Robust GMP iPSC and MSC manufacturing platforms offering access to qualified raw materials, including reprogramming mix and CRISPR gene editing.
Our GMP iPSC/MSC manufacturing CDMO platforms bring extensive expertise in GMP-compliant cell therapy product development. Our CDMO services include advanced stem cell production techniques, rigorous quality testing, and comprehensive IND application support.
Access to our efficient iPSC reprogramming mRNA-LNP mix and CRISPR gene editing tools greatly facilitates iPSC generation.
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Extensive iPSC/MSC manufacturing experience with access to essential raw materials, including iPSC reprogramming mRNA-LNP mix and CRISPR gene editing tools.
These advantages not only improve the efficiency and reliability of the manufacturing process but also ensure a more cost-effective production of cells.
Consult with us for seamless IND submissions, regulatory compliance, and cutting-edge technology in CAR-NK and CAR-T CDMO manufacturing services.
GMP grade iPSC reprogramming mRNA-LNP cocktail
CRISPR Cas9 proteins and mRNA
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We offer customizable stem cell production services tailored to specific research or therapeutic needs. This includes donor cell selection, iPSC reprogramming optimization or mesenchymal stem cell isolation, cell banking, and process and analytical method development based on project requirements.
Our quality control testing includes rigorous testing for cell identity, purity, potency, and safety. Additionally, our regulatory affairs team can support IND filing.
Scope of work Diagram for iPSC and MSC manufacturing
Request a quoteStreamline your process with our one-stop services, including donor cell sourcing, iPSC generation using uBriGene’s innovative reprogramming mRNA-LNP cocktail, and iPSC gene modification via CRISPR gene editing with our GMP-grade Cas9 proteins or RNP. After iPSC monoclonal screening, we assist with iPSC master cell banking and differentiation into specialized cell types.
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’s innovative iPSC reprogramming mRNA-LNP cocktail is easy to use and can be directly added to somatic fibroblast or PBMC cells, with no virus or transfection required. The iPSC generation efficiency with this reprogramming mRNA-LNP mix is around 1-5%, depending on cell sources, significantly higher than other available iPSC reprogramming reagents.
Our quality control testing includes rigorous testing for cell identity, purity, potency, and safety. Additionally, our regulatory affairs team can support IND filing.
Fig. 1. Timeline of somatic cell reprogramming using uBriGene’s mRNA-LNP cocktail
Request a quoteThe significance of our typical MSC (Mesenchymal Stem Cell) production process workflow lies in its integrated, one-stop comprehensive service, ensuring efficiency, consistency, and quality at every stage of GMP stem cell manufacturing. This includes tissue sample collection, stem cell separation and amplification, cell bank construction, MCB verification, large-scale stem cell production, harvest and aseptic filling, followed by quality inspection and product release.
MSC GMP manufacturing workflow diagram
Request a quoteAt uBriGene, we uphold the highest standards of quality control and assurance throughout our GMP iPSC/MSC manufacturing process, ensuring that every product meets stringent criteria for safety, purity, and efficacy.
| Testing Items | Assay |
|---|---|
| Sterility | Immersion Sterility tests(B/F) |
| Mycoplasma Testing | Culture and cell indication assay |
| Endotoxin | Kinetic chromogenic LAL |
| Cell Viability | Trypan Blue |
| Pluripotency Characteristics | Flow cytometry |
| Embryoid body formation | |
| Genetic stability | STR Genotyping |
| Karyotype Analysis | |
| Viral factor inspection | Transmission Electron Microcopy (TEM) |
| In vitro Assay for Adventitious Virus Contaminant | |
| Fluorescent Product Enhanced Reverse Transcriptase (FPERT) method |
*Outsourced testing
Stem cell production undergoes rigorous testing using advanced techniques to ensure regulatory compliance and exceed customer expectations. Testing is conducted at every stage, from raw material sourcing to final GMP iPSC release, including but not limited to the following tests:
Identity and Purity Testing: Ensuring the genetic integrity and purity of our iPSC lines.
Sterility Testing: Confirming the absence of microbial contaminants.
Viability and Proliferation Assays: Assessing the health and proliferative capacity of our iPSCs/MSCs.
Genetic Stability Assessment: Monitoring for genetic alterations during expansion and passaging.
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.
At uBriGene, we uphold the highest standards of quality control and assurance throughout our GMP iPSC/MSC manufacturing process, ensuring that every product meets stringent criteria for safety, purity, and efficacy.
We provide comprehensive GMP manufacturing services, including donor screening, iPSC generation, MSC production, cell banking, process development, quality control, and regulatory support. Our services also include analytical method development and GMP-grade production for clinical applications.
uBriGene uses an efficient mRNA-LNP reprogramming mix for iPSC generation, available in both research and GMP grades. We also offer GMP-grade Cas9 nuclease, Cas9 mRNA, and sgRNA production for gene editing, as well as single-stranded DNA and linear closed-end dsDNA manufacturing. Yes, we offer full CRISPR gene editing services.
Mesenchymal stem cells (MSCs) are stromal cells used in treatments like myocardial infarction, fibrosis, and inflammatory diseases. MSCs, derived from adult and neonatal tissues, are valued for tissue regeneration, immune modulation, and low immunogenicity.
Yes, we offer customizable production services, including donor cell selection, protocol optimization, and comprehensive cell banking (MCB, WCB) under GMP conditions.
We conduct rigorous testing for cell identity, purity, potency, and sterility, along with karyotyping and genetic stability checks. Our processes comply with FDA, EMA, NMPA, and other regulatory guidelines.
Turnaround times vary by project scale—iPSC production takes weeks to months, while MSC production takes several weeks. We also offer regulatory support for clinical trial submissions.
We have extensive experience in large-scale production, using bioreactors and automation technologies. Our QA processes include SOPs, batch record documentation, and regular audits to ensure reproducibility and consistency.
We provide comprehensive documentation, including batch records and certificates of analysis, for regulatory submissions.
We employ stringent quality control measures, including regular monitoring of cell cultures for genetic stability using karyotyping, SNP analysis, and other techniques to detect any abnormalities.
Yes, we offer iPSC differentiation services to generate specific cell types, such as cardiomyocytes, neurons, or hepatocytes, for research or drug discovery purposes.
We follow strict quality assurance processes, including SOPs (Standard Operating Procedures), batch record documentation, and regular audits, to ensure reproducibility and consistency in cell manufacturing.
Yes, we have extensive experience working with regulatory agencies to support cell therapy approvals and regulatory submissions, including the FDA, EMA, NMPA, and TGA.
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.
Extensive stem cell manufacturing expertise
Access to efficient iPSC reprogramming mRNA-LNP mix
Access to CRISPR gene editing tools and services
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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.
