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

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, 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).

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.

See here the strong impact of our vaccine expertise on the development and manufacture of cell and gene products.


Notes: AdV, AAV & LVV produced on HEK293 (typically in suspension, adherent process possible), HSV produced on Vero (adherent), MVA produced on DF-1 (adherent)

Upstream & Downstream Analytical Services

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 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.

 

Formulation Analytical Services

IDT Biologika uses a wide range of different upstream and downstream technologies, formulation strategies and various analytical methods to design the process according to the overall project requirements of the customers.

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
Learn more about our Analytical Development

Technology Platforms

AAV / LVV Platform Technology

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>

The MVA Technology Platform

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.