ArticleTransfusion2024
Healthcare center-based cell therapy laboratories supporting off-site manufactured cell therapies: The experiences of a single academic cell therapy laboratory.
Article in Transfusion, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
4 citing papers in PubMed, 5 citations in OpenAlex.
- The clinical quality management system of advanced therapy medicinal products in the hospital setting: A scoping review.Molecular therapy. Methods & clinical development · 2025Review
- Redefining quality in cell and gene therapies: Lessons from implementing electronic QMS in academic cGMP facility.Molecular therapy : the journal of the American Society of Gene Therapy · 2025Review
- Art of TIL immunotherapy: SITC's perspective on demystifying a complex treatment.Journal for immunotherapy of cancer · 2025Review
- Harnessing the promises of cell therapy, gene therapy, and regenerative medicine in Québec, Canada.Frontiers in medicine · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors at 1 institution in 1 country.
Funding
Abstract
backgroundHealthcare center-based cell therapy laboratories (HC CTLs) evolved from solely processing hematopoietic stem cells for transplantation to manufacturing various advanced cellular therapies. With increasing interest in cellular therapy applications, off-site manufactured products are becoming more common. HC CTLs play a critical role in supporting these products by shipping out cellular starting material (CSM) for further manufacturing and/or receiving, storing, and distributing final products. The experiences and challenges encountered by a single academic HC CTL in supporting these products are presented.
methodsAll off-site manufacturing protocols supported before 2023 were reviewed. Collected data included protocol characteristics (treatment indication, product type), process logistics (shipping, receiving, storage, thawing, distribution, documentation), and product handling volumes (CSM shipping and final product infusions).
resultsBetween 2012 and 2022, 15 off-site manufactured cellular therapy early-phase, single- and multicenter clinical trials were supported. Trials were sponsored by academic/research and commercial entities. The number of protocols supported annually increased each year, with few ending. Products included cancer immunotherapies and gene therapies. Autologous CSM was collected and shipped, while autologous and allogeneic final products were received, stored, thawed, and distributed. Process differences among protocols included CSM shipping conditions, laboratory analyses, final product thaw conditions and procedures, number of treatments, and documentation. DISCUSSION: HC CTLs must contend with several challenges in supporting off-site manufacturing protocols. As demand for cellular therapies increases, stakeholders should collaborate from the early phases of clinical trials to streamline processes and standardize procedures to increase value, improve safety, and reduce the burden on HC CTLs.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.