Regulatory Transition & In-House Technology Transfer

CellMade provides end-to-end technical guidance and operational support to help biopharmaceutical organizations seamlessly phase out legacy animal assays in favor of human-relevant Monocyte Activation Testing (MAT). Beyond contract laboratory services, we empower partners to establish, validate, and run MAT capabilities within their own facilities. By combining strategic assay replacement roadmaps, on-site analyst enablement, and global regulatory dossier compilation, we ensure a smooth, risk-free transition that aligns your quality control infrastructure with evolving international pharmacopeial standards.

• Legacy Assay Replacement Roadmap: Tailored gap analyses and strategic execution plans to systematically phase out Rabbit Pyrogen Testing (RPT) and Limulus Amebocyte Lysate (LAL) assays in favor of validated MAT platforms.

• EMA, FDA, and EFSA Dossier Support: Complete technical dossier authoring, validation report compilation, and regulatory liaison support to smooth marketing authorization applications and global regulatory filings.

• In-House Technology Transfer & Onsite Enablement: Turnkey protocol transfer, hands-on analyst training, equipment qualification support, and facility setup for biopharma laboratories bringing MAT internal.

• Regulatory Trend Audits & Audit Readiness: Comprehensive pre-audit reviews and regulatory benchmarking to ensure internal MAT workflows fully comply with updated European (Ph. Eur.), US (USP), and Japanese (JP) pharmacopeial mandates.