title: Recommendations for the evaluation of specimen stability for flow cytometric testing during drug development.
abstract: The objective of this manuscript is to present an approach for evaluating specimen stability for flow cytometric methods used during drug development. While this approach specifically addresses stability assessment for assays to be used in clinical trials with centralized testing facilities, the concepts can be applied to any stability assessment for flow cytometric methods. The proposed approach is implemented during assay development and optimization, and includes suggestions for designing a stability assessment plan, data evaluation and acceptance criteria. Given that no single solution will be applicable in all scenarios, this manuscript offers the reader a roadmap for stability assessment and is intended to guide the investigator during both the method development phase and in the experimental design of the validation plan.
authors: Flow Contract Site Laboratory, LLC, 13029 NE 126th PL, Unit A229, Kirkland, WA 98034, USA. Electronic address: lynette.brown@fcslaboratory.com.
authors: Lynette
authors: L
authors: Brown
authors: Amgen, Inc., 1 Amgen Center Drive, Mailstop 30E-3-C, Thousand Oaks, CA 91320, USA. Electronic address: cherieg@amgen.com.
authors: Cherie L
authors: CL
authors: Green
authors: LabCorp Clinical Trials, Laboratory Corporation of America® Holdings, 201 Summit View Dr., Suite 200, Brentwood, TN 37027, USA. Electronic address: jonesn2@labcorp.com.
authors: Nicholas
authors: N
authors: Jones
authors: Flow Contract Site Laboratory, LLC, 13029 NE 126th PL, Unit A229, Kirkland, WA 98034, USA. Electronic address: jennifer.stewart@fcslaboratory.com.
authors: Jennifer J
authors: JJ
authors: Stewart
authors: Pfizer, Eastern Point Rd., Groton, CT 06340, USA. Electronic address: Stephanie.Fraser@pfizer.com.
authors: Stephanie
authors: S
authors: Fraser
authors: 411 Walnut St., #7166, Green Cove Springs, FL 32043, USA. Electronic address: krh2385@gmail.com.
authors: Kathy
authors: K
authors: Howell
authors: Clinical Laboratory Sciences, DSAR, Sanofi, One The Mountain Road, Framingham, MA 01701, USA. Electronic address: Yuanxin.Xu@genzyme.com.
authors: Yuanxin
authors: Y
authors: Xu
authors: 16 Rolling Lane, Hamilton, NJ 08690, USA. Electronic address: 4cghill@gmail.com.
authors: Carla G
authors: CG
authors: Hill
authors: Celgene Cellular Therapeutics, 7 Powder Horn Drive, Warren, NJ 07059, USA. Electronic address: cwiwi@celgene.com.
authors: Christopher A
authors: CA
authors: Wiwi
authors: Medimmune, LLC, One MedImmune Way, Gaithersburg, MD 20878, USA. Electronic address: whitew@medimmune.com.
authors: Wendy I
authors: WI
authors: White
authors: Pfizer Worldwide Research and Development, 10724 Science Center Drive, San Diego, CA 92121, USA. Electronic address: Peter.OBrien2@pfizer.com.
authors: Peter J
authors: PJ
authors: O'Brien
authors: Covance Central Laboratory Services, 8211 SciCor Dr, Indianapolis, IN 46214, USA. Electronic address: virginia.litwin@covance.com.
authors: Virginia
authors: V
authors: Litwin
mesh_terms: D053000:Analytic Sample Preparation Methods; D001800:Blood Specimen Collection / Q000379:methods* / Q000592:standards*; D055808:Drug Discovery; D005434:Flow Cytometry; D006801:Humans
keywords: Anticoagulants; Biomarker; Cell stabilization; Clinical trials; Flow cytometry; Specimen stability