Matrix effect in ligand-binding assay: the importance of evaluating emerging technologies

Author:

Crisino Rebecca M1,Luo Linlin2,Geist Brian3,Zoghbi Jad4,Spriggs Franklin5

Affiliation:

1. Janssen R&D, L.L.C., 200 Great Valley Parkway, Malvern, PA, USA.

2. Bristol Myers Squibb, Lawrenceville, NJ, USA

3. Janssen R&D, L.L.C., Spring House, PA, USA

4. Sanofi, Framingham, MA, USA

5. Pfizer, Andover, MA, USA

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

Reference25 articles.

1. MoraJ, Fraser S, Garofolo F. Emerging technology evaluation in the biotherapeutics bioanalytical space: a collaborative affair.AAPS Newsmagazine, 14–18 May (2013).

2. US Department of Health and Human Services, US FDA, Center for Drug Evaluation and Research.Guidance for Industry: Bioanalytical Method Validation, Draft Guidance.FDA, Rockville, MD, USA (2013).

3. LiJ, Cheadle N, Schantz A, Shankar G. A lateral flow immunochromatographic method for anti-drug antibody detection in human serum. Presented at:2013 American Association of Pharmaceutical Scientists National Biotechnology Conference.San Diego, CA, USA, 20–22 May 2013.

4. QuQ, Rathi A, Gorovits Bet al.Development of a clinical assay for measuring anti-drug antibodies against a monoclonal antibody drug: overcoming soluble target interference. Presented at:2013 American Association of Pharmaceutical Scientists National Biotechnology Conference.San Diego, CA, USA, 20–22 May 2013.

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