When a patient’s cells are collected for a cell therapy clinical trial, every minute between collection and processing matters. Delays during transit — even a few hours — can degrade cell viability, compromise downstream manufacturing, and ultimately threaten the success of a clinical program.[1][2] Co-located cell collection and processing facilities address this challenge directly by housing apheresis collection and cell processing under one roof.
What Does “Co-Located” Mean in Cell Therapy?
In the context of cell and gene therapy, a co-located facility is one where donor or patient cell collection (leukapheresis or apheresis) and subsequent processing operations (PBMC isolation, cell selection, cryopreservation) occur at the same site. Rather than collecting cells at one location and shipping them to a separate processing laboratory, a co-located model eliminates transit entirely — cells move from the collection chair to the processing suite within minutes.
This model stands in contrast to the traditional approach used by many contract development and manufacturing organizations (CDMOs), where apheresis centers and processing labs may be in different cities or even different states, requiring overnight shipping of temperature-sensitive biological material.[3]
How Transit Time Affects Cell Viability
Published research consistently demonstrates that cell viability degrades over time after collection. According to guidance published in Cytotherapy by the International Society for Cell & Gene Therapy (ISCT), leukapheresis product performance is negatively affected by longer time between collection and cryopreservation, with significant loss in both cell viability and function occurring over the initial 24–48 hours post-collection.[1] Analysis of data from the ELIANA and JULIET clinical trials of tisagenlecleucel demonstrated that hold times longer than 24 hours before freezing had a negative effect on post-thaw cell viability and significantly reduced post-thaw cell recovery by up to 20% in patients with DLBCL.[1]
The biological mechanism behind this degradation is well understood. Granulocytes present in leukapheresis products are short-lived and prone to rapid apoptosis. As they die, they release reactive oxygen species that damage neighboring cells. This process accelerates viability loss, especially when transport and processing are delayed.[4]
Industry best practice recommends that leukapheresis products be transported at room temperature (15–25°C) and processed within 24 hours of collection to preserve cell integrity.[1][5] A separate study published in Cytotherapy found that three-day storage of leukapheresis material significantly lowered dendritic cell yield and impaired DC responses to inflammatory signals, recommending use of leukapheresis materials within 48 hours.[2] Co-located facilities dramatically shorten this window — in some cases to under 30 minutes — providing a measurable advantage in preserving the quality of the starting material.
The Clinical Advantages of Co-Location
Preserved Cell Viability and Function
The most direct benefit is higher cell viability at the point of cryopreservation or downstream manufacturing. When cells spend minutes rather than hours in transit, they retain their phenotypic characteristics, proliferative capacity, and functional potency. For autologous therapies like CAR-T, where the patient’s own cells serve as starting material, this can be the difference between a successful manufacturing run and a failed batch.[4][6]
Simplified Chain of Custody
Cell therapy chain of custody is one of the most complex logistical challenges in the industry. Every handoff between facilities introduces risk — temperature excursions during shipping, documentation gaps, mislabeling, and delays.[7] A co-located model reduces these handoffs to internal transfers within a single facility, all governed by one quality management system. As noted by TrakCel, controlling chain of custody decreases the risk of excursions damaging starting material and increases the probability that the therapy will meet release specifications.[8]
Regulatory Simplification
When collection and processing occur under one FDA-registered facility operating under 21 CFR Part 1271, the regulatory oversight model is unified. A single facility manages both functions under one quality system, rather than requiring coordination between multiple registered sites with separate standard operating procedures, audit histories, and compliance records. This reduces complexity for both the manufacturer and the clinical trial sponsor during IND submissions and FDA inspections.
Faster Turnaround for Time-Sensitive Therapies
For patients with aggressive hematologic malignancies awaiting CAR-T therapy, manufacturing timelines are critical. Prolonged manufacturing and release times frequently range from two to four weeks,[9] and the overall vein-to-vein time can range from 3–5 weeks with a median of 31 days.[10] Patients with progressive disease may decline clinically during this period — as reported by Schuster and colleagues, 33% of patients with LBCL who undergo leukapheresis do not reach CAR-T cell infusion.[11] Co-located processing removes transit delays from the equation entirely, shaving hours or days off the front end of the manufacturing timeline.
How Does the Industry Currently Approach This?
The cell therapy industry takes varying approaches to the collection-to-processing workflow. Some organizations operate dedicated collection centers co-located with processing laboratories, while others coordinate between separate apheresis centers and centralized manufacturing sites.
Large CDMOs often maintain centralized manufacturing hubs with collection coordinated through networks of apheresis centers. This model works for scale but introduces shipping logistics, cold chain management, and multi-site coordination challenges.[7][12] Smaller, specialized providers have increasingly adopted the co-located model, recognizing that proximity to collection is a competitive differentiator — particularly for clinical-stage programs where every batch matters.
What to Look for in a Co-Located Processing Partner
Not all co-located facilities are equal. When evaluating a processing partner, clinical trial sponsors should assess several factors. First, confirm that the facility is FDA-registered and operates under a unified quality management system covering both collection and processing. Second, ask about actual processing timelines — how quickly do cells move from the collection chair to the processing suite? Third, evaluate the facility’s cryopreservation capabilities and cold chain documentation.[7] Finally, consider geographic coverage — a co-located model is most beneficial when facilities are accessible to the patient populations enrolled in the trial.
The Future of Cell Therapy Logistics
As the cell therapy industry matures from early clinical trials toward commercialization, the logistics of starting material handling will become increasingly important. The trend toward decentralized and co-located processing models reflects a broader recognition that the quality of the starting material is foundational to the quality of the final therapeutic product.[3][12] Facilities that minimize the gap between collection and processing are positioned to deliver better outcomes — for manufacturers, for sponsors, and ultimately for patients.
Ready to accelerate your cell therapy program? Contact OrganaBio at organabio.com to speak with our team.
References
[1] Allen ES, et al. “Leukapheresis guidance and best practices for optimal chimeric antigen receptor T-cell manufacturing.” Cytotherapy, 2022. doi:10.1016/j.jcyt.2022.05.003
[2] Chen P, et al. “A critical time window for leukapheresis product transportation to manufacture clinical-grade dendritic cells with optimal anti-tumor activities.” Cytotherapy, 2024;26(4):365–375. doi:10.1016/j.jcyt.2023.12.005
[3] Cryoport Systems. “Development of an automated cryopreservation process for leukapheresis to support CGT supply chain.” Cytotherapy, 2024;26(6):S29. doi:10.1016/j.jcyt.2024.03.051
[4] Reddy OL, Stroncek DF, Panch SR. “Improving CAR T cell therapy by optimizing critical quality attributes.” Seminars in Hematology, 2020;57(2):33–38. doi:10.1053/j.seminhematol.2020.07.005
[5] Liu HD, et al. “Considerations for immune effector cell therapy collections: a white paper from the American Society for Apheresis.” Cytotherapy, 2022;24(7):665–686. doi:10.1016/j.jcyt.2022.03.004
[6] Bornstein S, et al. “Early predictive factors of failure in autologous CAR T-cell manufacturing and/or efficacy in hematologic malignancies.” Blood Advances, 2024;8(2):337–350. doi:10.1182/bloodadvances.2023011690
[7] Cell & Gene Therapy Insights. “Key considerations of cell and gene therapy cold chain logistics.” Cell & Gene Therapy Insights, 2016.
[8] TrakCel. “What is Chain of Custody (COC) in CGT?” TrakCel.com, 2024.
[9] Hernandez-Lopez A, et al. “Promises and challenges of a decentralized CAR T-cell manufacturing model.” Frontiers in Transplantation, 2023;2:1238535. doi:10.3389/frtra.2023.1238535
[10] Sharma A, et al. “Full speed ahead: how rapid CAR-T manufacturing can shape the cell therapy landscape.” Cell & Gene Therapy Insights, 2025.
[11] Roddie C, et al. “Accelerating and optimising CAR T-cell manufacture to deliver better patient products.” Lancet Haematology, 2024. doi:10.1016/S2352-3026(24)00273-4
[12] Cell & Gene Therapy Cold Chain. “Key requirements, challenges, and innovations.” CellandGene.com, 2024.
