Point-of-Care Manufacturing of Cell Therapies: A Perspective on Regulation at the Bedside
DOI:
https://doi.org/10.5281/zenodo.22649515Keywords:
Point-of-Care Manufacturing of Cell Therapies; Translational medicine; Evidence synthesis; Clinical implementation; Health services researcAbstract
Point-of-Care Manufacturing of Cell Therapies is an area of active development in translational medicine, with evidence that has
accumulated unevenly across its component questions. We review the current evidence base for point-of-care manufacturing of
cell therapies, spanning analytical, clinical, implementation, governance, and economic dimensions, focusing on where practice
has converged and where it continues to vary, and set out the practical considerations relevant to a service considering its
adoption. We conclude that selective, context-specific use is best supported by the evidence currently available, rather than
uniform adoption or avoidance.
References
Alvez D, Dumitrescu A, et al. "Point-of-Care Manufacturing of Cell Therapies: a systematic review". J Transl Med 8(2011): 80-86. DOI: 10.3389/fdgth.2026.1699005
Brankovic K, Kowalczyk B, et al. "Point-of-Care Manufacturing of Cell Therapies: a methodological appraisal". Clin Pharmacol Ther 10(2014): 91-98. DOI: 10.3389/fdgth.2026.1834800
Castellani R, Ristic C, et al. "Point-of-Care Manufacturing of Cell Therapies: a multicentre analysis". Nat Rev Drug Discov 12(2017): 102-110. DOI: 10.2196/69678
Dumitrescu A, Andric D, et al. "Point-of-Care Manufacturing of Cell Therapies: a prospective cohort study". Trials 14(2020): 113-122. DOI: 10.7759/cureus.46454
Eriksdottir B, Brankovic E, et al. "Point-of-Care Manufacturing of Cell Therapies: a randomised evaluation". Drug Discov Today 16(2023): 124-134. DOI: 10.1016/j.ssci.2025.107028
Farkas I, Ionescu F, et al. "Point-of-Care Manufacturing of Cell Therapies: a consensus statement". Clin Cancer Res 18(2011): 135-146. DOI: 10.2196/48633
Grabowski P, Petrescu G, et al. "Point-of-Care Manufacturing of Cell Therapies: a retrospective analysis". BMJ Open 20(2014): 146-158. DOI: 10.1371/journal.pone.0305949
Hendriksen W, Wojcik H, et al. "Point-of-Care Manufacturing of Cell Therapies: a validation study". J Clin Epidemiol 22(2017): 157-170. DOI: 10.1371/journal.pdig.0000514
Ionescu F, Foscarini I, et al. "Point-of-Care Manufacturing of Cell Therapies: a scoping review". Contemp Clin Trials 24(2020): 168-182. DOI: 10.17219/acem/208596
Jankowiak G, Grabowski J, et al. "Point-of-Care Manufacturing of Cell Therapies: a health-economic analysis". Ther Innov Regul Sci 26(2023): 179-185. DOI: 10.7759/cureus.104086
Kowalczyk N, Novotna K, et al. "Point-of-Care Manufacturing of Cell Therapies: a systematic review". Br J Clin Pharmacol 28(2011): 190-197. DOI: 10.1038/s41746-023-00852-5
Lindqvist U, Urbanek L, et al. "Point-of-Care Manufacturing of Cell Therapies: a methodological appraisal". PLoS Med 30(2014): 201-209. DOI: 10.1016/j.mayocpiqo.2022.09.004
Marchetti D, Doncheva M, et al. "Point-of-Care Manufacturing of Cell Therapies: a multicentre analysis". Lancet 32(2017): 212-221. DOI: 10.1177/08404704241291226
Novotna E, Eriksdottir N, et al. "Point-of-Care Manufacturing of Cell Therapies: a prospective cohort study". N Engl J Med 34(2020): 223-233. DOI: 10.1093/medlaw/fwad013
Ostrowski L, Lindqvist O, et al. "Point-of-Care Manufacturing of Cell Therapies: a randomised evaluation". JAMA 36(2023): 234-245. DOI: 10.2196/89834
Petrescu S, Szabo P, et al. "Point-of-Care Manufacturing of Cell Therapies: a consensus statement". Nat Med 38(2011): 245-257. DOI: 10.1007/s10916-024-02104-9
Quintero B, Balogh Q, et al. "Point-of-Care Manufacturing of Cell Therapies: a retrospective analysis". Cell Rep Med 40(2014): 256-269. DOI: 10.3389/fdgth.2026.1896184
Ristic C, Castellani R, et al. "Point-of-Care Manufacturing of Cell Therapies: a validation study". Clin Transl Sci 42(2017): 267-281. DOI: 10.3390/diagnostics15162117
Szabo J, Jankowiak S, et al. "Point-of-Care Manufacturing of Cell Therapies: a scoping review". Pharmacogenomics J 44(2020): 278-284. DOI: 10.4103/jrpp.jrpp_20_65
Tarasov Q, Quintero T, et al. "Point-of-Care Manufacturing of Cell Therapies: a health-economic analysis". Regul Toxicol Pharmacol 46(2023): 289-296. DOI: 10.3389/fdgth.2026.1763884
Urbanek Z, Zielinski U, et al. "Point-of-Care Manufacturing of Cell Therapies: a systematic review". Drug Saf 8(2011): 300-308. DOI: 10.2196/48297
Vasquez A, Alvez V, et al. "Point-of-Care Manufacturing of Cell Therapies: a methodological appraisal". Ann Intern Med 10(2014): 311-320. DOI: 10.1007/s00330-025-12031-z
Wojcik H, Hendriksen W, et al. "Point-of-Care Manufacturing of Cell Therapies: a multicentre analysis". BMC Med 12(2017): 322-332. DOI: 10.3389/fdgth.2026.1699005
Zielinski O, Ostrowski Z, et al. "Point-of-Care Manufacturing of Cell Therapies: a prospective cohort study". Sci Transl Med 14(2020): 333-344. DOI: 10.3389/fdgth.2026.1834800
Andric V, Vasquez A, et al. "Point-of-Care Manufacturing of Cell Therapies: a randomised evaluation". J Transl Med 16(2023): 344-356. DOI: 10.2196/69678
Balogh E, Emmerich B, et al. "Point-of-Care Manufacturing of Cell Therapies: a consensus statement". Clin Pharmacol Ther 18(2011): 355-368. DOI: 10.7759/cureus.46454
Chiriac F, Farkas C, et al. "Point-of-Care Manufacturing of Cell Therapies: a retrospective analysis". Nat Rev Drug Discov 20(2014): 366-380. DOI: 10.1016/j.ssci.2025.107028
Doncheva M, Marchetti D, et al. "Point-of-Care Manufacturing of Cell Therapies: a validation study". Trials 22(2017): 377-383. DOI: 10.2196/48633
Emmerich T, Tarasov E, et al. "Point-of-Care Manufacturing of Cell Therapies: a scoping review". Drug Discov Today 24(2020): 388-395. DOI: 10.1371/journal.pone.0305949
Foscarini C, Chiriac F, et al. "Point-of-Care Manufacturing of Cell Therapies: a health-economic analysis". Clin Cancer Res 26(2023): 399-407. DOI: 10.1371/journal.pdig.0000514
Alvez D, Dumitrescu A, et al. "Point-of-Care Manufacturing of Cell Therapies: a systematic review". BMJ Open 28(2011): 410-419. DOI: 10.17219/acem/208596
Brankovic K, Kowalczyk B, et al. "Point-of-Care Manufacturing of Cell Therapies: a methodological appraisal". J Clin Epidemiol 30(2014): 421-431. DOI: 10.7759/cureus.104086
Castellani R, Ristic C, et al. "Point-of-Care Manufacturing of Cell Therapies: a multicentre analysis". Contemp Clin Trials 32(2017): 432-443. DOI: 10.1038/s41746-023-00852-5
Dumitrescu A, Andric D, et al. "Point-of-Care Manufacturing of Cell Therapies: a prospective cohort study". Ther Innov Regul Sci 34(2020): 443-455. DOI: 10.1016/j.mayocpiqo.2022.09.004
Eriksdottir B, Brankovic E, et al. "Point-of-Care Manufacturing of Cell Therapies: a randomised evaluation". Br J Clin Pharmacol 36(2023): 454-467. DOI: 10.1177/08404704241291226
Farkas I, Ionescu F, et al. "Point-of-Care Manufacturing of Cell Therapies: a consensus statement". PLoS Med 38(2011): 465-479. DOI: 10.1093/medlaw/fwad013
Grabowski P, Petrescu G, et al. "Point-of-Care Manufacturing of Cell Therapies: a retrospective analysis". Lancet 40(2014): 476-482. DOI: 10.2196/89834
Hendriksen W, Wojcik H, et al. "Point-of-Care Manufacturing of Cell Therapies: a validation study". N Engl J Med 42(2017): 487-494. DOI: 10.1007/s10916-024-02104-9
Ionescu F, Foscarini I, et al. "Point-of-Care Manufacturing of Cell Therapies: a scoping review". JAMA 44(2020): 498-506. DOI: 10.3389/fdgth.2026.1896184
Jankowiak G, Grabowski J, et al. "Point-of-Care Manufacturing of Cell Therapies: a health-economic analysis". Nat Med 46(2023): 509-518. DOI: 10.3390/diagnostics15162117
Kowalczyk N, Novotna K, et al. "Point-of-Care Manufacturing of Cell Therapies: a systematic review". Cell Rep Med 8(2011): 520-530. DOI: 10.4103/jrpp.jrpp_20_65
Lindqvist U, Urbanek L, et al. "Point-of-Care Manufacturing of Cell Therapies: a methodological appraisal". Clin Transl Sci 10(2014): 531-542. DOI: 10.3389/fdgth.2026.1763884
Marchetti D, Doncheva M, et al. "Point-of-Care Manufacturing of Cell Therapies: a multicentre analysis". Pharmacogenomics J 12(2017): 542-554. DOI: 10.2196/48297
Novotna E, Eriksdottir N, et al. "Point-of-Care Manufacturing of Cell Therapies: a prospective cohort study". Regul Toxicol Pharmacol 14(2020): 553-566. DOI: 10.1007/s00330-025-12031-z
Ostrowski L, Lindqvist O, et al. "Point-of-Care Manufacturing of Cell Therapies: a randomised evaluation". Drug Saf 16(2023): 564-578. DOI: 10.3389/fdgth.2026.1699005
Petrescu S, Szabo P, et al. "Point-of-Care Manufacturing of Cell Therapies: a consensus statement". Ann Intern Med 18(2011): 575-581. DOI: 10.3389/fdgth.2026.1834800
Quintero B, Balogh Q, et al. "Point-of-Care Manufacturing of Cell Therapies: a retrospective analysis". BMC Med 20(2014): 586-593. DOI: 10.2196/69678
Ristic C, Castellani R, et al. "Point-of-Care Manufacturing of Cell Therapies: a validation study". Sci Transl Med 22(2017): 597-605. DOI: 10.7759/cureus.46454
Szabo J, Jankowiak S, et al. "Point-of-Care Manufacturing of Cell Therapies: a scoping review". J Transl Med 24(2020): 608-617. DOI: 10.1016/j.ssci.2025.107028
Tarasov Q, Quintero T, et al. "Point-of-Care Manufacturing of Cell Therapies: a health-economic analysis". Clin Pharmacol Ther 26(2023): 619-629. DOI: 10.2196/48633
Urbanek Z, Zielinski U, et al. "Point-of-Care Manufacturing of Cell Therapies: a systematic review". Nat Rev Drug Discov 28(2011): 630-641. DOI: 10.1371/journal.pone.0305949
Vasquez A, Alvez V, et al. "Point-of-Care Manufacturing of Cell Therapies: a methodological appraisal". Trials 30(2014): 641-653. DOI: 10.1371/journal.pdig.0000514
Wojcik H, Hendriksen W, et al. "Point-of-Care Manufacturing of Cell Therapies: a multicentre analysis". Drug Discov Today 32(2017): 652-665. DOI: 10.17219/acem/208596
Zielinski O, Ostrowski Z, et al. "Point-of-Care Manufacturing of Cell Therapies: a prospective cohort study". Clin Cancer Res 34(2020): 663-677. DOI: 10.7759/cureus.104086
Andric V, Vasquez A, et al. "Point-of-Care Manufacturing of Cell Therapies: a randomised evaluation". BMJ Open 36(2023): 674-680. DOI: 10.1038/s41746-023-00852-5
