Standardized Cell Banking Services
Mitigate development and manufacturing hurdles in your cell and gene therapy program with an efficient and reliable cell banking strategy. With over 80 successful cell banks generated, OmniaBio’s fully integrated cell banking services (RCB, MCB, and WCB) offer your team timely sourcing of critical materials, reliable yields, and streamlined documentation for simplified release.
Redefining CAR-T Cell Therapy Manufacturing
Of Experience in Stem Cell Banking
Cell Bank Batches Manufactured, Adherent & Suspension Types
GMP Cell Bank Batches Across Various Cell Types
On Average For Client-Specific Cell Bank Manufacturing & Release
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
Demonstrated Expertise in Cell Banking
With over a decade of experience and 80+ successful batches, our experts excel in stem cell banking, adherent cell expansion (serum and serum-free), suspension expansion, and diverse cell types, including, but not limited to:
- GMP: iPSC, K562, T cells, dendritic cells (DC), MSC, PBMC, HSC, Cord blood mononuclear cells (CBMNC), fibroblasts
- PD: In addition to the above, NK cells, iPSC-derived cardiomyocytes, iPSC-derived smoothen muscle cells, fibroblasts, iPSC-derived neuro progenitor cells (iNPC), iPSC-derived beta cell
Proactive Strategies to Streamline Your Path
Our process development team can conduct feasibility runs and media optimization before creating your master cell bank (MCB) to ensure optimal yields and minimize risks.
In addition, we maintain critical materials on hand to mitigate sourcing issues so that you can initiate your cell banking project on day 0 and keep your program on track.
Standardized Services to Simplify Your Program
Experience OmniaBio’s standardized cell banking services, designed to support your cell therapy program from early-stage development to commercial manufacturing. We offer:
- Standardized GMP cell banking for accelerated tech transfer and manufacturing.
- Established analytics testing panel for efficient testing and timely release.
- Templated documentation for seamless release and guaranteed compliance.*
*Including master batch records, bills of materials, bills of equipment, and unit operation SOPs—to advance your cell and gene therapy program seamlessly.
| Testing Panel |
|---|
| 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 comprehensive analytical development services to ensure the quality of your stored cells.
Purpose-Built, Technology-Driven Facilities
With state-of-the-art facilities and expertise, OmniaBio delivers comprehensive cell banking solutions to ensure quality, scalability, and compliance.
- Immunotherapy, iPSC, and Stem Cell manufacturing platforms
- 26 cleanrooms (Grades B and C)
- Dedicated spaces for process and analytical development
- Advanced automation and AI capabilities
- Compliant with US FDA, Health Canada, and European GMP standards
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.
PRESS RELEASE
Accelerating Somite Therapeutics’ DMD Program
Your Partner for iPSC Excellence
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.