Effects of blood processing and sample storage on the stability of biotherapeutics and anti-drug antibodies. (June 2015)

• Record Type: Journal Article
• Authors: Andisik, Matthew; DeStefano, Lisa; Stefan, Colin; Gathani, Meghna; Laurino, Kevin; Lai, Vicky CH; Rajadhyaksha, Manoj; Torri, Albert; Shao, Weiping
• Is Part Of: Bioanalysis. Volume 7:Number 11(2015)
• Page Start: 1325
• Page End: 1335
• Publication Date: 2015-06
• Subjects: Drugs -- Analysis -- Periodicals; 615.19005
• DOI: 10.4155/bio.15.66
• Languages: English
• ISSNs: 1757-6180

Abstract

Background: 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.Methods: 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.Conclusion: 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.