Services

We make your 
cell therapy manufacturable

NueCell Bio provides right-fit solutions across the development continuum, spanning program design, cell engineering, manufacturing process and analytics design, process feasibility, process and analytical development, analytical testing, cell banking, manufacturing preparation, and technology transfer to drive GMP manufacturing.

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How NueCell Impacts Innovation and Manufacturing Alike

Innovators

Discover Science

NueCell Bio

NueStack™

Iterates & Defines
the Process

GMP Manufacturer

Executes at Scale

What innovators gain

  • A defined starting point

  • Milestone-based cost clarity

  • Freedom to choose your manufacturer

  • Faster, lower-risk path to GMP

  • Development tailored to your molecule

What manufacturers gain

  • A defined, transfer-ready process

  • Less capacity lost to rework

  • Higher first-pass success

  • A partner, not a competitor

From Early Feasibility Through GMP Technology Transfer

NueCell provides the services and expertise to bridge the gap between discovery science and GMP manufacturing by designing, engineering, de-risking, and locking your cell therapy process for clean transfer. We integrate advanced technologies into cell therapy workflows to improve outcomes. For example, AI- and ML-based tools support decision-making, and we work to automate processes where possible to improve product quality and efficiency.

  • Modality-specific workflow, equipment, raw-material and fit-for-purpose analytical selection from day one
  • Gap assessments and QbD-driven workflow design; feasibility and scoping studies
  • Somatic cell reprogramming from blood-derived or fibroblast starting material
  • Sendai, episomal and mRNA methods; source- and donor-matched SOPs; xeno-free media
  • Rational, risk-based method selection for difficult donors (pediatric, aged, disease-state)
  • CRISPR/Cas9, Cas12a, ZFN, TALEN, base and prime editing evaluation
  • Pre-edit target screening: locus sequencing, functional gRNA screening, nuclease/donor optimization
  • Single-cell clonal isolation, clone lineage tracking, HDR condition optimization
  • ssODN, plasmid and AAV donor design
  • Defined xeno-free 2D/3D differentiation; adherent and suspension formats matched to target scale
  • Stage-marker checkpoints, lineage identity and purity panels
  • Scaffolds, biomaterials and 3D organoid models
  • Bench-to-clinical/commercial process design, unit-operation optimization, scale-up / scale-down modeling
  • cGMP-equivalent raw materials and scaled-down processes designed for transfer
  • Process lock for GMP transfer; automation and closed-system flow-path design
  • Qualifiable assays developed alongside the process to ICH Q2(R2) standards
  • Flow cytometry, immunocytochemistry, imaging, qPCR/ddPCR, amplicon and on/off-target NGS
  • STR identity, karyotype, copy number, zygosity, residual reprogramming factor and residual iPSC (LoD-defined)
  • Sterility, mycoplasma, endotoxin, vector clearance; functional potency (MEA, contractility, electrophysiology)
  • Vetted, audited external partners for specialty assays
  • Research cell bank (RCB) manufacture under controlled conditions and QMS oversight, with full characterization, traceability, and documentation.
  • Tech transfer package for further creation of Master Cell Banks under GMP
  • Raw material sourcing and performance evaluation, vendor qualification and GMP-grade material strategy
  • Cold chain, storage, staging and packaging; 1,000 sq ft freezer/refrigerator /gas farm
  • Draft batch records and documentation managed in an electronic QMS
  • Process and analytical method transfer packages, PFDs, SOPs, draft batch records, BOMs
  • Controls and standards, assay transfer, PD and AD reports, risk assessments
  • Demonstrated clean handoff to third-party GMP operations, sponsor retains free choice of CDMO
  • Strategic, technical, operational and regulatory guidance across the CMC arc
  • Hands-on training programs delivered from a dedicated 700 sq ft training center
  • MSAT services; instrument, equipment and raw-material beta testing and performance evaluation
  • Equipment testing & integration into cell therapy workflows
  • Suitability testing for specific workflows
  • ML/AI image-based model building to ease decision-making
  • Identification of key, repeatable steps amenable to automation

40+

programs facilitated by NueStacks™

95%

on-time delivery track record

NueStack™

Pre-Built Stacks.
Expertly Assembled.

Proven technology stacks that address a development program’s needs, expertly assembled and tailored by a team with decades of practical experience and knowledge.

Expertise

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

Tissue Engineering Capabilities

  • Gene editing (CRISPR, ZFN, TALEN)
  • Viral delivery
  • Non-viral delivery (LNP, Liposome, Electroporation)
  • Cellular reprogramming

CONTACT US

Let’s Bridge Your Science to GMP

Tell us about your program. Our team will respond within two business days with an actionable plan and clear next steps — no procurement gauntlet, no boilerplate.

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