Creating Reliable and Robust Research Cell Banks
ISO 9001–documented research-grade cell banking with the characterization depth, traceability, and documentation that support regulatory filings and bridge cleanly into GMP manufacturing.
Where Rework Starts at the Bank
A research cell bank built and characterized without GMP transfer in mind can create rework and delay, just when a program is on the verge of entering the clinic. We build ISO 9001-documented, fully characterized cell banks from the start, with the traceability and documentation depth that support your regulatory filings and bridge cleanly into downstream GMP manufacturing.
NueCell Bio generates high-quality, fully characterized RCBs under our ISO 9001 QMS with comprehensive documentation packages suitable for regulatory filings and downstream GMP transfer.
Specialized banking for pluripotent stem cell lines and characterization — including karyotyping, pluripotency marker profiling, and differentiation capacity confirmation.
Selection and screening of commercially available RUO and/or GMP-equivalent lines to support additional gene edits and differentiation process protocols.
Reference standard cell banks and materials production for assay qualification — ensuring assay consistency and comparability across your development program(s).
- STR profiling — cell identity verification
- Karyotype analysis — genomic integrity confirmation
- Functionality testing — cell-type specific readouts
- Cell count & viability — pre- and post-freeze
- Recovery assessment — post-thaw viability & expansion
- Mycoplasma & sterility — baseline safety testing
- Phenotypic profiling — identity marker confirmation
- Cryogenic Storage — On-site LN2 vapor phase, 24/7 alarm monitoring, temperature excursion documentation, and chain-of-custody for every vial accessed
- Documentation Package — ISO 9001-compliant Certificate of Testing (CoT) and manufacturing summary, structured for GMP transfer readiness
OUR EXPERTISE
Wide-Ranging Modality Expertise
Cell Types
- Primary cells (T, NK, Myeloid, etc.)
- Stem & progenitor cells (HSC, PSC, MSC, etc.)
- Specialized cells (differentiated stem cells, primary therapeutic cells)
Product architecture
- Autologous
- Adherent
- Scale-up
- Allogeneic
- Suspension
- Scale-out
Engineering Capabilities
- Gene editing
- Viral delivery
- Non-viral delivery
- Cellular reprogramming
