Key considerations of cell and gene therapy cold chain logistics

Meacle, Francis; Salkin, Jeff; Rice, Meredith; Harris, Ian R.

doi:10.18609/cgti.2016.025

Cited by 4 publications

(3 citation statements)

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“…Equipment to achieve this is available. Operation in this way should secure a tightly linked cryochain that can provide safe, multiple movement of frozen samples from initial tissue isolation to delivery of prepared, therapeutic materials to the patient ( 180 ).…”

Section: Handling Extended Storage and Transportmentioning

confidence: 99%

Cryopreservation as a Key Element in the Successful Delivery of Cell-Based Therapies—A Review

2020

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Cryopreservation is a key enabling technology in regenerative medicine that provides stable and secure extended cell storage for primary tissue isolates and constructs and prepared cell preparations. The essential detail of the process as it can be applied to cell-based therapies is set out in this review, covering tissue and cell isolation, cryoprotection, cooling and freezing, frozen storage and transport, thawing, and recovery. The aim is to provide clinical scientists with an overview of the benefits and difficulties associated with cryopreservation to assist them with problem resolution in their routine work, or to enable them to consider future involvement in cryopreservative procedures. It is also intended to facilitate networking between clinicians and cryo-researchers to review difficulties and problems to advance protocol optimization and innovative design.

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Section: Handling Extended Storage and Transportmentioning

confidence: 99%

Cryopreservation as a Key Element in the Successful Delivery of Cell-Based Therapies—A Review

2020

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“…Starting materials are commonly shipped fresh at ambient temperatures or hypothermic in autologous plasma at 4°C. Similar to cell therapy final products however, given limits to their shelf-life and stability, high demand for access to products, and the risk of diminishing quality and consistency, other options should certainly be considered [5]. For final product stability, cryopreservation has subsequently become a more standard approach to ensure stability and consistency are maintained (e.g., Novartis' Kymriah and Kite's Yescarta).…”

Section: Impacting Stabilitymentioning

confidence: 99%

“…Historically, the cell therapy industry has invested a great deal of time and capital into logistical issues and much of this has focused primarily on biopreservation of the final product and maintaining the cold chain [4,5]. Solution providers in North America, maybe on the same coast or at worst, going from one coast to the other.…”

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confidence: 99%

Managing starting material stability to maximize manufacturing flexibility and downstream efficiency

Clarke¹,

Smith²

2019

Cell Gene Therapy Insights

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The cell and gene therapy industry is filled with excitement and promise as recent clinical and commercial successes have made headlines worldwide. New therapies are entering clinical trials like never before [1]. With this growth comes underlying challenges, some of which are obvious and well documented, such as scale-up manufacturing and the need for cost of goods reduction [2] -but others are perhaps not currently given the amount of attention they deserve or require. Two such challenges are the increasing demand for quality starting materials and the logistical issues in getting those products that are typically shipped fresh from the clinic or donor processing center to the manufacturing facility [1,3,4]. There are many time-sensitive elements within the cell and gene therapy supply chain and these present critical challenges. This article will explore some specific examples and look at how the industry can address them by improving quality and consistency of starting materials and reducing some of the existing bottlenecks which may impact downstream manufacturing and therapeutic success.

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An industry survey of implementation strategies for clinical supply chain management of cell and gene therapies

Myles

Church

2022

Cytotherapy

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Key considerations of cell and gene therapy cold chain logistics

Cited by 4 publications

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Cryopreservation as a Key Element in the Successful Delivery of Cell-Based Therapies—A Review

Cryopreservation as a Key Element in the Successful Delivery of Cell-Based Therapies—A Review

Managing starting material stability to maximize manufacturing flexibility and downstream efficiency

An industry survey of implementation strategies for clinical supply chain management of cell and gene therapies

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