As critical upstream raw materials for biopharmaceutical R&D, protein products directly determine the accuracy and success of downstream drug development. Serving as the gatekeeper of protein quality, our quality control platform provides essential safeguards for the reliability and functionality of core reagents. Through systematic quality evaluation and control, we deliver scientific foundations for research decisions while ensuring the safety and efficacy of biopharmaceutical products.
ACROBiosystems has established an industry-leading protein quality control platform, implementing a full lifecycle quality control system for therapeutic proteins in compliance with the highest international standards. The platform holds multiple global certifications including ISO 9001:2015, ISO 13485:2016, GMP, and DMF filings, demonstrating full alignment with regulatory requirements.
ACROBiosystems Quality System Development Timeline
At the implementation level, we have established a rigorous quality control process that includes:
Testing over 15 critical parameters (concentration, purity, molecular weight, activity, stability, residuals, endotoxin levels)
Conducting 30+ tests per batch to ensure data reliability
Implementing a 4-stage review system (raw materials, in-process, release, documentation)
Enforcing 3-tier release controls (intermediate, semi-finished, and final products)
Strict Quality Control Procedures
This comprehensive QC system ensures consistent, high-quality protein production. Our quality control platform integrates a comprehensive suite of advanced analytical technologies including high-performance liquid chromatography (HPLC), size-exclusion chromatography with multi-angle light scattering (SEC-MALS), enzyme-linked immunosorbent assay (ELISA), surface plasmon resonance (SPR), bio-layer interferometry (BLI), fluorescence-activated cell sorting (FACS), and cell-based functional assays. This multi-dimensional analytical system enables complete characterization of protein structure, function, and stability. By employing this integrated technology platform, we ensure batch-to-batch consistency of high-quality protein reagents, with all testing performed under Good Laboratory Practice (GLP) standards accompanied by fully traceable raw data. Our quality control system provides end-to-end support for biopharmaceutical development, from early-stage screening through clinical application, while continuously driving innovation to elevate industry standards for protein reagent quality.