East-Mab Biomedical has passed ISO9001 certification，and the ISO 13485 certification is in progress by SGS. Passing the quality management certification system certification means:
Comply with laws and regulations; Repeatable production processes; Completeness and traceability of materials, production and inspection records; Controllable process from research and development, production to inspection; Effective control of nonconformities and changes; Regular inspections by ISO certification bodies; Continuous improvement.
For high-purity proteins, we use SDS-PAGE and SEC-HPLC method to detect the purity and homogeneity of products.
And we use Elisa method to detect the bioactivity test.
