An Update on Cell Therapy News from AABB | JULY 2019
IN THIS ISSUE
Registration for AABB eCasts
is available for both individuals and groups, and institutions can host eCasts for employees at one or more sites. Participants in group eCasts are eligible to earn continuing education credit. On-Demand
recordings of eCast sessions are available for those unable to attend a live eCast.
Cellular Therapies Certificate Program: CME Opportunity for CT Professionals
The AABB Cellular Therapies Certificate Program, produced in partnership with the George Washington University, is a self-paced, online program designed for professionals interested in expanding their knowledge of CT. The award-winning program features 12 narrated modules covering scientific, operational and regulatory topics. Students who work through the modules, complete each assessment with a score of 80% or higher and complete a program evaluation form will receive a certificate of completion. The program also provides an opportunity to earn up to 37 CME continuing education credits (CMEs).
Christina M. Celluzzi, PhD, MS
Kathy Loper, MHS, MT(ASCP)
AABB Center for Cellular Therapies
4550 Montgomery Avenue Suite 700, North Tower
Bethesda, MD 20814
Joint AABB and Be The Match BioTherapies Pre-Meeting Workshop to Address Manufacturing Cellular Therapies
AABB and Be The Match BioTherapies have teamed together to present “Manufacturing Cellular Therapies: Challenges, Solutions and Creating Synergy for Success," a workshop to be held on Oct. 18 preceding the start of the AABB Annual Meeting in San Antonio. This interactive workshop will unpack real-world scenarios highlighting the challenges of implementing cellular therapies across various settings and business models — exploring the perspectives of hospitals, blood centers and small startup companies with both centralized and decentralized manufacturing models.
The full agenda, with world-renowned faculty, is coming soon. Individuals can register for the cellular therapies workshop alone or add it to their annual meeting registration. Early bird pricing is available until July 31, so register today!
Opportunities Available for CT Section Members to Be a Part of Section Leadership
AABB’s Cellular Therapies Section is accepting applications from current members of any CT subsection who are interested in seeking election to the CT Section Coordinating Committee, or CTSCC for the upcoming term. The CTSCC works collaboratively to lead subsections, set priorities and support CT Section members – providing valuable leadership experience plus the opportunity to network and to enhance industry knowledge. Interested CT Section members should send a message to email@example.com by Aug. 31 stating their intention to seek election, listing subsection areas of interest and describing — in 250 words or less — their relevant experience and potential to contribute to the CT Section. The email should include a photo, as well. To ensure fairness, submissions exceeding the word limit will not be accepted. AABB will acknowledge submissions with an email. The election will be held by electronic ballot. Results will be announced in October during the CT Section Business Meeting in San Antonio. AABB strongly encourages international participation.
4th Conference in Cellular Therapeutics in Trauma and Critical Care Series Will Highlight State of the Science and Barriers in Trauma and Critical Care
Cellular therapies, adjuncts to resuscitation and novel blood products represent critical areas in transfusion medicine that have the potential to dramatically improve outcomes in trauma patients and are expected to change the face of transfusion medicine around the world in the future. Cellular Therapies and Transfusion Medicine in Trauma and Critical Care Medicine, the fourth conference dedicated to the topic, will be held Dec. 11-13 in San Diego. The goal of this meeting is to bring together the expertise and input of a multidisciplinary group of blood bankers, clinicians, basic scientists, industry experts, academics and FDA, NIH, AABB, BARDA and DOD representatives to discuss the state of the science and barriers hindering the translation of these novel therapies in trauma and critical care. The conference will cover cellular therapies, novel blood products and transfusion-related topics. More information is available online.
Reimagining AABB: Next Steps - Check Out the Video
FDA Announces New Program to Help HCT/P Manufacturers
FDA announced a temporary new program to help manufacturers of human cells, tissues, and cellular and tissue-based products (HCT/Ps) obtain a rapid, preliminary, informal, non-binding assessment from FDA regarding how specific HCT/Ps are regulated. The program, the Tissue Reference Group (TRG) Rapid Inquiry Program (TRIP), went into effect June 12 and will operate until Dec. 31. Information on how to submit a TRIP request is available online.
FDA Announces Project to Assist Physicians Seeking Access to Unapproved Cancer Therapies
FDA’s Oncology Center of Excellence announced a new pilot program to assist oncology health care professionals in requesting access to unapproved therapies for patients with cancer. The project includes a call center — Project Facilitate — to serve as a single point of contact for FDA oncology staff to help physicians treating patients with cancer go through the process of submitting an Expanded Access request for an individual patient, including follow-up of patient outcomes. The pilot program includes a central office for oncology requests enabling FDA to follow up on individual requests and gather data. FDA can use this data to determine how the process is benefiting patients and health care professionals. FDA’s Expanded Access is relevant for providers who have a patient with a critical or serious disease or condition, to whom it provides access to an investigational medical product (drug, biologic or medical device) for treatment outside of clinical trials when there are no comparable or satisfactory alternative therapy options available. Additional information about this program is available online.
Antibody Conditioning Enables MHC-Mismatched Hematopoietic Stem Cell Transplants and Organ Graft Tolerance
George et al found in a murine model that pre-treatment with a combination of six monoclonal antibodies targeting CD47, T cells, NK cells, and HSCs followed by donor HSC transplantation enabled stable hematopoietic system reconstitution in recipients with mismatches at half (haploidentical) or all major histocompatibility complex (MHC) genes. This approach allowed tolerance to heart tissue from HSC donor strains in haploidentical recipients, showing potential applications for solid organ transplantation without immune suppression. If reproducible in humans, the research shows great promise for treating certain immune and blood disorders with allogeneic therapies and for increasing the number of organs available for patients requiring transplantations.
Leukocyte Composition Used in Manufacturing CAR T Cells Affects Cell Expansion and Product Composition
Autologous chimeric antigen receptor (CAR) T cells have shown promising clinical results for treating hematologic malignancies. While CAR T cells are in general clinically effective, for some patients, initial attempts to manufacture CAR T cells have failed. Elavia et al, using density cell gradient separation and anti-CD3 stimulation for CAR T-cell culture and expansion initiation, show that composition of leukocytes can affect cell expansion and the composition of CAR T cell products. Evaluating 51 CAR T cell products, they found reduced expansion when greater quantities of monocytes were present post-density gradient separation. Greater quantities of monocytes and RBCs were associated with a greater proportion of CD4+ cells, and greater quantities of neutrophils were associated with a greater proportion of CD8+ cells. Uniform or complete lymphocyte enrichment of peripheral blood mononuclear cells is necessary to improve the consistency of final CAR T cell products.
Mesenchymal Stromal Cell Homing: Mechanisms and Strategies for Improvement
Mesenchymal stromal cells (MSCs) have been widely investigated for their therapeutic potential in regenerative medicine, owing to their ability to home damaged tissue and serve as a reservoir of growth factors and regenerative molecules. Clinical applications of MSCs rely on these cells to migrate successfully to the desired tissue following their administration. A variety of strategies have been employed in the hope of improving this process. Ullah et al review the molecular mechanisms underlying MSC homing based on a multi-step model involving (1) initial tethering by selectins, (2) activation by cytokines, (3) arrest by integrins, (4) diapedesis or transmigration using matrix remodelers, and (5) extravascular migration toward chemokine gradients — further reviewing the various strategies that have been investigated for improving MSC homing including genetic modification, cell surface engineering, in vitro priming of MSCs, and ultrasound techniques.
AABB's Standards for Cellular Therapy Services, 9th edition, may now be purchased in the AABB Marketplace. The 9th edition is available as an electronic version that is housed in the AABB Standards Portal, a printed version or a bundle of the two. AABB offers a complimentary two-week trial in the Standards Portal that gives new users full access to the Standards, allowing them to experience its full functionality. Features added to improve user experience include the ability to personalize a user profile that is specific to the activities performed at a given facility, a robust search function and direct links to additional information.
New for this edition of the Standards and now available for purchase, is a printed version of the “Guidance for Standards for Cellular Therapies Services.” This Guidance provides users with information on the meaning and requirements of each associated standard, as well as examples of how to meet the standards.
Applications for NBF Grants Being Accepted
CT Mentors Needed for PEP Mentoring Program
AABB encourages members with more than 5 years’ experience in the cellular therapies field to consider joining the Professional Engagement Program (PEP) Mentoring program. The informal, 6-month program provides a way for AABB members to share their expertise, expand their professional network and engage in an exchange of ideas. Mentors and mentees communicate at least once per month by phone. Individuals interested in participating can apply by completing an online application.
Results of Joint AABB-ISCT Working Group to Be Presented in Complimentary Webinar
Human platelet lysate (hPL) is a human product that can be produced from outdated platelets, thus avoiding ethical, medical and animal welfare concerns. An increasing number of studies demonstrate that hPL promotes cell growth similarly to or even better than fetal bovine serum in specific cell types. A complimentary webinar, Gaps in the Knowledge of Human Platelet Lysate as a Cell Culture Supplement for Cell Therapy is scheduled for July 17, 12 noon ET. Jacques Galipeau, MD, and Karen Bieback, PhD, will provide an overview of hPL, identifying the gaps in information on how hPL is produced and tested and the barriers to its translational use in producing clinical grade cell therapy products. Bieback who served as leader of the joint AABB-ISCT working group’s human platelet lysate (hPL) project team, will present results from the working group. The hPL project team activity is part of a collaboration established between AABB and ISCT to develop projects of mutual interest to the two organizations. Lizette Caballero, BS, MT(ASCP), of the UCSF Medical Center and ISCT Co-Chair of the AABB-ISCT Joint Working Group, will be directing the session.
FDA Posts Resources for Regenerative Medicine
A list of FDA resources for regenerative medicine (RM) is available online. Topics include FDA’s framework for the regulation of RM products, the Agency’s Regenerative Medicine Advanced Therapy (RMAT) designations, guidances on the development of RM therapies, CBER standards development activities, CBER workshops, meetings and conferences, and webcasts.
Regenerative Medicine Standards Landscape Document Outlines Existing Standards
In consultation with the National Institute of Standards and Technology (NIST) and stakeholders, FDA is facilitating efforts to coordinate the development of standards for RM therapies. Nexight Group and the Standards Coordinating Body (SCB) are coordinating community efforts to develop standards for RM therapies. Nexight has utilized public workshops and webinars to help develop processes enabling the identification of needed standards and to facilitate the development of standards that will have a high impact on the quality and safety of RM therapies. Nexight published The Regenerative Medicine Standards Landscape, which outlines existing standards that apply to analytical testing, bioprocessing, product quality, and preclinical and clinical studies. FDA updates the document annually; it is available on the SCB website. A list of workshops supporting standards development can be found on the FDA website.
Grant Funding Opportunity Announcements Available on NIAID Website
Members of the AABB Center for Cellular Therapies' subsections meet regularly via teleconference to participate in interactive activities, including developing tools and reference materials, as well as discuss CT topics. For more information visit www.aabbcct.org.
The Latest on CT Subsection Activities
The AABB Center for Cellular Therapies encourages members to enroll in subsections to enrich their professional experience. An assortment of materials presented on the monthly calls can be found on the CCT projects’ website.
QRM: The QRM subsection discussed regulatory challenges, current guidances and issues related to managing a cell therapy facility.
Cord Blood: Discussion covered topics on a wide range of issues, including nucleated red blood cells as a novel indicator of CD34+ cell content in umbilical cord blood and cleaning agent selection and evaluation. Guest speaker Kate Falcon Girard, RN, MSN, presented Timing of Cord Clamping and its Impact on Cord Blood Collection.
Spanish Language Subsection (SLS): The SLS subsection is conducted entirely in Spanish. Presentations can be found on the projects web page.
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