This collaboration provides European biotech and biopharmaceutical companies with direct access to human Peripheral Blood Mononuclear Cell-based Monocyte Activation Testing (MAT) and comprehensive pyrogen safety solutions.
The partnership directly addresses critical safety and regulatory shifts in the pharmaceutical industry. Following the removal of the Rabbit Pyrogen Test (RPT) from the European Pharmacopoeia framework in January 2026, developers of complex biologics, vaccines, and advanced therapies need robust, animal-free pyrogen testing strategies tailored to the specific risk profile of each product. Recombinant Factor C (rFC) represents a well-established and highly specific approach for the detection of Gram-negative bacterial endotoxins. Where a broader assessment of pyrogenic risk is required, particularly when Low Endotoxin Recovery (LER) and Non-Endotoxin Pyrogens (NEPs) may be relevant, the human PBMC-based MAT provides an important alternative by reflecting the human innate immune response and enabling detection of a wider spectrum of pyrogens. Selection between rFC and MAT should therefore be driven by the product characteristics, matrix, and pyrogen risk assessment studies, with each method offering distinct strengths within a modern animal-free testing strategy.
A Risk-Based, Product-Specific Approach
Conscio Group and CellMade Laboratories move beyond a “one-size-fits-all” model. Because modern biological medicines feature complex raw materials and advanced formulations, the partners combine pyrogen risk assessment, rFC, MAT, and LER troubleshooting into a single integrated solution. The partners now support pharmaceutical developers through all stages of implementation:
- Feasibility Studies: Comprehensive screening via risk management
- Method Development: Custom testing protocols tailored to specific product matrices
- Product Validation: Product-specific validation to meet stringent regulatory criteria
- GMP Routine Test: Support for a seamless transition into routine quality control
- Regulatory Documentation: Full technical and regulatory-supporting paperwork.
This collaboration aligns with global regulatory evolutions, including the European Pharmacopoeia Chapter 5.1.13 and US FDA guidelines, which advocate for risk-based, human-relevant testing strategies. Together, Conscio Group and CellMade Laboratories ensure that the future of pharmaceutical quality control is scientifically rigorous, sustainable, and optimized for next-generation medicines.
About CellMade Laboratories
CellMade Laboratories is an independent French laboratory specializing in innovative, human-cell-based testing methodologies. The laboratory provides advanced pyrogen safety solutions designed to replace traditional animal testing with high-precision, human-relevant alternatives.
