mAb and Protein Testing
Protein-based biotherapeutics such as monoclonal antibodies have revolutionized the treatment of various diseases and continue to be a key area of innovation in the pharmaceutical industry. Avance Biosciences team provides a comprehensive panel of assay solutions for protein-based biotherapeutics from early drug development through final drug product testing to ensure the highest standards of product quality, integrity, safety, purity and potency.
Protein-Based Biotherapeutics Testing
Critical Quality Attributes
Assay
Description
Purity
Residual host cell DNA Quantitation
Quantitation of residual host cell DNA in test sample by QPCR by extraction (PCR inhibition observed when tested by dilution)
Residual host cell RNA Quantitation
Quantitation of residual host cell RNA in test sample by QPCR by extraction (PCR inhibition observed when tested by dilution)
Content
Protein quantitation
ELISA, MSD and/or Western Blot Analysis using the JESS™ platform
Genetic Integrity
Vector Genome Integrity
Confirm the integrity of the vector genome using QPCR/ddPCR, Bioanalyzer or CE
Safety
Bioburden
USP <61>
Endotoxin
USP <85>
Safety
Bioburden
USP <61>
Sterility
USP <71>
Other
Appearance
USP <790>
pH
USP <791>