Services

Quality, Supply Chain & Logistics

Ensuring Operational Quality

Raw material sourcing and quality documentation are often treated as coordination tasks, left to the client to manage, along with the cost and risk that come with them. NueCell Bio identifies suitable vendors and raw materials and applies our quality system, with SOPs, change control, and documentation built in from day one.

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Quality Management System

  • SOP Authoring & Document Lifecycle Management

    Procedure development, periodic review, version control, and training record management for all program-relevant SOPs.

  • Deviation & CAPA Management

    Structured deviation investigation, root cause analysis, and CAPA implementation with documented closure and effectiveness checks.

  • Change Control

    Formal change control for process, material, equipment, and method changes, with regulatory impact assessment included.

  • Supplier Qualification & Auditing

    Vendor qualification programs for critical raw material suppliers, with ongoing monitoring and approved vendor list management.

  • PD & AD Technical Reports

    Structured technical reports for process and analytical development activities, formatted for IND submission readiness.

  • Operator Training and Equipment Management

    All operators have structured and documented training curricula, all equipment is calibrated and maintenance managed through our CMMS

Raw Materials: Accountability
with GMP Usage in Mind

  • Raw material sourcing & vendor identification

  • Vendor/supplier qualification programs

  • Analysis of critical raw material risk assessment & mitigation

  • Single-use consumable inventory & management

  • Leukapheresis & donor starting material coordination

  • Incoming material receipt, inspection & quarantine

  • Shipping and cold chain logistics

Controlled Operational Practices

  • Temporal and spatial segregation
  • Pre- and post-work area decontamination
  • Line clearance between cell types and patient cells
  • Quarantine and analysis of incoming biological materials
  • Routine analytical surveillance for contamination control
  • Tracking and trending of analytical test performance, standards, and controls
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

Engineering Capabilities

  • Gene editing
  • Viral delivery
  • Non-viral delivery
  • Cellular reprogramming

Explore Our Other Capabilities

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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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