CAR-T and CAR-NK manufacturing workflows with qualified raw materials and gene-modification platforms, meeting the highest regulatory standards.
Our GMP workflows support the manufacturing of CAR-T and CAR-NK therapies. With extensive experience in GMP manufacturing and release, our skilled technical and regulatory teams ensure compliance with FDA, EMA, NMPA, Health Canada, and TGA standards.
Consult with us for seamless IND submissions, regulatory compliance, and cutting-edge technology in CAR-NK and CAR-T CDMO manufacturing services.
Sit aliquam elit vitae bibendum lectus blandit dictum. Nisi porta elementum sed diam eleifend pellentesque. Quis aenean quam.
Request a Quote
Optional caption section: This caption text can be used under any image or content block as-needed. Use cases are figure legends, citations, image descriptions
Optional caption section: This caption text can be used under any image or content block as-needed. Use cases are figure legends, citations, image descriptions
Automated closed-system technology for manufacturing ensures sterility with functionally closed disposables, minimizes operator errors through pre-programmed steps, and enhances consistency by reducing variability. It also reduces technician hands-on time and lowers production costs.
These advantages not only improve the efficiency and reliability of the manufacturing process but also ensure a more cost-effective production of cells.
Our mature, 3rd generation lentivirus platform offers client access to qualified 293T cell banks and FDA-registered helper plasmids, accelerating development and manufacturing. We also offer multiple RNA platforms for CAR-T and CAR-NK products, including mRNA, circRNA, and saRNA LNP manufacturing.
Our analytical teams develop and perform potency assays and LVV/RNA-specific methods, routinely releasing GMP products with in-house assays. Additionally, our GMP plasmid platform efficiently and cost-effectively produces all necessary lentivirus plasmids or RNA templates.
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 quoteOur 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.
Request a quoteuBriGene provides in-house and custom assays for CAR-T and CAR-NK process development, including QC release and stability tests. Our CAR-NK and CAR-T CDMO services ensure safety, efficacy, and consistency through rigorous quality assurance and control, adhering to the highest industry standards.
| Test Items | Method | |
|---|---|---|
| Identity | Sanger sequencing | |
| Physical /chemical properties | Appearance | Visual inspection |
| pH | pH measurement | |
| Osmolarity | Freezing-point depression test | |
| Strength | Cell viability | Cell counter |
| CAR transduction efficiency | Flow cytometry | |
| Cell killing assay | Flow cytometry | |
| CAR copy number | qPCR | |
| Purity | BSA Residuals | ELISA |
| E1A residuals | qPCR | |
| SV40 residuals | qPCR | |
| RetroNectin residuals | ELISA | |
| Magnetic beads Residuals | Microscopy | |
| Bovine serum albumin residuals | ELISA | |
| Safety | Endotoxin | Gel-clot assay |
| Sterility | Membrane filtration method | |
| Mycoplasma | Culture method | |
| Replication competent virus | PCR | |
*Outsourced testing
uBriGene's CAR-NK and CAR-T CDMO services are highly customizable to meet specific therapeutic needs. Our approach includes:
Tailored Process Designs: Customized for optimal performance and efficacy.
Flexible CAR Delivery: Options include plasmid DNA, LVV, RVV, mRNA/LNP, and gene editing.
Comprehensive Testing: Ensuring quality and safety with CAR gene identification, transduction efficiency, potency testing, and sterility checks.
The advantages of membrane matrix in downstream chromatography for plasmid purification include requiring only 30% of the time compared to conventional resin. Therefore, plasmid DNA is manufactured faster and at a much lower cost.
Rhoncus duis elementum suspendisse odio amet arcu tellus. Sapien felis vestibulum euismod eget orci scelerisque id. Non ut sagittis leo et. Et pretium nisl ultrices dapibus sit euismod volutpat elementum.
Symptom Onset: 2015
Clinical Diagnosis: Refractory relapsed Hodgkin’s lymphoma, CD30 positive.
Treatment: Autologous anti-CD30 CAR-T cell therapy.
Clinical Efficacy: Complete remission 1.5 years post-infusion. The patient returned to a high quality of life 2 years after completing the CAR-T cell treatment regime.
Rhoncus duis elementum suspendisse odio amet arcu tellus. Sapien felis vestibulum euismod eget orci scelerisque id. Non ut sagittis leo et. Et pretium nisl ultrices dapibus sit euismod volutpat elementum.
Symptom Onset: July 2017
Clinical Diagnosis: Refractory relapsed Hodgkin lymphoma, CD30 positive.
Treatment: Autologous anti-CD30 CAR-T cell therapy.
Clinical Efficacy: The patient was in remission 2.5 months after infusion initiation, with PET-CT scans showing complete dissipation in 2018. The patient had no adverse reactions to treatment, such as cytokine storm or neurotoxicity. The patient has returned to normal and has a high quality of life.
Explore the basics of CAR-T therapies, from foundations to manufacturing.
Learn more about our CAR-T CDMO manufacturing for high-quality therapies.
Discover the current manufacturing approaches for LVV and its deployment in cell therapies.
The production timeline for CAR-T and CAR-NK therapies can vary based on specific project requirements. Generally, the process, including cell collection, genetic modification, cell expansion, and quality control, takes approximately 2 weeks. Additional time may be needed for regulatory approvals and logistical considerations.
CAR-T and CAR-NK cell therapies both involve genetically modifying immune cells to fight cancer, but they use different cell types and mechanisms. CAR-T therapy uses T cells, which are part of the adaptive immune system. Autologous CAR-T therapies collect T cells from the patient, genetically modified to express chimeric antigen receptors (CARs), expanded, and reinfused into the patient to target and kill cancer cells. In contrast, CAR-NK therapy uses natural killer (NK) cells from the innate immune system, which have inherent cytotoxic abilities. The CAR modification enhances their specificity and efficacy against cancer cells.
Both CAR-T and CAR-NK cells can be either autologous or allogeneic (from a healthy donor), allowing for the possibility of "off-the-shelf" therapies that can be administered to multiple patients without the need for personalized cell collection and modification. For allogeneic cell therapies, CRISPR gene editing is usually performed. uBriGene offers off-the-shelf GMP-grade CAS proteins and mRNA. We also provide in vitro transcribed sgRNA production service, which is cost-effective and more potent in gene editing than chemically synthesized.
Yes, CAR-T cells are genetically modified. The process involves collecting T cells from a patient's blood (autologous) or healthy donors (allogeneic) and then altering them in the laboratory to express chimeric antigen receptors (CARs) on their surface. These receptors are designed to recognize and bind to specific proteins on the surface of cancer cells. The genetically modified CAR-T cells are then expanded in number and infused back into the patient to target and kill cancer cells effectively.
uBriGene operates GMP-compliant facilities in North America and China, ensuring adherence to international standards, including those set by the U.S. FDA, European EMA, Health Canada, and Australian TGA, and China NMPA. Our global presence with facilities in the US and APAC allows us to provide seamless regulatory compliance and efficient process transfers across regions.
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.
Sit aliquam elit vitae bibendum lectus blandit dictum. Nisi porta elementum sed diam eleifend pellentesque. Quis aenean quam.
Request a Quote
Optional caption section: This caption text can be used under any image or content block as-needed. Use cases are figure legends, citations, image descriptions
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.
