From the Editors: LPC Snapshot publications and AABB-ISCT Joint Working Group

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Michele Sugrue MS, MT(ASCP)SBB

Remaining open-minded and maintaining objectivity are goals to which I strive in both my personal and professional life. During a heated political discussions at a family gathering or while reviewing a manuscript for publication, preconceptions, predispositions and adherence to dogma should all be avoided. But here, I come clean and share my affinity and bias as an ISCT Telegraft Editor and as co-leader of the AABB-ISCT Joint Working Group.

With each edition of the Telegraft, my eyes track firstly to the Laboratory Practices Committee (LPC) Snapshots. Indeed, I find the Snapshots to be much more than their name implies. Experts in the cellular therapy field who serve on the LPC, generously prepare a thorough, yet condensed, assessment and review of timely topics, which are of great interest to the scientific community at large . The content of each topic provides the reader with practical material formatted in a manner to facilitate efficient comprehension. Snapshots offer invaluable information that can be applied at the bench, in the clinic and during collection of cellular therapy products.

Just recently, Yvette Tanhehco PhD, MD, MS prepared an exceptional distillation of environmental monitoring, applicable regulatory and accrediting requirements, predetermined testing specifications and data retrieval systems. In addition, a number of contributions aimed to provide descriptions of validation and qualification studies have been published in the Telegraft. For examples, Cheryl Cox, MT(ASCP), CSSMBB presented details of a cellular product thawing comparison between three different methodologies and equipment, Sufira Kiran DCLS, BS, MLS(ASCP)^CMdescribed vendor qualification under FDA regulations and ICH/ ISO guidelines, and Gloria Carmona Sanchez MSc, PharmG offered an in depth example of an aseptic process validation, also known as “media fill”

Below are just a few more of past and upcoming topics to exemplify the breadth and practicality of the LPC Snapshots. I kindly encourage you to head to the Telegraft Hub archives (https://www.isctglobal.org/telegrafthub/news-hub/labpractices) to explore additional key topics prepared by our exemplary colleagues.

Endotoxin Testing and Validation by: Sufira Kiran DCLS, BS, MLS(ASCP)^CM
Potency Testing in Cell and Gene Therapy Products By: Ted Kieffer, MD, MS
Exploring Manufacturing Options for Engineered T-cell Therapies By: Hannah W. Song, Ph.D
Cell Processing Labs and COVID-19: Challenges and Quality of Cryopreserved HPC Products, Our Experiences from Australia by: Vicki Antonenas MSc, BSc.
Cell Counting Methods: Automation vs. Manual by: Darcie Radel MT(ASCP)

I hope that highlighting these representative snapshots has whet your appetite and you will directly click on the link the newest LPC Snapshot next time you open Telegraft.

Next, please allow me to share another precious ISCT source of practical knowledge. The AABB-ISCT Joint Working Group was formed in 2014, for the purpose of identifying issues common to both organizations in the cellular therapy arena through which both organizations collaborate. During the past few years, projects of mutual interest have been led by heroic co-leaders and project teams who devoted many hours of work (outside of their day jobs) to fulfilling predetermined deliverables. The project outputs are available to the membership of AABB and ISCT and offer in-depth appraisals of current, critical topics including:

1.

Identification of gaps in the field of pooled human platelet lysate (pHPL) and the barriers to translational use in production of clinical grade cell therapy products. This publication addresses issues concerning production and standardization of pooled HPL based on the increasing need for a non-animal derived source. Bieback K, Fernandez-Muñoz B, Pati S, Schäfer R. Cytotherapy. 2019 Sep;21(9):911-924. https://doi.org/10.1016/j.jcyt.2019.06.006.
Creation of roadmap path towards standardization of cryopreserved hematopoietic stem/progenitor cell (HSPC) stability programs. This report assesses current practices, focused on cryopreserved HSPC cell therapy products and establishes recommendations for a stability program. Reich-Slotky R, Vasovic LV, Land KJ, Halpenny M, Woeltz J, Mathew AJ, Fournier D, Alder B, Stasko K, Mahmud N. Cytotherapy. 2022 May;24(5):473-481. https://doi.org/10.1016/j.jcyt.2022.03.001.
Development of a comprehensive section-by-section GTP Interpretative Tool guidance specific to the needs of a cell therapy programs in order to achieve regulatory compliance and preparation for unannounced FDA inspections. The tool is available on the ISCT website for access by active members. https://www.isctglobal.org/resources/gtp-interpretive-tool
Creation of a Quality Agreement Template that identifies key quality, regulatory and responsibilities between the sponsor and the collection/processing facilities during collection, processing, and shipping of starting material for further manufacturing, and the receipt, storage, and infusion of Drug Product (DP) to be used in an investigational protocol (research) or standard of care (commercial) treatment (in progress).

In addition, I could not be prouder to have played a (small) part in the co-publication of the two peer reviewed articles and the invaluable comprehensive GTP Interpretative tool. The highly anticipated comprehensive and customizable Quality Agreement is underway and its completion and availability is expected before the end of 2023.

As you can see and probably already know, our ISCT colleagues continue to provide these valuable resources through their generous time and effort and for that I am grateful. Please take time to read a Snapshot, refer to a co-publication and review the GTP Interpretative Tool to join me in recognizing ISCT’s biggest asset, our membership!