Validating human induced pluripotent stem cell-specific quality control tests for the release of an intermediate drug product in a Good Manufacturing Practice quality system

Author:

Novoa JuanORCID,Westra Inge,Steeneveld EstherORCID,Neves Natascha FonsecaORCID,Daleman LizanneORCID,Asensio Albert Blanch,Davis Richard P.ORCID,Carlotti FrançoiseORCID,Freund Christian,Rabelink TonORCID,Meij PaulineORCID,Wieles BrigitteORCID

Funder

Leiden University Medical Center

Publisher

Elsevier BV

Reference35 articles.

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2. European Medicines Agency (1995). CPMP/ICH/381/95), ICH Topic Q2 (R1) Validation of Analytical Procedures: Text and Methodology,https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-2-r1-validation-analytical-procedures-text-and-methodology-step-5_en.pdf [accessed 22.04.2024].

3. Autologous bone marrow-derived mesenchymal stromal cell therapy with early tacrolimus withdrawal: The randomized prospective, single-center, open-label TRITON study;Reinders;Am J Transplant,2021

4. Phase I/II study protocol to assess safety and efficacy of adoptive cell therapy with anti-PD-1 plus low-dose pegylated-interferon-alpha in patients with metastatic melanoma refractory to standard of care treatments: the ACTME trial;van der Kooij;BMJ Open,2020

5. HA-1H T-Cell Receptor Gene Transfer to Redirect Virus-Specific T Cells for Treatment of Hematological Malignancies After Allogeneic Stem Cell Transplantation: A Phase 1 Clinical Study;van Balen;Front Immunol,2020

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