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AABB CellSource - July 2020

AABB Cellsource
An Update on Cell Therapy News from AABB   | JULY 2020

HIGHLIGHTS
IN THIS ISSUE
ANNOUNCEMENTS
Time to Experience The Cellular Therapies Certificate Program?
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 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 continuing education credits (CMEs). 
 
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CT eCasts in 2020:
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.
 
Upcoming CT eCasts include: 
Cellsource
 
Editor:
Christina M. Celluzzi, PhD, MS
 
AABB Center for Cellular Therapies
4550 Montgomery Avenue, Suite 700, North Tower, Bethesda, MD 20814, +1.301.907.6977
 
IN THE NEWS
AABB 2020 Annual Meeting To Go Virtual; Registration Is Open
After carefully considering all options for the 2020 AABB Annual Meeting, the Association has decided that the meeting will proceed as a virtual event, to be held Oct. 3-5. While this was a difficult decision, AABB is excited to learn from and connect with the transfusion medicine and biotherapies community — including students and early-career professionals — in unique ways.

Virtual_2_1632619.jpgTo provide the exceptional learning and community experience that attendees expect from the Annual Meeting, AABB has chosen a state-of-the art virtual meeting platform that combines an innovative learning environment with reliable functionality and intuitive navigation. The schedule will include a mix of live and on-demand sessions, along with an interactive exhibit hall, networking spaces and poster hall.

In addition, AABB will offer 24-hour access to the virtual Annual Meeting platform — allowing attendees to learn and engage at their own pace. Attendees will also be able to access the platform for an additional month after the meeting ends, while on-demand access will be available for 2 years.

Virtual registration is open. Individuals who previously registered for the in-person event have the option of receiving a full refund, applying the payment to the virtual meeting registration and receiving a refund for the difference, or donating a portion of their refund to AABB. Additional information, including frequently asked questions, is available online. AABB will provide ongoing updates about the 2020 Annual Meeting as planning continues. Early-bird registration ends Aug. 19.
AABB Accepting Late-Breaking Abstracts for 2020 Annual Meeting 
AABB is accepting late-breaking abstract submissions for the 2020 AABB Annual Meeting through July 31. In doing so, the Association seeks to provide a platform for investigators to present research for which results may not have been available during the general submission period that ended May 15. While the Association expects that many late-breaking abstracts will reflect research related to COVID-19, AABB encourages submissions on all topics. Due to these unique circumstances, AABB is allowing COVID-19-related abstracts that were submitted during the general abstract submission period to be resubmitted as late-breaking abstracts if the data and research have been expanded since the original submission. AABB asks investigators who submit late-breaking abstracts to explain why their abstract was not submitted by the general submission deadline. Abstracts that have been published, presented, or accepted for publication or presentation prior to July 31 will not be considered. Additional information is available in AABB’s late-breaking abstract guidelines. Interested individuals may submit their abstracts online.
Opportunities Available for CT Section Members to Be Part of Section Leadership!
Leadership2_215402.jpgAABB’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 (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 contact celltherapy@aabb.org 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. 
Proposed 10th edition of Standards for Cellular Therapy Services Open for Comment
The proposed 10th edition of Standards for Cellular Therapy Services is available for public comment through Sept. 3, 2020. A summary of significant changes is available on the AABB website to facilitate review of the proposed Standards. After the comment period ends, the Cellular Therapy Services Standards Committee will review all comments. The 10th edition will go into effect on July 1, 2021.

To Comment on the Proposed Standards:
  1. Submit comments by Sept. 3, 2020 through the fillable form. Users can also submit comments via email to standards@aabb.org.
  2. Include name and postal address/fax number/email address, as appropriate.
  3. Identify the standard by its number at the beginning of the comments. This identification is especially helpful if you comment on more than one standard.
  4. Provide alternative wording if thought to improve the clarity of a standard. 
  5. If there is strong agreement or disagreement with a proposed change, state reasons why and/or submit data.
Preparation for World Cord Blood Day Underway
CellSource_WBD_logo_copy_142120.jpgWorld Cord Blood Day (WCBD) will be celebrated on Nov. 17. AABB, as an inspiring partner, participates in activities involving cord blood, including discussions on Twitter and other social media platforms. AABB has long supported the promise of cord blood, as demonstrated in its cord blood subsection — which was established in 2009 and continues to facilitate discussions on challenges, protocols and research findings that help to promote the value of cord blood and highlight its immunotherapeutic promise. AABB encourages readers to watch for a special offer in the coming months to ring in WCBD. 

WCBD 2020 will feature a complimentary two-part online virtual conference: 1) LIVE STREAM! A 1-hour live streaming event on Facebook (10 a.m. ET on Nov. 17) and 2) ON-DEMAND Presentations! A spotlight on cord blood experts, transplant doctors and cord blood recipients with in-depth presentations and discussions. More information on the virtual conference as well as global events can be found on the WCBD site www.worldcordbloodday.org
Cord Blood Connect International Congress to Go Virtual
CBC_2_1632367.jpgCord Blood Connect is an international congress that embraces all components of the cord blood community — public and family banking, clinical and laboratory investigations, manufacturing, administration, training, and education. This year, the meeting will convene virtually — meeting live on Thursday, Sept. 10 and Thursday, Sept. 17. This schedule takes advantage of the online format: The congress sessions will be webcast live from 10 a.m.-5 p.m. in the Eastern time zone of North America, which will be 5 p.m.-midnight in central Europe. For Asia, Australia and the Pacific Rim, the programming will be re-transmitted overnight so it can be seen from 7 a.m.-2 p.m. in Beijing, 8 a.m.-3 p.m. in Tokyo and 9 a.m.-5 p.m. in Sydney. All sessions will also be archived for on-demand viewing by congress registrants in the weeks and months after the live webcasts.
SCB Opens Survey of Industry and Apheresis Cell Collection Center Professionals 
The Standards Coordinating Body (SCB) has opened a survey to seek input from apheresis cell collection centers and industry on current cell collection practices to contribute to new standards in this area. The growth of the cell and gene therapy fields has increased the burden on both apheresis cell collection centers and industry. Improved consistency through standardization of some common collection parameters may reduce this burden. Standards could increase product quality, reduce errors, and audit fatigue, and potentially improve patient outcomes. The SCB developed these surveys through close collaboration with a working group of experts from industry, apheresis cell collection centers, processing laboratories, accreditation bodies, research centers and other stakeholders. The survey will run through Aug. 7, 12 midnight ET.

Survey For Industry: https://cell-collection-for-industry.questionpro.com
Survey For Apheresis/Cell Collection Centers: https://apheresis-center-survey.questionpro.com
Best Practices Approach on How to Prepare, Cryopreserve, and Recover Cells, Cell Lines, and Cell-Based Tissue Products Available for Public Comment
The Parenteral Drug Association (PDA) recently announced the availability of the draft document, “BSR/PDA Standard 02-201x, Cryopreservation of Cells for Use in Cell Therapies, Gene Therapies, and Regenerative Medicine Manufacturing: An Introduction and Best Practices Approach on How to Prepare, Cryopreserve, and Recover Cells, Cell Lines, and Cell-Based Tissue Products,” for public comment. This standard is designed to provide guidance on best practice approaches to develop a robust protocol for the reliable freezing, storage, and recovery of cells intended for clinical applications. Interested individuals may receive a copy of this free draft by completing a form on the PDA website. All draft comments should be sent to standards@pda.org. The public commenting period concludes on Sept. 7, 2020.
Applications for NBF Grants Being Accepted
NBF encourages innovation through early-career scientific research grants and strategic research and education grants. Both grant programs support AABB’s mission to further develop transfusion medicine, cellular therapies, and regenerative medicine science. Applications for 2021 grants will be accepted until Dec. 1, 2020. Past grant recipients can be found online.
REGULATORY AND GOVERNMENT UPDATE
Program to Assist Cellular Therapy Manufacturers Extended
FDA extended the agency’s TRIP program to help manufacturers of HCT/Ps obtain a rapid, preliminary, informal, non-binding assessment from FDA regarding how specific HCT/Ps are regulated. The program will operate until March 31, 2021. Instructions for submitting a TRIP request are available online.
FDA Releases Updated Information for HCT/P Establishments Regarding the COVID-19 Pandemic
The Food and Drug Administration recently released updated considerations for facilities involved in the transplantation, infusion or transfer of human cells, tissues or cellular or tissue-based products (HCT/Ps) related to donor screening. FDA is aware that some HCT/P establishments are considering additional donor screening and testing measures in response to the COVID-19 pandemic, but the agency does not recommend using laboratory tests to screen asymptomatic HCT/P donors.

FDA reiterated that HCT/P establishments must determine and document the eligibility of cell and tissue donors. Important considerations include whether, in the 28 days prior to HCT/P recovery, the donor has cared for, lived with or had close contact with someone diagnosed with or suspected of having COVID-19 infection; has been diagnosed with or suspected of having COVID-19 infection; or has had a positive diagnostic test for SARS-CoV-2 but never developed symptoms. The agency will continue to monitor the situation and issue updates as information becomes available.
Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing
FDA has issued a final guidance for responding to COVID-19 infections in employees.
FDA Adds Licensed Donor Screening Tests to HCT/P Donor Testing Web Page
FDA Publishes FRNs for April 2020 CJD, HIV and Malaria Guidance Documents
FDA published Federal Register notices (FRNs) for the April 2020 Creutzfeldt-Jakob Disease (CJD), HIV and malaria guidance documents. In April, FDA released a statement outlining its process for making guidance documents available for immediate implementation to address the urgent need for blood during the COVID-19 pandemic. The process, which follows FDA's established good guidance practices regulations, allowed the agency to issue the HIV and malaria documents without prior public comment. Rather than publishing a separate Notice of Availability (NOA) for each COVID-19-related guidance, FDA stated that it would periodically publish a consolidated NOA. Although issued without prior public comment, FDA is soliciting comments and will review all comments received and revise the documents as appropriate. Each guidance document and FRN specifies the docket number to which comments can be submitted. On June 5, AABB submitted comments on the April 2020 HIV guidance. Members with questions may contact regulatory@aabb.org.

 
RESEARCH FOCUS
Multicenter Evaluation of Heterogeneity in Cellular Therapy Processing Laboratory Procedure Times to Assess Workload Capacity
To operate an efficient and sound business practice from a financial management perspective while simultaneously upholding rigorous safety standards, laboratory leadership must ensure that cellular therapy laboratories (CTLs) evaluate and incorporate appropriate laboratory performance measures, specifically by measuring work capacity and productivity. Growth in size and complexity of clinical hematopoietic progenitor cell (HPC) transplant programs necessitates parallel increases in CTL workload. HPC product processing, typically individually processed, is labor and time intensive. Variation in procedure type and numbers across CTLs complicates direct comparisons, and benchmark data are not readily available. Comparing data from multiple facilities, Thibodeaux et al determined transplant volume and staff numbers. Staff recorded time to perform tasks was broken down into steps: paperwork, product acceptance, transport/infusion, processing, and cryopreservation. Their findings provide information relevant to improve the efficiency of already existing infrastructures for HPC products used as standard of care, allowing for an effort toward developing additional tools to establish internal benchmarks for business activities where industry standards do not exist.
What Does Cell Therapy Manufacturing Cost? A Framework and Methodology to Facilitate Academic and Other Small-Scale Cell Therapy Manufacturing Costings
Recent technical and clinical advances with cell-based therapies (CBTs) hold great promise in the treatment of patients with rare diseases and those with great unmet medical need. Most CBTs are currently developed and manufactured in specialized academic facilities. Due to small scale, unique characteristics and specific supply chains, CBT manufacturing is considered costly compared to more conventional medicinal products. Biomedical researchers and clinicians are increasingly faced with cost considerations in CBT development. Ten Ham et al conducted an international multi-center cost study in four facilities in Europe using eight CBTs as case studies. They proposed a framework and methodology for academic and other small-scale facilities that manufacture CBTs that includes costs from cell or tissue procurement through release of final product for clinical use. 
Universal Treatment For Non-Cancerous Genetic Disorders Using Cord Blood
Researchers at UPMC Children’s Hospital of Pittsburgh found that infusing umbilical cord blood safely and effectively treated 44 children born with various non-cancerous genetic disorders, including sickle cell, thalassemia, Hunter syndrome, Krabbe disease, metachromatic leukodystrophy (MLD) and an array of immune deficiencies. Vander Lught et al created a type of universal treatment with minimal risk to the patients. In the largest trial of its kind to date, participants received intravenous injections of banked cord blood, which was donated from the umbilical cords and placentas of healthy babies just after birth and cryopreserved until needed. Study participants received a low dose of chemotherapy and immunosuppressant drugs in a set sequence. The drugs were tapered off once the cells integrated into the patients’ bodies. Researchers reserved a small fraction of the cord blood and gave it to participants a few weeks after the initial infusion. This procedure did not require the donor and recipient to have matching immune profiles. Overall, post-infusion complications were relatively mild. None of the participants experienced severe chronic graft-versus-host disease and the mortality rate from viral infection due to immune suppression was 5%, which is much lower than in prior studies.
Scientists Prove Bioengineered Uteri Support Pregnancy
In new research from the Wake Forest Institute for Regenerative Medicine (WFIRM), scientists have shown that bioengineered uteri supported fertilization, fetal development, and live birth with normal offspring. With further development, this approach may someday provide a regenerative medicine solution for women with the inability to get pregnant due to uterine dysfunctional infertility. Magalhaes et al showed that bioengineered uteri in an animal model developed the native tissue-like structures needed to support normal reproductive function. The strategy to bioengineer functional tissues using a patient’s own cells seeded onto biodegradable scaffolds has been effectively explored at WFIRM in preclinical studies and applied successfully in human patients to restore function in tubular and in hollow non-tubular organs. Regenerative medicine and tissue engineering technologies have emerged as an attractive option for overcoming donor organ shortages and other limitations of transplantation from donors. 

 
EVENTS, OPPORTUNITIES, RESOURCES
SARS-CoV-2 Research Grade Test Material Available For Feedback on its Utility for Assays
The National Institute of Standards and Technology (NIST) is providing a new material that can aid in the evaluation and development of diagnostic assays for SARS-CoV-2. This material consists of two synthetic RNA fragments from the SARS-CoV-2 genome that include the targets of many molecular diagnostic tests. The RNA fragments are characterized for concentration using digital PCR and can be used to assess the limits of detection for assays and to calibrate other in-house or commercial SARS-CoV-2 controls. Through funding from the Coronavirus Aid, Relief, and Economic Security (CARES) Act, NIST is making this material available free of charge to research institutions, testing laboratories and commercial vendors of assays/controls and requests feedback on its utility and suitability. Interested individuals are asked to complete this form. More information can be found on the NIST website
AABB Providing Discounted Resources for Early-Career Professionals 
AABB has developed packages of highly discounted resources that will allow trainees to continue learning remotely, following multiple requests from institutions for educational programs for their early-career professionals. Various programs have reported that their MT students, fellows, and residents have had to cut their rotations and/or learning short due to the COVID-19 crisis. AABB is providing these resources based on its commitment to cultivating a well-trained workforce, even in the face of adversity. 
AABB COVID-19 Resources Available
AABB has a Coronavirus Resources web page that provides the Association's latest information and tools related to coronavirus disease (COVID-19), including information from FDA, AABB and partner organizations related to cellular therapy products and COVID-19. AABB continues to monitor the COVID-19 situation closely and update the resource as new information becomes available.
NIH Launches Initiatives to Collect COVID-19 Data to Advance Treatments, Track Disease Spread
The National Institutes of Health (NIH) opened a centralized, secure system to store and study vast amounts of medical record data from people diagnosed with COVID-19 to advance therapies for and track spread of the disease. The program is part of an effort called the National COVID Cohort Collaborative (N3C), which seeks to help scientists analyze data to better understand COVID-19 and develop treatments. The N3C will include an analytics platform to systematically collect clinical, laboratory and diagnostic data from health care organizations nationwide. It will then harmonize the aggregated information into a standard format and make it available for researchers and health care providers. A demonstration of the platform is available online.
 
In addition, NIH's All of Us research program will leverage its participant base to seek new insights into COVID-19 through antibody testing, a survey on the pandemic's impacts and the collection of electronic health record information. Investigators will give approved researchers access to the data gathered through these activities. Analyses may help reveal the origins of entry, as well as the spread and impact of COVID-19 in the U.S. Additional information about the All of Us program is available online.
Video Illustrates How Face Coverings Help Slow Spread of COVID-19
Coverings_2_1632559.jpgHealth officials encourage the use of face masks to help slow the spread of COVID-19, and the CDC has published information about cloth face coverings on their website. To see how effective face masks can be in preventing the spread of virus, view these high-speed visualizations, produced by NIST, illustrating airflow when breathing and coughing using home-made masks. 
Emergency Use Authorizations Can Protect Against CBRN Threats
EUAs_2_1632548.jpgThe Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against chemical, biological, radiological and nuclear (CBRN) threats by facilitating the availability and use of medical counter measures (MCMs) needed during public health emergencies. Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved and available alternatives. 

Section 564 of the FD&C Act was amended by the Project Bioshield Act of 2004 and was further amended by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), the 21st Century Cures Act of 2016, and Public Law 115-92 of 2017. A brief overview is provided in a video produced by FDA.
Searchable Visual Guide to 3D Human Cells
The Allen Institute for Cell Science was established to better understand and predict cell behaviors. Current projects use live imaging of the major cell structures to acquire data that can be used to develop predictive and mechanistic models of how cells behave. Visit their website to view their 3D imaging.

 
FOR MEMBERS ONLY
CELLSOURCE_Globe(1).jpg
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 and stay in the loop of CT happenings. Selected materials presented on monthly calls can be found on the CCT projects’ website. Some of the recent highlights:

Asia Pacific Group: Presentations on Common CT Non-Conformances For Facilities in the Asia-Pacific Region by Frances Ivester, MNS, SI(ASCP), CQA(ASQ), lead assessor, AABB, and Stem Cell Tourism - An Overview by Indira Guleria, PhD, D(AHBI).

Cord Blood: Cord Blood: The Effect of the COVID-19 Pandemic on Cord Blood Banking presented by Donna Regan, MT(ASCP)SBB.

CT-CET: Case Study MSC for COVID Pneumonia presented by Alma-Reyes Calavera, MD, assistant professor, University of the East Philippines, The Medical City, and Biopreservation and Stability Optimization – Discussions Related to Covid-19 and Clinical Manufacturing Workflow presented by Aby J. Mathew, PhD.

QRM: Discussions on working remotely in the time of COVID-19, as well as NIH Initiatives to Collect COVID-19 Data to Advance Treatments and Track Disease Spread; Exosomes for Marketing Unapproved HCT/Ps; and Federal Register notices for CJD, HIV and malaria guidance documents.

SLS: SLS_2_1632543.jpgTechnologies to Increase Altruistic Blood Donation, was presented by César Humerto Esquivel Téllez, president of Blooders.org, and Methodologies for Bone Marrow Cryopreservation and Alternative Use of Cord Blood for Adult Transplants was presented by Federico Rodríguez Quezada, SBB. The leader of the subsection, Celina Montemayor, MD, PHD, participated in an interview to discuss AABB, standards, accreditation and the SLS. Her interview, conducted in Spanish, was posted to Facebook
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