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The number of approved CGT products continues to rise each year; however, many challenges remain, including donor\u2010to\u2010donor biological variability, contamination risks in aseptic processing, vector production issues, concerns about genomic safety, and cold\u2010chain instability. These problems negatively impact reproducibility, regulatory compliance, product quality, and patient access. The current literature in this area often focuses on individual aspects of the process without providing an integrated view of the entire CGT product life cycle within the framework of good manufacturing practice (GMP). This review covers the manufacturing issues in the CGT life cycle, ranging from development to commercial manufacturing, and places them in a changing global regulatory landscape. 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Looking forward, AI\u2010powered digital twins, continuous process verification, modular \u201cGMP\u2010in\u2010a\u2010box,\u201d allogeneic universal platforms, predictive cold chains, and sustainable green GMP are explored as routes to robust, scalable, and patient\u2010centered CGT manufacturing.<\/jats:p>","DOI":"10.1002\/bit.70361","type":"journal-article","created":{"date-parts":[[2026,8,31]],"date-time":"2026-08-31T05:44:02Z","timestamp":1788155042000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Cell and Gene Therapies Manufacturing Challenges and Integrated Good Manufacturing Practices Solutions: A Lifecycle Perspective"],"prefix":"10.1002","author":[{"ORCID":"https:\/\/orcid.org\/0009-0006-2936-8783","authenticated-orcid":false,"given":"Rajath","family":"Samaga","sequence":"first","affiliation":[{"name":"Department of Pharmaceutical Quality Assurance Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education Manipal India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-1567-2232","authenticated-orcid":false,"given":"Udisha","family":"Singh","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Biotechnology Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education Manipal India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9085-029X","authenticated-orcid":false,"given":"Sachin Dattram","family":"Pawar","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Quality Assurance Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education Manipal India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,8,30]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1038\/nbt.3084"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.3390\/cimb47050321"},{"key":"e_1_2_12_4_1","unstructured":"American Society of Gene & Cell Therapy (ASGCT) and Citeline.2025.Gene Cell & RNA Therapy Landscape Report: Q3 2025 Quarterly Data Report.American Society of Gene & Cell Therapy (ASGCT) and Citeline."},{"key":"e_1_2_12_5_1","unstructured":"Project A\u2010Gene Alliance for Regenerative Medicine (ARM).2021.A\u2010Gene: A Case Study\u2010Based Guide to Integrating Quality by Design (QbD) Principles in Gene Therapy Chemistry Manufacturing and Controls (CMC) Programs. 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