Nanoparticle Analysis
• Disc Centrifuge
• Nano DSF, FTIR

IDT Biologika is licensee of a self-adapted HEK293 cell line in ADCF* medium providing comparable or better AAV and LVV productivity than commercially available HEK293 cell lines.

<small>(ADCF* Animal derived component free)</small>

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.

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

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.