
Smooth transition from small-scale R&D batches to large-scale GMP production.
Flexible production capacity for pilot, clinical, and commercial supply.
Unified SOPs and process controls ensure consistent quality across scales.
Dual Verification: Every gene synthesis and vector construct undergoes Sanger sequencing for base-level accuracy and NGS (Next-Generation Sequencing) for full-length confirmation.
In-Process QC: Each manufacturing stage follows validated SOPs with real-time monitoring.
Full Traceability: Batch records covering raw materials, synthesis parameters, and QC results.
Advanced Analytical Tools: HPLC/UPLC, LC-MS, spectrophotometry, and bioinformatics analysis.
Manufacturing facilities certified for ISO 9001, ISO 13485, and designed to meet GMP standards.
Processes aligned with FDA, EMA, and NMPA guidelines for nucleic acid drug manufacturing.
Comprehensive documentation packages available for regulatory submissions.
From primers to final GMP product.
No delays from multi-vendor hand-offs.
Dual verification and in-process monitoring.