REQUEST A QUOTE
REQUEST A QUOTE
Home » Services » CMC Support » mAb and Protein Testing

mAb and Protein Drug 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.
Home » Services » CMC Support » mAb and Protein Testing

mAb and Protein Drug 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>

Have Questions?

We are dedicated to timely, high-quality service from the start of your project to the finish. Send us a quick message with your questions to find out what Avance can do for you.

CONTACT US