GMP Routine Batch Release & End-to-End Testing

CellMade provides fast, high-reliability quality control testing engineered to support commercial parenteral batch release and real-time bioprocess monitoring under full cGMP compliance. Built for seamless integration into industrial supply chains, our testing workflows combine rapid turnaround times with strict quality standards to safeguard every lot before release. From screening early in-process intermediates to conducting diagnostic root-cause investigations on failed production runs, we deliver the human-relevant data needed to ensure absolute batch-to-batch safety, regulatory compliance, and operational continuity.

• GMP QC Batch Release Testing: Fast-turnaround, cGMP-compliant pyrogen testing for commercial parenterals, complex biologics, vaccines, and medical devices, providing audit-ready release documentation.

• In-Process Quality Control (IPQC): Micro-volume testing of upstream and downstream bioprocess intermediates to detect raw material impurities or microbial contamination early in production.

• Out-of-Specification (OOS) & Root-Cause Investigations: Diagnostic MAT panels engineered to isolate, identify, and confirm specific non-endotoxin pyrogen (NEP) sources in OOS or compromised production lots.

• Parallel Testing (MAT vs. RPT/LAL): Head-to-head dual-method evaluation studies that build robust, comparative safety datasets to support smooth method transitions and regulatory filings.