Cell Banking+
Building on CCRM’s regenerative medicine legacy and powered by OmniaBio’s purpose‑built GMP manufacturing, we enable a fully integrated journey from cell line development through Phase I/II/III and commercial scale.
With proven GMP success across iPSC, primary, and immortalized cell lines, we work with clients to deliver derisked development pathways, operational confidence, and analytics‑supported GMP readiness at every stage, making us the ideal partner for cell banking.
- Access to in‑house experts for technical guidance and program planning
- Templated GMP documentation for seamless transition into later stage
- Support that’s tailored to the scientific and operational needs of your therapy
Operational Excellence
95+ batches
(50 adherent; 34 iPSC; 45 suspension )
94% batch success rate
100% sterility track record
Scale & Yield Achievements
70+ Litres per batch
suspension culture
40× CellStack‑10 per batch
~80 L adherent culture
13B+ cells/batch
1000+ vials/batch
Fill & Finish Capabilities
Automated
Cryovials: 500 vials/20min
Semi-Automated
Crimp AT vials: 180vials/hr
Bag fill & finish available
Standardization & Tech Transfer
Templated documentation for rapid onboarding
Single or multi-suite synchronized manufacturing options
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
More Than a Facility
An Ecosystem of CGT-Focused Capabilities
OmniaBio is the latest addition to a vibrant CGT ecosystem. Launched through the technical excellence and established infrastructure of CCRM, the focus of OmniaBio spans from preclinical, process and analytical development through to commercial manufacturing. With deep expertise in iPSC, lentiviral vector (LVV) and immune cell-based therapeutic scale-up, we are focused on the success of next-generation therapeutics from early clinical stage through to launch, all within one organization. Our consolidated offering saves you time and reduces the risk of transferring your products for launch and commercialization.
Experienced Leadership
Our leadership… Anytime, anywhere.
Hanrong Wu
Hong Chang
Demonstrated Expertise in Cell Banking
With over a decade of experience and 80+ successful batches, our experts excel in iPSC reprogramming and cell banking, adherent cell expansion (serum and serum-free), suspension expansion, and differentiation/expansion of 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), Dopaminergic neuron, iPSC-derived pancreatic beta cell
Collaboration-First Approach: Your Goals, Our Focus
At CCRM and OmniaBio, we are committed to working with our clients to fully understand their program specifics, timelines, and constraints so that we can ensure timely therapeutic delivery.
That is why our integrated development and MSAT teams not only create robust, scalable, customized process workflows at reduced costs but also help you select the right manufacturing platform upfront to mitigate delays and accelerate your cell therapy program.
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
Case Study: Translating Complex Cell Culture Processes into GMP-Ready Manufacturing
Cell banking programs often reach a critical CMC inflection point when early development processes must be translated into reproducible, GMP-ready manufacturing operations without compromising identity, potency, purity, safety, viability, or sterility expectations. Across multiple anonymized programs involving suspension leukocytes, adherent primary cell types, and induced pluripotent stem cells, CCRM and OmniaBio supported clients facing high single-batch yield requirements, limited at-scale process characterization, and constrained development timelines. By applying platform process knowledge, structured technology transfer, raw material risk assessment, in-process monitoring, and disciplined GMP execution, the teams established manufacturing approaches capable of supporting robust cell bank production across diverse cell types and culture formats.
Go Beyond The Bank
Capabilities extend beyond banking to support end‑to‑end development, including clonal line creation with automated single‑cell seeding, IND‑enabling gene editing, iPSC differentiation and scale‑up, toxicology material production, viral bank manufacturing, and rapid tech transfer into GMP. To further de‑risk and accelerate programs, GMP‑compliant off‑the‑shelf iPSC lines, a suspension HEK293 cell line, and an LV‑producer cell line are available.
