Concepedia

Potency Assay Qualification

Potency Assay Qualification is a formal scientific process within bioanalytical method validation that establishes the suitability of a specific assay to accurately and reliably measure the biological activity of a therapeutic product in support of its quality, safety, and efficacy assessments.

10

Publications

279

Citations

51

Authors

17

Institutions

Publications per year

2017–2026

2

Parents

Publications

10

Potency determination of factor <scp>VIII</scp> and factor <scp>IX</scp> for new product labelling and postinfusion testing: challenges for caregivers and regulators

Johannes Dodt, A. R. Hubbard, S. J. Wicks et al. · Haemophilia · 2015 · 53 citations

, , +12

MTS dye based colorimetric CTLL-2 cell proliferation assay for product release and stability monitoring of Interleukin-15: Assay qualification, standardization and statistical analysis

Gopalan Soman, Xiaoyi Yang, Hengguang Jiang et al. · Journal of Immunological Methods · 2009 · 39 citations

, , +14

Development of an in vitro-based potency assay for anthrax vaccine

S F Little, W.M. Webster, Bruce E. Ivins et al. · Vaccine · 2004 · 37 citations

, , +14

An immuno-assay to quantify influenza virus hemagglutinin with correctly folded stalk domains in vaccine preparations

Madhusudan Rajendran, Weina Sun, Phillip Comella et al. · PLoS ONE · 2018 · 33 citations · Full text

, , +17

Reanalysis of the MERIT Study with the Enhanced Trofile Assay

Michael S. Saag · 46th Annual Meeting · 2008 · 30 citations

, , +11

1–5 of 10

Authors

51

  1. FS
    F. Sheffield

    National Institute for Biological Standards and Control, United Kingdom

    2 publications · 25 citations

    2

    h-index

  2. MV
    Marjorie V. Mussett

    National Institute for Biological Standards and Control, United Kingdom

    2 publications · 25 citations

    2

    h-index

  3. MG
    Marta Grau-Vorster

    Banc de Sang i Teixits, Spain

    1 publications · 28 citations

    1

    h-index

  4. PC
    Phillip Comella

    Icahn School of Medicine at Mount Sinai, United States

    1 publications · 33 citations

    1

    h-index

  5. CR
    Carmen Ramírez-Moncayo

    Universidad de Sevilla, Spain

    1 publications · 28 citations

    1

    h-index

1–5 of 51

Institutions

17

  1. National Institute for Biological Standards and Control

    Potters Bar, United Kingdom

    3 h-index

    5 publications

    142 citations

  2. United States Army Medical Research Institute of Infectious Diseases

    Frederick, United States

    1 h-index

    5 publications

    185 citations

  3. Data Management Services (United States)

    Frederick, United States

    1 h-index

    2 publications

    78 citations

  4. Icahn School of Medicine at Mount Sinai

    New York, United States

    1 h-index

    9 publications

    297 citations

  5. Frederick National Laboratory for Cancer Research

    Frederick, United States

    1 h-index

    2 publications

    78 citations

  6. Paul Ehrlich Institut

    Langen, Germany

    1 h-index

    1 publications

    53 citations

  7. Universitat Autònoma de Barcelona

    Cerdanyola del Vallès, Spain

    1 h-index

    1 publications

    28 citations

  8. European Science Foundation

    Strasbourg, France

    1 h-index

    2 publications

    106 citations

1–8 of 17

Venues

  1. Journal of Biological Standardization

    3 publications · 42 citations

    3

    h-index

  2. Journal of Immunological Methods

    1 publications · 39 citations

    1

    h-index

  3. PLoS ONE

    1 publications · 33 citations

    1

    h-index

  4. 46th Annual Meeting

    1 publications · 30 citations

    1

    h-index

  5. Haemophilia

    1 publications · 53 citations

    1

    h-index

1–5