{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T10:35:09Z","timestamp":1790850909521,"version":"4.1.0"},"reference-count":38,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,7,8]],"date-time":"2026-07-08T00:00:00Z","timestamp":1783468800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Bioeng. Biotechnol."],"abstract":"<jats:p>Advanced Therapy Medicinal Products \u2014 cell therapies, gene therapies, and tissue-engineered products \u2014 are beginning to deliver on the promise of curative medicine: CAR-T therapies double survival in chemotherapy-refractory lymphomas, gene therapies reverse the natural history of spinal muscular atrophy and hemoglobinopathies, and Pluripotent Stem Cell (PSC)-derived islet transplantation renders type 1 diabetic patients insulin-independent. Yet the trajectory from proof-of-concept to equitable, scalable deployment is consistently impeded not only by unresolved biology but also by engineering, manufacturing, logistical, regulatory, and economic bottlenecks that the bioengineering community has not engaged with at the required scale. In this Perspective, grounded in clinical experience across hematological malignancies, monogenic diseases, and metabolic disorders, we identify five rate-limiting bottlenecks where bioengineering intervention is urgently needed and uniquely tractable: scalable and adaptive biomanufacturing; real-time in-process quality control; precise targeted delivery; biomaterial and scaffold engineering for cellular engraftment and immune protection; and data-driven patient stratification constrained by health equity. We argue that the evolving regulatory landscape in Europe \u2014 including the European Biotech Act framework and ICH Quality by Design principles \u2014 creates structural incentives for engineering-led solutions, and that economic sustainability requires bioengineering to drive down production costs and enable the off-the-shelf transition. We call on the bioengineering community to engage with ATMP translation not as technical support to clinical medicine, but as a constitutive partner shaping its pace, cost, and equity.<\/jats:p>","DOI":"10.3389\/fbioe.2026.1868007","type":"journal-article","created":{"date-parts":[[2026,7,8]],"date-time":"2026-07-08T05:59:09Z","timestamp":1783490349000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":2,"title":["Engineering the future of advanced therapy medicinal products: a bioengineering call to action"],"prefix":"10.3389","volume":"14","author":[{"given":"Giulia","family":"Nieri","sequence":"first","affiliation":[{"name":"Biomedical Engineering Association (BEA), Politecnico di Milano","place":["Milan, Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Spiller","sequence":"additional","affiliation":[{"name":"Biomedical Engineering Association (BEA), Politecnico di Milano","place":["Milan, Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Federico","family":"Stella","sequence":"additional","affiliation":[{"name":"Hematology Division, Fondazione IRCCS Istituto Nazionale dei Tumori","place":["Milan, Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandro","family":"Aiuti","sequence":"additional","affiliation":[{"name":"San Raffaele Telethon Institute for Gene Therapy (SR-TIGET), IRCCS San Raffaele Scientific Institute","place":["Milan, Italy"]},{"name":"Universit\u00e0 Vita-Salute San Raffaele","place":["Milan, Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lorenzo","family":"Piemonti","sequence":"additional","affiliation":[{"name":"Universit\u00e0 Vita-Salute San Raffaele","place":["Milan, Italy"]},{"name":"Diabetes Research Institute (DRI), IRCCS San Raffaele Scientific Institute","place":["Milan, Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2026,7,8]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"839","DOI":"10.1016\/s0140-6736(20)31366-0","article-title":"Lisocabtagene maraleucel for patients with relapsed or refractory large B-Cell lymphomas (transcend nhl 001): a multicentre seamless design study","volume":"396","author":"Abramson","year":"2020","journal-title":"Lancet"},{"key":"B2","doi-asserted-by":"publisher","first-page":"1257","DOI":"10.1038\/s41591-026-04244-6","article-title":"In vivo generation of anti-bcma Car-T cells in relapsed or refractory multiple myeloma: a phase 1 study","volume":"32","author":"An","year":"2026","journal-title":"Nat. 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