Bibliography
- Miller L , BermanM, SeeramMet al. An ultrasensitive immuno-qPCR assay for quantification of intact PEG-IFNβ in human serum. Presented at:The 2011 American Association of Pharmaceutical Scientists National Biotech Conference. San Francisco, CA, USA, 16–18 May 2011.
- Adler M , JonasA, BaarM, SpenglerM. Highly sensitive cytokine quantification using Imperacer®, an immuno-PCR based ligand-binding assay system. Presented at:The 2011 American Association of Pharmaceutical Scientists National Biotech Conference. San Francisco, CA, USA, 16–18 May 2011.
- Cha KH , ParkK, LeeJH, HwangSJ. Quantitative determination of sirolimus in dog blood using liquid chromatography-tandem mass. Presented at:The 2011 American Association of Pharmaceutical Scientists National Biotech Conference. San Francisco, CA, USA, 16–18 May 2011.
- Lee JW , LiH, OrtizRet al. Development of a general LC–MS/MS method to quantify therapeutic monoclonal antibodies in preclinical samples using a common reference standard and internal standard. Presented at:The 2011 American Association of Pharmaceutical Scientists National Biotech Conference. San Francisco, CA, USA, 16–18 May 2011.
- Fernandez Ocana M , SunL. Determination of a therapeutic–Fc fusion protein in serum by immuno-enrichment LC–MS/MS and its applications to pharmacokinetics in rats and monkeys. Presented at:The 2011 American Association of Pharmaceutical Scientists National Biotech Conference. San Francisco, CA, USA, 16–18 May 2011.
- Abberley L , SzapacsM, HottensteinC, CiteroneD. Quantification of a humanized monoclonal Ab on the Gyrolab platform. Presented at:The 2011 American Association of Pharmaceutical Scientists National Biotech Conference. San Francisco, CA, USA, 16–18 May 2011.
- Given AM , OliverK, RayC. Understanding the advantages and challenges of gyros technology through the development of multiple PK immunoassays. Presented at:The 2011 American Association of Pharmaceutical Scientists National Biotech Conference. San Francisco, CA, USA, 16–18 May 2011.
- Pan J , SmallT, QinDet al. Comparison of the NIDS® rapid assay with ELISA methods in immunogenicity testing of two biotherapeutics. Presented at:The 2011 American Association of Pharmaceutical Scientists National Biotech Conference. San Francisco, CA, USA, 16–18 May 2011.
- Singh SK . Impact of product-related factors on immunogenicity of biotherapeutics. J. Pharm. Sci. 100(2), 354–387 (2011).
- Liu Y , ReidlerH, PanJet al. Double antigen bridging immunogenicity ELISA for the detection of anti-PEG antibodies. Presented at:The 2011 American Association of Pharmaceutical Scientists National Biotech Conference. San Francisco, CA, USA, 16–18 May 2011.
- Wu B , GunnGIII, ShankarG. Competitive ligand-binding assays for the detection of neutralizing antibodies. In:Detection and Quantification of Antibodies to Biopharmaceuticals. Trovey MG (Ed.). John Wiley & Sons, USA 175–192 (2011).
- Hu J , GuptaS, SwansonS, ZhuangY. A new approach to detect neutralizing antibody in a serum sample-serum free bioassay. Presented at:The 2011 American Association of Pharmaceutical Scientists National Biotech Conference. San Francisco, CA, USA, 16–18 May 2011.
- Wu B , MangirM, MillerP, GunIII G, Goldberg K. Ready-to-use cryopreserved cells offer improved bioassay performance and efficiency when compared to continuously cultured fresh cells for the detection of neutralizing antibodies to protein therapeutics. Presented at:The 2011 American Association of Pharmaceutical Scientists National Biotech Conference. San Francisco, CA, USA, 16–18 May 2011.
- Liu R , TzogasZ, PillutlaR. Is acid treatment a universal approach to improve immunogenicity bridging assay performance? Presented at: The 2011 American Association of Pharmaceutical Scientists National Biotech Conference. San Francisco, CA, USA, 16–18 May 2011.
- Clements-Egan A , SmithN, MellonK, ShankarG. Acid dissociation steps in immunogenicity assays: the potential for interference by previously bound drug targets. Presented at:The 2011 American Association of Pharmaceutical Scientists National Biotech Conference. San Francisco, CA, USA, 16–18 May 2011.
- Thway T . Method cross validation: case studies. Presented at:The 2011 American Association of Pharmaceutical Scientists National Biotech Conference. San Francisco, CA, USA, 16–18 May 2011.
- Amaravadi L . Method cross validation: the principles and practices. Presented at:The 2011 American Association of Pharmaceutical Scientists National Biotech Conference. San Francisco, CA, USA, 16–18 May 2011.
- Kulagina N , ZhuM. Case study: comprehensive incurred sample reanalysis investigation for clinical sample analysis. Presented at:The 2011 American Association of Pharmaceutical Scientists National Biotech Conference. San Francisco, CA, USA, 16–18 May 2011.
- Nijem I , ElliotR, ThompsonJ, LiuP, BrignoliS. Investigating ISR failures. Presented at:The 2011 American Association of Pharmaceutical Scientists National Biotech Conference. San Francisco, CA, USA, 16–18 May 2011.
- Gutierrez J , BensonK, PatelH, NielsenK, WrightL. Development of dried blood spot (DBS) assay for PK analysis of antibody therapeutics. Presented at:The 2011 American Association of Pharmaceutical Scientists National Biotech Conference. San Francisco, CA, USA, 16–18 May 2011.
- Spears A , HammondM, OlechR, BrilandoL, KalenskyM, RockM. Effects of different vendors and lots of bovine serum albumin upon immunoassays to support immunogenicity and pharmacokinetics of protein biotherapeutics. Presented at:The 2011 American Association of Pharmaceutical Scientists National Biotech Conference. San Francisco, CA, USA, 16–18 May 2011.
- Gambaradella JM , LaudascherS, YaskaninDD, BeaverCJ. Method transfer of a luminescence LBA. Presented at:The 2011 American Association of Pharmaceutical Scientists National Biotech Conference. San Francisco, CA, USA, 16–18 May 2011.
- Gorovits B . Immunogenicity: prediction, detection, and effective assay development. Bionanalysis2(9), 1539–1545 (2010).
- Crisino R , DerentJ, EirikisE. Yang T-Y. Automation of an electrochemiluminescent immunoassay for the quantification of compound X (a humanized monoclonal antibody) in human serum using the Hamilton STARlet. Presented at:The 2011 American Association of Pharmaceutical Scientists National Biotech Conference. San Francisco, CA, USA, 16–18 May 2011.
- Guidance for Industry. Bioanalytical Method Validation US Department of Health and Human Services FDA (CDER) and (CVM) May 2001.