Papers matching “good manufacturing practices” 60
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Good Manufacturing Practice–compliant human induced pluripotent stem cells: from bench to putative clinical products2024 Cytotherapy article Biochemistry, Genetics and Molecular Biology Pluripotent Stem Cells Research Open access cited by 1 patent
Juan José Novoa, Inge M. Westra, Esther Steeneveld, Natascha Fonseca Neves, Christiaan H. Arendzen, Bahareh Rajaei, +15 more
42citations -
Validating human induced pluripotent stem cell-specific quality control tests for the release of an intermediate drug product in a Good Manufacturing Practice quality system2024 Cytotherapy article Biochemistry, Genetics and Molecular Biology Pluripotent Stem Cells Research Open access cited by 1 patent
Juan José Novoa, Inge M. Westra, Esther Steeneveld, Natascha Fonseca Neves, Lizanne Daleman, Albert Blanch-Asensio, +6 more
9citations -
Monitoring the manufacturing and quality of medicines: a fundamental task of pharmacovigilance2021 Therapeutic Advances in Drug Safety article Pharmacology, Toxicology and Pharmaceutics Pharmacovigilance and Adverse Drug Reactions Open access
Glyn Belcher, Calin Lungu, Terenzio Ignoni, Manuela Camisa, Doris I. Stenver, Paolo Porcelli, +16 more
66citations -
From Single Batch to Mass Production–Automated Platform Design Concept for a Phase II Clinical Trial Tissue Engineered Cartilage Product2021 Frontiers in Medicine article Medicine Tissue Engineering and Regenerative Medicine Open access cited by 1 patent
Sebastian Haeusner, Laura Herbst, Patrick Bittorf, Chris Henze, Marc Mauermann, Jelena Ochs, +6 more
16citations -
Automated manufacture of ΔNPM1 TCR-engineered T cells for AML therapy2024 Molecular Therapy — Methods & Clinical Development article Medicine CAR-T cell therapy research Open access
Isabella Elias Yonezawa Ogusuku, Vera Herbel, Simon Lennartz, Caroline Brandes, Eva M. Argiro, C. Fabian, +12 more
8citations -
Anthroposophic Medicinal Products: A Literature Review of Features, Similarities and Differences to Conventional Medicinal Products, Scientific and Regulatory Assessment2022 Global Advances in Health and Medicine article Medicine Complementary and Alternative Medicine Studies Open access
Erik Wim Baars, Gunver Sophia Kienle, Peter Heusser, Peter Alsted Pedersen, Herman van Wietmarschen, Helmut Kiene, +2 more
6citations -
Manufacture of Clostridioides difficile spores for experimental infection of human volunteers2025 bioRxiv (Cold Spring Harbor Laboratory) preprint Medicine Clostridium difficile and Clostridium perfringens research Open access
Annefleur D. O. Hensen, Céline Harmanus, Christine Voorvelt, Anoecim Robecca Geelen, Maryam El Hamdioui, Ed J. Kuijper, +6 more
0citations -
ValRun: GMP-grade Manufacturing and Quality Control of a Non-Virally engineered Advanced Therapy Medicinal Product for Personalized Treatment of Age-Related Macular Degeneration2022 Zenodo (CERN European Organization for Nuclear Research) dataset Biochemistry, Genetics and Molecular Biology Retinal Development and Disorders Open access
Martina Kropp, Nina Harmening, Thais Bascuas, Sandra Johnen, Eline Elodie Barbara De Clerck, Mattia Ronchetti, +7 more
0citations -
ValRun: GMP-grade Manufacturing and Quality Control of a Non-Virally engineered Advanced Therapy Medicinal Product for Personalized Treatment of Age-Related Macular Degeneration2022 Zenodo (CERN European Organization for Nuclear Research) dataset Biochemistry, Genetics and Molecular Biology Retinal Development and Disorders Open access
Martina Kropp, Nina Harmening, Thais Bascuas, Sandra Johnen, Eline Elodie Barbara De Clerck, Mattia Ronchetti, +7 more
0citations -
GMP-Grade Manufacturing and Quality Control of a Non-Virally Engineered Advanced Therapy Medicinal Product for Personalized Treatment of Age-Related Macular Degeneration2022 Biomedicines article Biochemistry, Genetics and Molecular Biology Retinal Development and Disorders Open access
Martina Kropp, Nina Harmening, Thais Bascuas, Sandra Johnen, Eline Elodie Barbara De Clerck, Mattia Ronchetti, +7 more
13citations -
Advances in vaccine development through the controlled human infection models for hookworm and schistosomiasis2026 PLoS neglected tropical diseases article Immunology and Microbiology Parasites and Host Interactions Open access
Marie-Astrid Hoogerwerf, Moses Egesa, Selidgji Todagbe Agnandji, Alex C. Loukas, Meta Roestenberg
0citations -
Solution Oligonucleotide APIs: Regulatory Considerations2022 Therapeutic Innovation & Regulatory Science article Immunology and Microbiology Biosimilars and Bioanalytical Methods Open access
Christian Wetter, Chris Chorley, Corrine Curtis, Nicole del Canto, J. Gair Ford, Jennifer L. Franklin, +6 more
10citations