Establishing a GMP-compliant manufacturing process and phase-appropriate analytics for early development of a FiCAR T-cell product with a novel CAR spacer

Authors: Annu Luostarinen, Arja Vuorela, Erja Kerkelä, Mimmi Patrikoski, Annika Kotovuori, Jan Koski, Jonna Ahoniemi, Kaarina Lähteenmäki, Jenni Lehtisalo, Terhi Oja, Henrik Paavilainen, Anu Autio, Marie Nyman, Veera Nikoskelainen, Virginie Kergourlay, Endrit Elbasani, Bert van Veen, Anil Thotakura, Hector Monzo, Päivi M. Ojala, Matti Korhonen, Heidi Hongisto, Anita Laitinen

Source: Scientific Reports, Vol 15, Iss 1, Pp 1-17 (2025)

Subject Terms: CAR T-cell, ATMP, Early development, Manufacturing, Analytical testing, Medicine, Science

File Description: electronic resource

Relation: https://doaj.org/toc/2045-2322

Access URL: https://doaj.org/article/37172f3531a74b4c84a7bffb378f546c

Cell-based medicinal products: a review of current research

Authors: E. V. Galitsyna, E. A. Kulikova, Yu. A. Pavelyev, O. S. Kuznetsova, A. S. Senina, A. B. Gusev

Source: Биопрепараты: Профилактика, диагностика, лечение, Vol 24, Iss 4, Pp 428-442 (2024)

Subject Terms: cell therapy, cell-based medicinal products, tissue-engineered products, gene therapy, advanced therapy medicinal products, atmp, mesenchymal stem cells, limbal stem cells, haematopoietic stem cells, car-t cell therapy, car-nk cell therapy, clinical trials, Biotechnology, TP248.13-248.65, Medicine

File Description: electronic resource

Relation: https://www.biopreparations.ru/jour/article/view/557; https://doaj.org/toc/2221-996X; https://doaj.org/toc/2619-1156

Access URL: https://doaj.org/article/71b16dd86533411c952e6f3a29aa44af

Classification of Cell Therapy Products by Cell Manipulation Degree and Functions Performed: Analysis of International Regulatory Approaches

Authors: M. A. Vodyakova, N. S. Pokrovsky, I. S. Semenova, V. A. Merkulov, E. V. Melnikova

Source: Регуляторные исследования и экспертиза лекарственных средств, Vol 14, Iss 5, Pp 533-546 (2024)

Subject Terms: stromal vascular fraction, fat tissue, advanced therapy medicinal product, atmp, legal regulation, quality control, degree of cell manipulation, cell product, minimal manipulation, homologous use, non-homologous use, Medicine (General), R5-920

File Description: electronic resource

Relation: https://www.vedomostincesmp.ru/jour/article/view/710; https://doaj.org/toc/3034-3062; https://doaj.org/toc/3034-3453

Access URL: https://doaj.org/article/96ac40fe76d347d489ab3c66b8f579db

Towards propagation of epidermal cells for wound repair: glass, as cell culture substrate, enhances proliferation and migration of human keratinocytes

Authors: Hady Shahin, Ingrid Steinvall, Folke Sjöberg, Moustafa Elmasry, Ahmed El-Serafi

Source: Frontiers in Bioengineering and Biotechnology, Vol 13 (2025)

Subject Terms: keratinocytes, culture substrate, glass, epidermal differentiation, migration, ATMP, Biotechnology, TP248.13-248.65

File Description: electronic resource

Relation: https://www.frontiersin.org/articles/10.3389/fbioe.2025.1547044/full; https://doaj.org/toc/2296-4185

Access URL: https://doaj.org/article/f077368c5af940368c795820c44173b9

Towards implementing new payment models for the reimbursement of high-cost, curative therapies in Europe: insights from semi-structured interviews

Authors: Thomas Desmet, Sissel Michelsen, Elena Van den Brande, Walter Van Dyck, Steven Simoens, Isabelle Huys

Source: Frontiers in Pharmacology, Vol 15 (2025)

Subject Terms: semi-structured interviews, managed entry agreements (MEA), annuity, spread payment, outcome-based reimbursement, advanced therapy medicinal product (ATMP), Therapeutics. Pharmacology, RM1-950

File Description: electronic resource

Relation: https://www.frontiersin.org/articles/10.3389/fphar.2024.1397531/full; https://doaj.org/toc/1663-9812

Access URL: https://doaj.org/article/d98006e4cf164dd08abc31aebc68fc4c

1st Central European Conference for Advanced Therapy and Immunotherapy. Book of Abstracts

Contributors: Salačová, Markéta, Pospíšilová, Lucie, Vladíková, Hana

Subject Terms: CREATIC, ATMP, rare diseases, innovative therapies, Diseases and disorders

File Description: image/jpeg

Access URL: https://directory.doabooks.org/handle/20.500.12854/148527
https://munispace.muni.cz/library/catalog/download/2392/7500/5319-1

Particulates in CGT guidance survey results – an ISCT process development & manufacturing committee perspective on cell and gene therapy industry knowledge awareness

Authors: Durand, Nisha ¹, Davies, Lindsay ^{2, 3, 4}, Davies, Stephanie ⁵, McGowan, Domhnall ⁶, Clarke, Dominic ⁷, Oh, Steve ⁸, Sethi, Dalip ⁹, Werner, Sean ¹⁰, Molina, Samuel A. ^{11, ⁎}

Source: In Cytotherapy March 2025 27(3):287-294

Xenotransplantation of mitochondria: A novel strategy to alleviate ischemia-reperfusion injury during ex vivo lung perfusion

Authors: Bechet, Nicholas B. ^{a, b, c}, Celik, Aybuke ^{a, b, c, d, e}, Mittendorfer, Margareta ^{a, b, c}, Wang, Qi ^{a, b, c}, Huzevka, Tibor ^{a, b, c, f}, Kjellberg, Gunilla ^g, Boden, Embla ^{a, b, c}, Hirdman, Gabriel ^{a, b, c}, Pierre, Leif ^{a, b, c, h}, Niroomand, Anna ^{a, b, c}, Olm, Franziska ^{a, b, c, h}, McCully, James D. ^{d, e}, Lindstedt, Sandra ^{a, b, c, h, ⁎}

Source: In Journal of Heart and Lung Transplantation March 2025 44(3):448-459

Pluripotent stem-cell-derived therapies in clinical trial: A 2025 update

Authors: Kirkeby, Agnete ^{1, 2, ∗}, Main, Heather ³, Carpenter, Melissa ^{4, ∗∗}

Source: In Cell Stem Cell 2 January 2025 32(1):10-37

Using irAOP for non-clinical safety evaluation of biotechnology-derived pharmaceuticals and ATMPs: a paradigm shift into a systematic and holistic framework

Authors: Armin Braun, Susann Dehmel

Source: Journal of Immunotoxicology, Vol 21, Iss sup1, Pp S96-S98 (2024)

Subject Terms: Adverse outcome pathway, irAOP, imSAVAR, inflammation, ATMP, Immunologic diseases. Allergy, RC581-607, Toxicology. Poisons, RA1190-1270

File Description: electronic resource

Relation: https://doaj.org/toc/1547-691X; https://doaj.org/toc/1547-6901

Access URL: https://doaj.org/article/fb2bfa6d61f443f3b5d2d595519cdfde

Successful transport across continents of GMP-manufactured and cryopreserved culture-expanded human fetal liver-derived mesenchymal stem cells for use in a clinical trial

Authors: Ashis Kumar, Sowmya Ramesh, Lilian Walther-Jallow, Annika Goos, Vignesh Kumar, Åsa Ekblad, Vrisha Madhuri, Cecilia Götherström

Source: Regenerative Therapy, Vol 26, Iss , Pp 324-333 (2024)

Subject Terms: BOOST2B, Allogeneic stem cell therapy, Advanced therapy medicinal product, ATMP, Clinical trial, Bone differentiation, Medicine (General), R5-920, Cytology, QH573-671

File Description: electronic resource

Relation: http://www.sciencedirect.com/science/article/pii/S2352320424001196; https://doaj.org/toc/2352-3204

Access URL: https://doaj.org/article/bfe0c0c6d9564680869fca5ec55230a6

The issue of heterogeneity of MSC-based advanced therapy medicinal products–a review

Authors: Ana Bajc Česnik, Urban Švajger

Source: Frontiers in Cell and Developmental Biology, Vol 12 (2024)

Subject Terms: mesenchymal stromal (stem) cell, heterogeneity, pooling, equipotency, advanced therapy medicinal product (ATMP), cell therapy, Biology (General), QH301-705.5

File Description: electronic resource

Relation: https://www.frontiersin.org/articles/10.3389/fcell.2024.1400347/full; https://doaj.org/toc/2296-634X

Access URL: https://doaj.org/article/ba8c33af16f14dbbb1f359752d4db87b

Assessing biologic/toxicologic effects of extractables from plastic contact materials for advanced therapy manufacturing using cell painting assay and cytotoxicity screening

Authors: Ina Pahl, Axel Pahl, Armin Hauk, Dana Budde, Sonja Sievers, Lothar Fruth, Roberto Menzel

Source: Scientific Reports, Vol 14, Iss 1, Pp 1-12 (2024)

Subject Terms: Cell painting assay (CPA), Cell and gene therapy, Advanced therapy medicinal products (ATMP), Extractables and leachables, Single-use systems, Process equipment-related leachables (PERL), Medicine, Science

File Description: electronic resource

Relation: https://doaj.org/toc/2045-2322

Access URL: https://doaj.org/article/a9e48b2bcc5e4cc58888ef316ed17922

Qualification of a flow cytometry-based method for the evaluation of in vitro cytotoxicity of GTA002 natural killer cell therapy

Authors: Raimo, Monica ^{∗, 1}, Zavoianu, Alexandra G. ¹, Meijs, Wilma, Scholten, Pascal, Spanholtz, Jan

Source: In Heliyon 30 January 2024 10(2)

Advanced Therapies for Human Immunodeficiency Virus

Authors: Daniel Josef Lindegger

Source: Medical Sciences, Vol 12, Iss 3, p 33 (2024)

Subject Terms: advanced therapy medicinal products (ATMP), cell therapy, gene therapy, human immunodeficiency virus (HIV), trials, vaccines, Medicine

File Description: electronic resource

Relation: https://www.mdpi.com/2076-3271/12/3/33; https://doaj.org/toc/2076-3271

Access URL: https://doaj.org/article/6b74fc5a4ea84799b042ade72f92a17f

Bioengineered tissue and cell therapy products are efficiently cryopreserved with pathogen-inactivated human platelet lysate-based solutions

Authors: María Martín-López, Cristina Rosell-Valle, Blanca Arribas-Arribas, Beatriz Fernández-Muñoz, Rosario Jiménez, Sonia Nogueras, Ana Belén García-Delgado, Fernando Campos, Mónica Santos-González

Source: Stem Cell Research & Therapy, Vol 14, Iss 1, Pp 1-17 (2023)

Subject Terms: Artificial tissue, Cryopreservation solution, hPL, ATMP, Stem cell therapy, Freezing, Medicine (General), R5-920, Biochemistry, QD415-436

File Description: electronic resource

Relation: https://doaj.org/toc/1757-6512

Access URL: https://doaj.org/article/26f9ad8062ac4ed38a6c248ce972cc19

Nonclinical pharmacokinetics and biodistribution of VSV-GP using methods to decouple input drug disposition and viral replication

Authors: Richard Dambra, Andrea Matter, Kaitlynn Graca, Saeed Salehin Akhand, Saurin Mehta, Ashlee Bell-Cohn, Joyce M. Swenson, Sadia Abid, Dongyue Xin, Cedric Lewis, Luke Coyle, Min Wang, Kathleen Bunosso, Michelle Maugiri, Richard Ruiz, Corey M. Cirillo, Birgit Fogal, Christine Grimaldi, Adam Vigil, Charles Wood, Joseph Ashour

Source: Molecular Therapy: Methods & Clinical Development, Vol 28, Iss , Pp 190-207 (2023)

Subject Terms: pharmacokinetics, biodistribution, VSV-GP, virus, RNAscope, ATMP, Genetics, QH426-470, Cytology, QH573-671

File Description: electronic resource

Relation: http://www.sciencedirect.com/science/article/pii/S2329050122001863; https://doaj.org/toc/2329-0501

Access URL: https://doaj.org/article/3024fbf5d16a43ce88a4e4bd77f4e5ef

Basics of advanced therapy medicinal product development in academic pharma and the role of a GMP simulation unit

Authors: I. Johanna, A. Daudeij, F. Devina, C. Nijenhuis, B. Nuijen, B. Romberg, C. de Haar, J. Haanen, H. Dolstra, E. Bremer, Z. Sebestyen, T. Straetemans, I. Jedema, J. Kuball

Source: Immuno-Oncology and Technology, Vol 20, Iss , Pp 100411- (2023)

Subject Terms: cellular therapy, ATMP, GMP, process development, clinical translation, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282

File Description: electronic resource

Relation: http://www.sciencedirect.com/science/article/pii/S2590018823000400; https://doaj.org/toc/2590-0188

Access URL: https://doaj.org/article/c119a48014564075ab76aaf707787cb2

Accelerating development of engineered T cell therapies in the EU: current regulatory framework for studying multiple product versions and T2EVOLVE recommendations

Authors: Delphine Ammar, Inga Schapitz, Maik Luu, Michael Hudecek, Miriam Meyer, Timmothy Taps, Bernd Schröder, Zoltán Ivics, Carmen Sanges, Paul Franz, Ulrike Koehl, Helene Negre, Inez Johanna, Jacquelyn Awigena-Cook

Source: Frontiers in Immunology, Vol 14 (2023)

Subject Terms: advanced therapy medicinal products (ATMP), engineered T cell therapies, clinical development, multiple product candidates, parent-child approach, Immunologic diseases. Allergy, RC581-607

File Description: electronic resource

Relation: https://www.frontiersin.org/articles/10.3389/fimmu.2023.1280826/full; https://doaj.org/toc/1664-3224

Access URL: https://doaj.org/article/5d384e6985d7461ba55323e181207b7d

Personalized tissue-engineered arteries as vascular graft transplants: A safety study in sheep

Authors: Lachmi Jenndahl, Klas Österberg, Yalda Bogestål, Robin Simsa, Tobias Gustafsson-Hedberg, Patrik Stenlund, Sarunas Petronis, Annika Krona, Per Fogelstrand, Raimund Strehl, Joakim Håkansson

Source: Regenerative Therapy, Vol 21, Iss , Pp 331-341 (2022)

Subject Terms: ATMP, Blood vessels, Recellularization, Regenerative medicine, Scaffold, Tissue engineering, Medicine (General), R5-920, Cytology, QH573-671

File Description: electronic resource

Relation: http://www.sciencedirect.com/science/article/pii/S2352320422000827; https://doaj.org/toc/2352-3204

Access URL: https://doaj.org/article/fdf71105162b47e491573797f8f3420c