Peripheral Blood Mononuclear Cells

Since 2007, CellMade™ has been a foundational expert in the development of primary human cell models. Our Peripheral Blood Mononuclear Cells (PBMCs) are not simply "cells in a vial"—they are functionally qualified assay reagents designed to ensure that pharmaceutical Quality Control (QC) and drug safety testing meet the most stringent global regulatory standards, including Ph. Eur. 2.6.30.

Strategic Market Formats

We provide cell configurations that align with industry workflows while offering unique flexibility that competitors often lack.

The CellMade™ Premium: Why We Lead the Market

Working with CellMade™ provides a distinct advantage over standard primary cell suppliers. While others provide generic PBMCs, we provide assay-ready functionality tailored to your specific regulatory needs.

1. Versatile Donor Configurations

We offer three distinct donor formats to address the full spectrum of immunological testing:

• Single Donor: Critical for Personalized Medicine and identifying donor-specific sensitivities. Single-donor vials are the preferred choice for investigating individual variability in cytokine release or when mapping specific HLA-restricted responses in drug development.
• 4-Donor Pooled: A robust entry point for standardized screening that meets the minimum requirements for the Monocyte Activation Test (MAT).
• Premium 8-Donor Pooled (The CellMade™ Standard):  Reduced Variability: Minimizes the impact of individual "low-responders" or "hyper-responders."
  • Superior Representation: Provides a broader spectrum of HLA types, mirroring the "average human" immune response more accurately than 4-donor pools.
  • Regulatory Future-Proofing: Meets the Ph. Eur. recommendation for using 8 or more donors where practicable to ensure the highest assay sensitivity and minimize false negatives.

2. Pre-Qualified Functional Characterization

Every lot of CellMade™ PBMCs undergoes rigorous functional testing before release:

• MAT-Qualified: Confirmed responsiveness to both Endotoxin (LPS) and Non-Endotoxin Pyrogens (NEPs) like LTA, HKSA, and R848.
• Cytokine Benchmarking: Pre-screened for reliable secretion of IL-6, IL-1β, and TNF-α, ensuring high signal-to-noise ratios in safety assays.
• Post-Thaw Excellence: We guarantee >90% viability, ensuring that the metabolic activity of the monocytes is preserved for immediate cytokine production.

Safety, Ethics, and Quality

Bio-Ethical Sourcing & Compliance

• Informed Consent: All cells are derived from healthy volunteers who have provided full, written informed consent for commercial research use.
• Full Traceability: Sourced under strict IRB/Ethics Committee approved protocols with comprehensive documentation available for audits.
• Ethical Pedigree: 100% compliant with international bio-ethical guidelines, ensuring your data is acceptable to global regulatory bodies (EMA, FDA, PDMA).

Standard Safety Testing

To ensure laboratory safety and experimental purity, all lots are certified negative for:

• Pathogens: HIV-1/2, Hepatitis B (HBV), and Hepatitis C (HCV).
• Sterility: Verified free of Mycoplasma, bacteria, and fungi.
• Immunophenotyping: Full CD-marker breakdown (CD3+, CD14+, CD19+, CD56+) included in every Certificate of Analysis (CoA).

Experience Matters: Since 2007

With nearly two decades of experience, CellMade™ understands the nuances of primary cell biology that newer entrants miss. Our long-standing history means you are partnering with a team that has navigated the evolution of the Monocyte Activation Test from its inception to its current status as the mandatory replacement for animal-based pyrogen testing.

The CellMade™ Advantage

When you choose CellMade™ Functionally Characterized Human PBMCs, you gain more than cells in a vial; you gain a comprehensive analytical partnership.

• Expert Technical Support: Every solution is backed by direct access to validation reports, detailed kit inserts, and expert consultation to help you optimize your specific workflow.

Procurement & Implementation

Access to CellMade™ Pharmaceutical Quality Control products is restricted to ensure peak performance and regulatory alignment. These products are available exclusively under a purchase license following a mandatory technical onboarding process:

• Feasibility & Method Development: Initial assessment and protocol design tailored to your specific application.

• Validation & Transfer: Product-specific validation followed by a formal method transfer to your facility.

• Implementation: Comprehensive on-site training to ensure seamless integration into your QC workflow.