Oncolytic virus manufacturing platform services with experience producing vaccinia virus, adenovirus, and herpesvirus oncolytic vector systems.
As a leading oncolytic virus CDMO, we support seed virus production, tech transfer, process and analytical method development, clinical GMP manufacturing, and aseptic fill and finish.
In addition, we offer production of qualified GMP cell banks (and GMP plasmids, if required) to support GMP oncolytic virus manufacturing. Our extensive analytical and regulatory capabilities offer additional support for oncolytic process development, scale-up, and GMP-readiness to ensure effective product release and regulatory filing.
We offer a full suite of in-house oncolytic virus QC release tests. uBriGene’s analytical teams can support development of virus specific analytical assays.
| Services | Estimated Timeline | Price |
|---|---|---|
| Research grade & preclinical oncolytic virus productions | 2-3 Weeks | Please Inquire |
| GMP grade oncolytic virus process development, production, and QC testing | Please Inquire |
*Outsourced testing
Comprehensive oncolytic virus CDMO services
Client oriented partnership
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Oncolytic virus manufacturing comprises virus amplification and purification, often involving transduction of host cells with seed viruses and expansion to target scale. After cell lysis and clarification, many oncolytic viruses are purified with density gradient ultracentrifugation, anion exchange (AEX), or size exclusion chromatography. The final oncolytic viruses are formulated using Tangential Flow Filtration (TFF).
Diagram of CAR-T/CAR-NK gene modification tools. Plasmids, RNA-LNP (including mRNA, circRNA, and saRNA LNP), lentiviral vectors, and CRISPR gene editing may be used to genetically modify T cells and NK cells, producing the final CAR-T and CAR-NK for therapeutic applications.
Request a quoteWe offer a full suite of in-house oncolytic virus QC release tests. uBriGene’s analytical teams can support development of virus specific analytical assays.
| Testing Items | Method | |
|---|---|---|
| Physical/Chemical Properties | Appearance | Visual inspection |
| pH | pH measurement | |
| Identity | Sequencing | Sanger/NGS |
| Target Protein | Western Blot | |
| Morphology and Structure | EM | |
| Titer | Genome Titer（vg） | qPCR |
| Infectious Titer（PFU） | Plaque Assay | |
| Purity | Purity | AUC |
| Potency | Target Cell Killing | CCK8 assay |
| Tumor Specificity | CCK8 assay | |
| Virus Replication | Plaque Assay | |
| Target Protein Expression | WB/ELISA | |
| Residuals | Host Protein Residuals | ELISA |
| Host DNA Residuals | qPCR | |
| Nuclease Residuals | ELISA | |
| E1A Residuals | qPCR | |
| Safety | Sterility | Membrane Filtration |
| Mycoplasma | qPCR | |
| Wild Type Virus | Sanger sequencing | |
*Outsourced testing
Our GMP CAR-T and CAR-NK manufacturing platform leverages lentivirus and CRISPR gene editing to generate targeted therapies. Our approach begins with the receipt of leukapheresis products, followed by the enrichment and activation of target cell populations. We then proceed with genetic modification via lentiviral transduction or RNA, ensuring precise expression of chimeric antigen receptors (CARs).
After transduction, the modified CAR cells undergo expansion in bioreactors or culture bags to achieve a sufficient quantity for treatment. The process concludes with washing, harvesting, formulation, and cryopreservation, maintaining sterility through aseptic filling techniques. Comprehensive quality control tests are conducted throughout to ensure compliance with GMP standards. Additionally, our platform includes the optimization of protocols to improve process closure and adaptation from academic or research-grade processes to GMP standards.
Fig. 1. Adenovirus (AdV) elution profile after AEX chromatographic purification
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Fig. 2. Vaccinia virus elution profile after SEC purification
Request a quoteDiscover how uBriGene collaborated with a client to develop processes and manufacture vaccinia virus.
Discover our GMP plasmid manufacturing process and testing.
Unveil the current manufacturing approaches for LVV and its deployment in cell therapies.
Learn about CAR-T production process & regulatory guidelines.
The production time for MVB preparation is around one month for oncolytic virus production.
The final yield of GMP oncolytic virus manufacturing is around 30%.
Yes, as an oncolytic virus CDMO provider, uBriGene provides oncolytic virus manufacturing from research grade to full GMP grade. We can also support developing processes and analytical methods.
Oncolytic virus therapy involves using genetically modified viruses to target and destroy cancer cells without harming normal cells. These viruses can also stimulate the immune system to attack tumors.
We specialize in the production of various oncolytic viruses, including adenovirus, herpes simplex virus, and vaccinia virus. Our team has extensive experience, with over 10 batches of GMP vaccinia virus production completed.
We offer a wide range of host cell lines, including both adherent and suspension cells, to accommodate different virus types and production needs.
Our scalable production processes support volumes up to 200L, ensuring flexibility from small clinical batches to larger commercial-scale manufacturing.
We operate under a robust Quality Management System (QMS) and comply with FDA, EMA, and NMPA requirements for GMP production. Our comprehensive in-house quality testing ensures that all products meet the highest standards.
Our platform technology includes cell and virus banking, master and working cell banks, optimized upstream and downstream processes for efficient and streamlined production, and sterile fill & finish.
Yes, we provide end-to-end support, from cell and virus banking to scaled GMP manufacturing, and regulatory assistance for early discovery through to clinical and commercial stages.
Take the next step in your CAR journey. Discuss your project requirements and see how our CAR-NK & CAR-T CDMO services can support your goals.
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Ask the plasmid DNA expert! With over 300 GMP batches in our track record and our cost-effective platform technology, we can help accelerate your clinical programs.
