YEASEN Biologics Quality & Safety Control Solutions
As biopharmaceuticals rapidly advance from antibody drugs and cell & gene therapies to mRNA vaccines, and as China-US dual filing standards continue to rise, the industry demands higher sensitivity and stronger compliance in biosafety testing.Yeasen provides one-stop quality and safety control solutions covering antibody drugs, gene/cell therapy, mRNA vaccines, and recombinant protein products. Our core modules include:
- Product-related impurity control
Monitoring of replication-competent virus risk and quantification of viral vector copy number to ensure gene integration safety for CGT products.
- Process-related impurity control
Detection of residual host-cell nucleic acids and proteins, as well as residual production reagents, to safeguard final product purity.
- Biological risk control
Endotoxin detection and removal, plus rapid mycoplasma testing, to mitigate microbial contamination risks throughout manufacturing.
Yeasen has maintained ISO 13485 certification for consecutive years and actively contributed to the drafting of the now-effective standard Quality Control Specification for Immune Cell Therapy Products (T/CITS 354-2025). Our quality control products have supported multiple clients in successfully completing China-US dual IND filings, providing reliable assurance for biologics quality and safety from R&D through commercialization.
