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Effects of blood processing and sample storage on the stability of biotherapeutics and anti-drug antibodies.

Bioanalysis (2015-06-26)
Matthew Andisik, Lisa DeStefano, Colin Stefan, Meghna Gathani, Kevin Laurino, Vicky Ch Lai, Manoj Rajadhyaksha, Albert Torri, Weiping Shao
ABSTRACT

Pre-analytical factors such as sample processing, handling or storage could affect the stability of biotherapeutics and anti-drug antibodies in clinical samples, potentially impacting the pharmacokinetic and immunogenicity assessments. We used sarilumab, a fully human IgG1 monoclonal antibody, and evaluated the stability of sarilumab (both functional and bound forms) and anti-sarilumab antibodies in blood samples during serum collection and the impact of various processing conditions on the analyte stability in serum for long-term storage. We also assessed the incurred sample stability of these analytes in samples from clinical studies. Assessment of analyte stability can provide relevant information about sample stability under different pre-analytical conditions and improve the confidence in the validity of bioanalytical data generated.

MATERIALS
Product Number
Brand
Product Description

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