Poxvirus Production
Poxviruses (including MVA) are suitable as boosters for vaccination and for induction of T-cell immunity in cancer therapies. We design and generate these viral vectors for expression of multiple transgenes. Furthermore, we transfer processes for specific constructs to our optimized and fully characterized production platform.
Generation and Manufacturing of Poxviruses for Vaccines and Virotherapies
Poxviruses carry and express large payloads. They are strong inducers of T-cell immunity and are especially suitable as boosters for vaccination and in virotherapies.
We design and generate viral vectors for expression of multiple transgenes and optimize processes for specific viruses based on our proprietary production platform.
Our rapid recombination system significantly shortens the timelines that are usually required for the generation of recombinant viruses. In a final step, we optimize a production process for your specific virus, based on the fully-characterized, continuous avian cell line AGE1.CR.pIX®.
Based on our Proprietary Technologies
Our poxvirus and MVA technology is based on several unique and protected developments:
- Avian cell line AGE1.CR.pIX, which is highly permissive for a wide spectrum of viruses, including highly attenuated poxviruses such as fowlpox virus, ALVAC, and MVA.
- Chemically-defined culture media for CR.pIX are available in liquid and powder formulation.
- Cultivation and infection of CR.pIX is optimized for scalable, fed-batch suspension processes in conventional bioreactor systems and for intensified processes.
- Purification of MVA is based on filtration without additional chromatographic steps.
- Our unique strain MVA-CR19 replicates to very high titers, even in continuous single-cell suspension culture.
- Our strategy is to maintain multiple expression cassettes in different genomic regions.
- Our rapid recombination method for MVA shortens the process time of generation and purification of recombinants to only 2 weeks.
Suspension Culture Processes
Our suspension-cultivation process in disposable bioreactor systems is robust and fully scalable. The platform ensures efficient cell disintegration for virus release and uses a salt-assisted, filtration-based purification. Host cell-derived DNA levels are significantly below the prescribed limits. We can either produce your drug substance/drug product or out-license the cell line and tech transfer the process to your site.
MVA Vector Design
Our MVA vector design allows for the incorporation of multiple transgenes and provides early high-level expression and superior stability. Characterized by defined modifications, our strain MVA-CR19 provides additional benefits with respect to productivity and potency.With Proven Experience
Our demonstrated experience with recombinant MVA includes the insertion of customized transgene expression cassettes at various positions in the genome, the deletion of host range factors, and the introduction of defined point mutations into viral genes. We design the suitable MVA vector together with you.
With a Fully-Sequenced and Described MVA-CR19
Our MVA-CR19 strain is fully sequenced and described in peer-reviewed publications. It is less dependent on cell-cell contacts for replication and suitable for suspension cultivation processes.
With a Unique Rapid Recombination System
A unique rapid recombination system significantly reduces the time required for plaque purification of recombinant MVA after homologous recombination. This system is particularly suitable for the generation of virus sets with closely related transgenes.
Based on a Fully-Characterised Continuous Avian Cell Line
Our cultivation processes are based on a fully-characterized, continuous avian cell line (CR.pIX), chemically-defined media, and an innovative protocol developed specifically for viruses that replicate by cell-to-cell contact.
Quality Drives Outcome
Across Whole Viral Vectors GMP Life Cycle
Our services comprise everything from the start of your viral vectors GMP life cycle by generation of your MCB and/or MVS either from your cell line or vector platform or out of one of our established MCBs or vectors.
GMP-Compliance
Capability and Scale
Over the expansion of the cells in scales up to 200 L and the production of your vector by either transfection, producer cell line or infection based methods. Depending on the type of virus and cells we are capable of establishing contentious harvest methods over multiple days to maximize yield.
State-of-Art Technologies
Up to the downstream purification of your product with state of the art disposable systems for dead end filtration, tangential flow filtration or chromatographic purification.
Drug Product Filling
At the end of the value chain, the drug substance is refined into a drug product. Our filling process is based on a semi-automated solution (robotic support) in a class A clean room environment. We are capable of aseptically filling the drug product and required diluents into vials with the sizes 2, 6 and 20 mL with a throughput of approx. 200 - 400 vials per hour.
All on One Place
Short distances between our production facility and the quality control laboratories ensure optimal handling and analysis of sensitive viral products and intermediates.
Our Promise To You
Modern and Robust Production Process
- Higher titers compared to conventional production systems
- Process based on continuous cell line instead of embryonated eggs reduces complexity of and required factory footprint
- Filtration-based purification mitigates complex chromatography and supply risks
Reduce Risks to Timelines and Supply
- Costs of goods and risks for drug product release are lower for processes free from animal derived components
- Powdered medium formulation for long shelf life and supply resilience
- Proprietary medium can be produced by different CMOs to limit risks resulting from shifts in CMO or supplier landscapes
Full Flexibility for Scale-up and Commercialization
- Chemically-defined medium for maximum lot-to-lot stability
- Single-cell suspension cultures for effortless scalability, independent of final volume requirements
- Fully-characterized MCB and WCB for a closed production process and controlled risk assessment