Analytical and Bioassay Quality Control

Analytical and bioassay quality control services provide integrated solutions with reliability and traceability, which especially emphasize a comprehensive quality management process to ensure the highest quality of data. The system includes quality control internal audit, electronic documentation and training systems, deviation and CAPA procedures and standard operating procedures. Creative Biolabs is certified by CLIA, GLP, and GCP, which furnishes a full-service GMP EU, USP and FDA compliant testing laboratory for analytical and bioassay services.

Analytical and Bioassay Tests

In accordance with the latest regulations and guidance from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), Creative Biolabs is capable of customizing the biological analysis and identification packaging to meet your unique biosimilar development needs. Advanced technologies and operating procedures are employed to ensure the critical data to be accurate, complied with standards and timely delivered, regardless of project size. Our diverse analytical methods can help you evaluate the comparability of therapeutic antibody and protein, which are mainly introduced from these two aspects: antibody release and antibody characterization.

Purity

✔ Visual appearance
✔ Concentration detection
✔ HP-SEC
✔ HP-IEX

Safety

✔ Sterility test
✔ Bacterial endotoxin test
✔ ELISA (sTNF affinity)
✔ Residual host protein, RNA and/or genomic DNA

Antibody release detection

Potency

✔ Binding analysis
✔ In vitro biological activity

Identify

✔ Peptide Mapping
✔ CEX-HPLC
✔ Immunodetection

Creative Biolabs has developed a novel technology to prepare fully human antibodies with enhanced stability and reduced propensity to aggregate. Please click CreStab™ technology for preventing antibody aggregation for more details.

The products for antibody characterization at Creative Biolabs not only involve the commercial aspects of therapeutic antibody pharmacokinetics but also relate to quality assurance in basic research. The following provides detailed technical resources for antibody characterization.

Amino acid composition
Amino acid sequence
Terminal amino acid sequence
Sulfhydryl groups and disulfide bridges
Carbohydrate structure
UV280 quantitative
Analytical excessive speed centrifugation

Our expertise in analytical and bioassay areas can help you find the optimal solution for your research. For more requirements, just contact us or send us a query directly.