Concepedia

Lot Release Testing

Lot Release Testing is a regulatory quality control process, as a singular academic concept, that belongs to the genus of biopharmaceutical validation methods and is differentially defined by its requirement for mandatory pre-market assessment of specific batches of biologic products to verify compliance with established safety, purity, potency, and identity criteria under current Good Manufacturing Practices.

31

Publications

1.4K

Citations

263

Authors

85

Institutions

Publications per year

2017–2026

7

Variants

Batch Release Testing

Parents

Publications

31

National Institutes of Health–Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities

Camillo Ricordi, Julia Goldstein, Appakalai N. Balamurugan et al. · Diabetes · 2016 · 197 citations · Full text

, , +17

Capillary Electrophoresis Sodium Dodecyl Sulfate Nongel Sieving Analysis of a Therapeutic Recombinant Monoclonal Antibody:  A Biotechnology Perspective

Glenn E. Hunt, Wassim Nashabeh · Analytical Chemistry · 1999 · 153 citations

, , +15

On-Line CE−LIF−MS Technology for the Direct Characterization of N-Linked Glycans from Therapeutic Antibodies

Lynn Gennaro, Oscar Salas‐Solano · Analytical Chemistry · 2008 · 131 citations

, , +16

Development and validation of an antibody-dependent cell-mediated cytotoxicity-reporter gene assay

Bhavin S. Parekh, E. Berger, Sharon Sibley et al. · mAbs · 2012 · 101 citations · Full text

, , +17

Mass Spectrometric-Based Stable Isotopic 2-Aminobenzoic Acid Glycan Mapping for Rapid Glycan Screening of Biotherapeutics

Justin M. Prien, Bradley D. Prater, Qiang Qin et al. · Analytical Chemistry · 2010 · 84 citations

, , +17

1–5 of 31

Authors

263

  1. RA
    Raja Atreya

    Friedrich-Alexander-Universität Erlangen-Nürnberg, Germany

    1 publications · 25 citations

    1

    h-index

  2. DB
    Daniel Brandhorst

    Justus-Liebig-Universität Gießen, Germany

    1 publications · 197 citations

    1

    h-index

  3. JS
    Janet Suker

    National Institute for Biological Standards and Control, United Kingdom

    1 publications · 42 citations

    1

    h-index

  4. YW
    Yunpeng Wang

    National Institutes for Food and Drug Control, China

    1 publications · 20 citations

    1

    h-index

  5. BS
    Bhavin S. Parekh

    Eli Lilly (United States), United States

    1 publications · 101 citations

    1

    h-index

1–5 of 263

Institutions

85

  1. Eli Lilly (United States)

    Indianapolis, United States

    3 h-index

    20 publications

    1.3K citations

  2. Amgen (United States)

    Thousand Oaks, United States

    3 h-index

    6 publications

    395 citations

  3. National Institute for Biological Standards and Control

    Potters Bar, United Kingdom

    3 h-index

    5 publications

    116 citations

  4. Institut de Recherche Vaccinale

    Créteil, France

    2 h-index

    6 publications

    99 citations

  5. Merck & Co., Inc., Rahway, NJ, USA (United States)

    Rahway, United States

    2 h-index

    3 publications

    61 citations

  6. National Institutes for Food and Drug Control

    Beijing, China

    2 h-index

    22 publications

    478 citations

  7. Indianapolis Zoo

    Indianapolis, United States

    2 h-index

    4 publications

    342 citations

  8. Genesys (United States)

    Daly City, United States

    2 h-index

    2 publications

    26 citations

1–8 of 85

Venues

  1. mAbs

    5 publications · 235 citations

    5

    h-index

  2. PubMed

    Repository · 4 publications · 98 citations

    4

    h-index

  3. Analytical Chemistry

    3 publications · 368 citations

    3

    h-index

  4. Procedia in Vaccinology

    2 publications · 40 citations

    2

    h-index

  5. BioProcessing Journal

    2 publications · 34 citations

    2

    h-index

1–5