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

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

doi:10.1038/s41598-025-92736-9

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

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. OjalaMatti Korhonen, Heidi Hongisto, Anita Laitinen

Research output: Contribution to journal › Article › Scientific › peer-review

Original language	English
Article number	8093
Journal	Scientific Reports
Volume	15
Issue number	1
Number of pages	17
ISSN	2045-2322
DOIs	https://doi.org/10.1038/s41598-025-92736-9
Publication status	Published - 8 Mar 2025
MoE publication type	A1 Journal article-refereed

Bibliographical note

Publisher Copyright:
© The Author(s) 2025.

Fields of Science

Analytical testing
ATMP
CAR T-cell
Early development
Manufacturing
3111 Biomedicine

Access to Document

10.1038/s41598-025-92736-9

s41598-025-92736-9 (1)Final published version, 6.66 MBLicence: CC BY-NC-ND

Cite this

Luostarinen, A., Vuorela, A., Kerkelä, E., Patrikoski, M., Kotovuori, A., Koski, J., Ahoniemi, J., Lähteenmäki, K., Lehtisalo, J., Oja, T., Paavilainen, H., Autio, A., Nyman, M., Nikoskelainen, V., Kergourlay, V., Elbasani, E., van Veen, B., Thotakura, A., Monzo, H., ... Laitinen, A. (2025). Establishing a GMP-compliant manufacturing process and phase-appropriate analytics for early development of a FiCAR T-cell product with a novel CAR spacer. Scientific Reports, 15(1), Article 8093. https://doi.org/10.1038/s41598-025-92736-9

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

keywords = "Analytical testing, ATMP, CAR T-cell, Early development, Manufacturing, 3111 Biomedicine",

author = "Annu Luostarinen and Arja Vuorela and Erja Kerkel{\"a} and Mimmi Patrikoski and Annika Kotovuori and Jan Koski and Jonna Ahoniemi and Kaarina L{\"a}hteenm{\"a}ki and Jenni Lehtisalo and Terhi Oja and Henrik Paavilainen and Anu Autio and Marie Nyman and Veera Nikoskelainen and Virginie Kergourlay and Endrit Elbasani and {van Veen}, Bert and Anil Thotakura and Hector Monzo and Ojala, {P{\"a}ivi M.} and Matti Korhonen and Heidi Hongisto and Anita Laitinen",

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Luostarinen, A, Vuorela, A, Kerkelä, E, Patrikoski, M, Kotovuori, A, Koski, J, Ahoniemi, J, Lähteenmäki, K, Lehtisalo, J, Oja, T, Paavilainen, H, Autio, A, Nyman, M, Nikoskelainen, V, Kergourlay, V, Elbasani, E, van Veen, B, Thotakura, A, Monzo, H, Ojala, PM, Korhonen, M, Hongisto, H & Laitinen, A 2025, 'Establishing a GMP-compliant manufacturing process and phase-appropriate analytics for early development of a FiCAR T-cell product with a novel CAR spacer', Scientific Reports, vol. 15, no. 1, 8093. https://doi.org/10.1038/s41598-025-92736-9

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AU - Luostarinen, Annu

AU - Vuorela, Arja

AU - Kerkelä, Erja

AU - Patrikoski, Mimmi

AU - Kotovuori, Annika

AU - Koski, Jan

AU - Ahoniemi, Jonna

AU - Lähteenmäki, Kaarina

AU - Lehtisalo, Jenni

AU - Oja, Terhi

AU - Paavilainen, Henrik

AU - Autio, Anu

AU - Nyman, Marie

AU - Nikoskelainen, Veera

AU - Kergourlay, Virginie

AU - Elbasani, Endrit

AU - van Veen, Bert

AU - Thotakura, Anil

AU - Monzo, Hector

AU - Ojala, Päivi M.

AU - Korhonen, Matti

AU - Hongisto, Heidi

AU - Laitinen, Anita

PY - 2025/3/8

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KW - ATMP

KW - CAR T-cell

KW - Early development

KW - Manufacturing

KW - 3111 Biomedicine

U2 - 10.1038/s41598-025-92736-9

DO - 10.1038/s41598-025-92736-9

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