Cell Therapy Analytical Development and Testing
Delivering consistent and reproducible CGTs quickly requires adapted analytical techniques and timely QC release. At OmniaBio, we combine phase-appropriate analytical methods, custom assay development, and QC testing under one roof to accelerate time-to-market without compromising quality.
Standard Assays
Successful Projects
Analytical and QC Capabilities
Technical Leadership
T Cell Platform Expertise
AI-Enabled Automation
Advancing CAR-T Affordability and Accessibility for Patients
Autologous cell therapies are currently costly due to labor-intensive processes, patient-specific batch production, and outsourced quality testing. Small batch sizes and stringent quality control requirements drive up the COGs, creating accessibility barriers for patients in need.
At OmniaBio, we are redefining CAR-T cell manufacturing to make transformative therapies more affordable and accessible. Through our focus on advanced automation, AI enablement, and on-site quality control across four critical areas, we can optimize your production efficiency and streamline batch release to reduce COGs and improve patient accessibility.| Advanced Donor Cell Screening | Leveraging machine learning, our system can help predict donor T-cell manufacturability and clinical efficacy, enabling higher chances of therapeutic success. |
| Automated Quality Control | By automating quality control processes, we reduce human involvement by 80% and achieve rapid release in just 3 days, streamlining time to patients without compromising safety. |
| Optimized Bioprocessing Footprint | With robotic “hotelling” of cell processing equipment, our vertical and horizontal setups enhance throughput, increasing output per square meter by 300% for maximized space and scale operations. |
| Intelligent Vein-to-Vein Logistics | From donor raw materials to final drug products, AI-driven routing, tracking, and rerouting systems ensure seamless delivery, reducing logistical bottlenecks and improving overall reliability. |
Advanced Donor Cell Screening
Automated Quality Control
Optimized Bioprocessing Footprint
Intelligent Vein-to-Vein Logistics
Comprehensive Cell and Gene Therapy Analytical Development
- Standard assays fully developed for identity, purity, potency, cell counts, and viability of immunotherapies
- Well-characterized assays for viral vectors to quantify infectious titre, physical titre, residual host cell protein, and DNA
- Full impurity testing panel
- High-throughput, automated platforms for development and screening
- Product-specific assay development
- Integrated assay development and quality control teams to support technology transfer of custom assays
Custom Analytical Assay Development
For maximum efficacy and safety, your analytical method should be as specific as your product. At OmniaBio, we customize analytical assays to align with your reagents, starting materials, in-process intermediates, and more to ensure precise measurements and enhanced quality.
Our capabilities include:
Flow cytometry-based assays:
- Phenotyping/identityーPBMCs, T, CAR-T, B, NK, CAR-NK cells/iPSCs/MSCs/HEKs/hepatocytes
- Potency/functional assaysー for proliferation, cytotoxicity, antigen presentation assays, differentiation, infectious titres – LVV, and intracellular cytokines
qPCR- & ddPCR-based assays:
- Identityーfor transgene expression, viral titres, vector copy number, and differentiation markers
ELISA:
- Potency/functional assaysーfor cytotoxicity and cytokine release
- Purity assaysーfor host cell protein (HCP) and host cell DNA (HCDNA) assessment
| Testing Available |
|---|
| STR testing |
| Culture morphology |
| Flow cytometry – cell-type specific markers |
| Sterility testing USP <71> |
| Mycoplasma USP <63> |
| Adventitious agents / virology testing |
| Endotoxin |
| Karyotype |
| Viability |
| Total cell number |
| Recovery |
| Edit confirmation sequencing* |
| Targeted NGS* |
| Flow cytometry for functional edit* |
| ddPCR or similar for edit* |
Established Quality Control and Stability Testing
Through our established quality control and stability testing panels, adaptable to meet your unique product needs, we can efficiently test and release your cell bank adhering to your program timelines.
Discover our rigorous quality control and in-house storage services to support the safety and efficacy of your stored cells.
Dedicated Analytical Development and CL2 Quality Control Labs
Seamless Cell Therapy GMP Manufacturing
Do you need a seamless path from cell banking to manufacturing?
OmniaBio offers a continuum of cell therapy CDMO services, leveraging purpose-built infrastructure, specialized capabilities, and years of experience to support the transition of your therapeutic program from preclinical to commercial stages.
FEATURED RESOURCE
Precise and Reliable Analytical Development
For Lentiviral Gene-Modified CAR-T Products Characterization
Read about how OmniaBio optimized infectious titre (IT) and vector copy number assays (VCN) using ddPCR and flow-based analytical methods. Discover this customizable panel of analytics and how it can support seamless transfer to GMP manufacturing and to the clinic.
In-House Quality Control
Our 6,500ft2 dedicated QC lab enables in-house testing for direct quality control oversight, ensuring timely in-process and release testing results, especially for rate-limiting safety tests, and the scheduling flexibility needed to adhere to your program requirements and timelines.
By offering internal QC testing, we can help you eliminate delays tied to third-party testing, reduce costs, and accelerate the production and delivery of your autologous cell therapy products. Let’s Talk About How We Can Help
Our in-house cell therapy analytical development and QC capabilities will support your program every step of the way.