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Press Release

Essential Cell Collection Considerations for Immune Cell Therapy

Article #2 in the Series: Transforming Insights Into Action

​In our first article in this series, we introduced the Terumo Research Institute (TRI) and its role in industry education and leadership. Now, we turn our attention to a recent example – where TRI is making best practices in cell collection a part of the Quality by Design discussion in a recently published industry handbook, A‑Cell.1

Cell Therapy Case Study Approach Focuses on CAR-T
A-Cell is an 11-chapter "case study-based approach to integrating Quality by Design2 principles in Cell-based Therapy CMC programs" published by the Alliance for Regenerative Medicine (ARM), the industry's leading international advocacy organization, and the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), a U.S.-based public-private partnership. It's designed to elevate best practices in the cell and gene therapy (CGT) field globally by providing a consolidated set of recommendations for every aspect of cell-based therapy chemistry, manufacturing, and controls (CMC).

As innovation and production scaling in the cell therapy industry grows, A-Cell offers in-depth discussions of regulatory considerations, standards, best practices, materials, facility design, and more. To help provide focus, it addresses a single hypothetical use case – CAR T-cell therapy.

Dalip Sethi, PhD, Director, Scientific Affairs, Cell Therapy Technologies/Innovation for Terumo Blood and Cell Technologies​, explains, "Cell therapy is complex. There are so many varied protocols and complicated processes, and every biotech is using a different process. A-Cell is an attempt to give some guidance to address the question, how can standardized methods be developed in this space?" Expert contributors and reviewers are a who's who of industry leadership.   

Cell Collections Are New Territory for Some
While cell and gene therapy developers are experts in cell modification and expansion, they often rely on third parties to provide starting material. That means they may not be familiar with all the nuances of the cell collection process as outlined below — and how working more closely with the collections team can help achieve the best outcomes. That's why Chapter 5, "Cell Collection and Starting Materials Consideration," is so important. And because of Terumo Blood and Cell Technologies' more than 40 years of cell collection experience, ARM and NIIMBL turned to the TRI as the logical contributor, says Sethi, one of the chapter's two lead authors.

To ensure high-quality cells at the end of the collection procedure, practitioners navigate the complexities of skillful device operation, patient preparation, and management of the patient's safety and comfort during the procedure. The A-Cell chapter covers best-practice considerations ranging from technical device details and differences between collection protocols to donor screening and regulatory matters. While it describes collection best practices in general, many of the considerations the authors discuss are informed by their experience with the industry-leading Spectra Optia® Apheresis System.

Patient preparation and management — optimal timing for a collection procedure, blood counts, anticoagulant management during collection, and more — are just as important as technical device considerations, says Erin Goodhue Meyer, DO, MPH. Standards development has long been a passion for Goodhue Meyer, who is Director, Clinical Development for Terumo Blood and Cell Technologies and the chapter's other lead author. "Being involved in the development of national and international standards has been ingrained in me since residency. I have collected cells from hundreds of patients on our COBE Spectra Apheresis System and now from hundreds and hundreds of patients on Spectra Optia. The changes in efficiency and safety have opened therapeutic interventions to smaller patients that we never would have been able to collect as safely on other devices. And that's life-changing for patients and their families."

A third author, Elizabeth Valdez, formerly Cell Therapy Operations Manager with Novartis, is now Integration Manager, Therapeutic Systems for Terumo Blood and Cell Technologies. She contributed insight from her many years of experience as an Apheresis Registered Nurse with both adults and children.

Shedding Light on Vascular Access
The chapter emphasizes discussing vascular access, which Goodhue Meyer says can be a rate-limiting step, before an apheresis collection. High venous blood flow is needed for up to several hours to collect cells, and there is much to consider, including:

  • Type and duration of donation or treatment
  • Need for additional intravenous interventions, such as medication
  • Patient's age and size
  • Diagnosis/clinical condition

Each choice has implications for the patient's comfort, and patients do have preferences. "I wanted to underscore the importance of having clear discussions with the patient and their family up front. We can never forget the importance of vascular access," says Goodhue Meyer.

Download A-Cell
A-Cell is available as a free download​ to benefit the industry globally. "At Terumo Blood and Cell Technologies, we have a vision and mission to be not just a maker of devices, but part of the broader ecosystem. And when we think about the ecosystem, and especially in healthcare and technology field, one of the main things that we have to do in the ecosystem is to lead," says Sethi.

Next: An article from lead author Annie Cunningham providing new evidence about the benefits that modular automation may hold for cell health and quality.

1Alliance for Regenerative Medicine (ARM) and National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). A-Cell: A Case Study-Based Approach to Integrating QbD Principles in Cell-Based Therapy CMC Programs. https://alliancerm.org/publications-presentations/. Accessed 15 November 2022.

2Quality by Design (QbD) is defined as "a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management." Source: International Conference on Harmonization (ICH) Q8(R2): Pharmaceutical Development – Guidance for Industry. November 2009. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q8r2-pharmaceutical-development


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