Offers three-week, closed-system TIL manufacturing ensuring precision, scalability, and reliable GMP-grade cell therapy production
uBriGene Biosciences is a global cell and gene therapy CDMO with proven expertise in complex tumor-infiltrating lymphocyte (TIL) manufacturing processes that require extensive open manipulations.
Our proprietary automated platform delivers consistent, scalable, and potent TIL products within three weeks, advancing your immunotherapy development with confidence.
We provide rapid/comprehensive QC release testing, including viability, potency, purity, and safety.
Yield & Viability
TILs derived from both lung and melanoma tumor samples exhibited consistently high cell yield and viability throughout the manufacturing process.
Purity
Expanded TILs showed a consistently high proportion of CD4⁺ and CD8⁺ subsets, with minimal monocyte and NK cell contamination.
Potency
Potency and IFN-γ release assays confirmed strong TIL functionality, highlighting a robust, reproducible, and scalable expansion process suitable for clinical manufacturing.
As an experienced cell and gene therapy CDMO, uBriGene addresses key pain points in TIL manufacturing process simplification and automation.
We have successfully expanded TILs ex vivo to clinical doses, incorporating: G-Rex, Wave 25 Rocker Bioreactor, Sepax C-Pro Cell processing System, and Lovo cell processing system.
Figure 1. Schematic representation of the preREP and REP TIL manufacturing process
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Figure 2. Growth kinetics of TILs during expansion in the Xuri Cell Expansion System
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.
| Test Item | 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 microscopy (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.
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GMP TIL manufacturing typically begins with tumor tissue collection and preparation, followed by initial TIL outgrowth (pre-REP) and large-scale rapid expansion (REP). The expanded TILs are then harvested, processed, and evaluated through quality control and release testing for characteristics such as identity, purity, viability, potency, and safety. uBriGene supports TIL manufacturing using a simplified, closed and automated process designed to achieve clinical-scale TIL expansion within approximately three weeks.
uBriGene's TIL platform supports GMP TIL manufacturing in approximately three weeks, from TIL expansion through final product production, depending on the specific program and process requirements. uBriGene has completed more than 10 GMP TIL manufacturing runs using its closed and automated platform, supporting rapid and reproducible expansion for clinical development.
GMP TIL products require testing of critical quality attributes such as cell identity, purity, viability, potency, and safety. uBriGene's TIL manufacturing workflow includes comprehensive QC and release testing, with flow cytometry used to assess T-cell populations and potency testing including IFN-γ release assays to evaluate TIL functionality. The final testing strategy and acceptance criteria are established according to the specific product, manufacturing process, and clinical requirements.
A closed and automated TIL manufacturing system can reduce manual handling and open processing steps, helping minimize contamination risk and process variability while improving manufacturing consistency and scalability. uBriGene's TIL platform uses a simplified, closed and automated workflow designed to support reproducible TIL expansion and GMP production within approximately three weeks. uBriGene has applied the platform to more than 10 GMP TIL manufacturing runs.
Yes. uBriGene supports TIL programs across process development, technology transfer, process verification, GMP manufacturing, quality control, and regulatory support. Its TIL platform has been used for GMP TIL manufacturing at uBriGene's Maryland facility, including technology transfer and process verification for the GT307 TIL program that received FDA IND clearance in 2026.
Key challenges in TIL manufacturing include variability in starting tumor material, achieving sufficient TIL outgrowth and expansion, maintaining product quality during large-scale culture, minimizing contamination risk, and completing manufacturing within a clinically practical timeline. Open and labor-intensive processes can also increase manufacturing complexity and variability. Closed, automated workflows are being developed to reduce manual handling, improve process consistency, and support scalable GMP TIL production.
uBriGene has used G-Rex, Wave 25 Rocker Bioreactor, Sepax C-Pro Cell Processing System, and Lovo Cell Processing System for ex vivo TIL expansion and processing. These systems support different stages of TIL manufacturing, including cell expansion and cell processing, within a workflow designed for clinical-scale GMP production.
Simplified & Automated TIL Manufacturing processes
Integrated End-to-End Services
Experienced TIL Experts
Global Cell and Gene CDMO Footprint
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.
