Just the FACTs 2023 Volume 4
President’s Letter
FACT continues to ramp up efforts to globalize transplant and cellular therapy via education, inspector recruitment, and funding initiatives. We have continued our “world tour” of events these past couple of months in Minneapolis and Paris and we are looking forward to our next stops in Miami Beach, Houston, Puebla, and Perth. We have of course continued to hold events in “Virtual Land” to ensure access for all!! Bolstering the strength of our workforce is critical as demand for our services grows geographically and more cell and gene therapies/approaches are being commercialized. Therefore, please encourage and support the attendance of personnel at your programs to attend these educational opportunities and those offered by ASTCT and ISCT that are described in this newsletter.
This newsletter also lists two opportunities where we need your critical contributions and input. One such opportunity is to submit your feedback during the public comment period for the draft eighth edition of the NetCord-FACT Cord Blood Banking Standards. The other opportunity is the WBMT Global CAR-T and Cell Therapy survey to inform the World Health Organization (WHO). I thank you in advance for your engagement in the international cell therapy community.
Finally, the global nature of this newsletter is a fitting environment in which, on a sadder note, to mourn the loss of a dear friend and colleague, Ian K. McNiece, PhD. An Australian by birth, Ian was an internationally renowned leader within the cell therapy community and a strong force at FACT where he served as a Board member, an inspector, and as the Chair of the Regenerative Medicine Task Force, among his many other roles. Ian was also a beloved family member and friend as described by Dr. Richard J. Jones in a poignant article included in this newsletter. Please join me in sending Ian’s wife, Peggy, our sincerest condolences.
Sincerely,
Catherine M. Bollard, MD
FACT President
Comments Requested on Draft Eighth Edition NetCord-FACT Cord Blood Banking Standards
By Monique Summers, RN, MSN, MPA, FACT Standards Development Manager
FACT has published the draft eighth edition NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration for public comment through September 15, 2023.
These comprehensive Standards promote quality medical and laboratory practices throughout all phases of cord blood collection, processing, and banking to consistently achieve quality placental and umbilical cord blood units for administration and to improve patient outcomes. These Standards are applicable to both unrelated donor units and family units and cover 1) collection of cord blood cells, regardless of the methodology or site of collection; 2) screening, testing, and eligibility determination of the maternal and infant donor according to Applicable Law; 3) all phases of processing, cryopreservation, and storage; 4) testing and characterization of the cord blood unit; 5) making the cord blood unit available for administration, either directly or through listing with a search registry; 6) the search process for selection of specific cord blood units; 7) reservation and release of cord blood units for clinical use; 8) transport or shipment of fresh or cryopreserved cord blood units; and 9) clinical follow up. The final Standards will be published in December 2023.
The purpose of this public comment period is to receive your comments and suggestions on this edition of the Standards. The published draft is a redline document intended to highlight the significant changes. Some changes are new standards; however, others are intended to clarify rather than change the intent, or to provide consistency with other sets of FACT Standards. Minor reorganization and clarifications are not tracked.
Review the Draft Eighth Edition Cord Blood Standards
For instructions and to submit your comments(s), go to the Cord Blood Public Comments Survey.
FACT Encourages Completion of CAR-T and Cellular Therapy Worldwide Survey
The Worldwide Network for Blood & Marrow Transplantation (WBMT), in conjunction with assistance from the UT Health Science Center San Antonio, has initiated a CAR-T and Cellular Therapy survey. The purpose of the survey is to better understand the worldwide situation with regards to the availability of both commercially approved and investigational CAR-T therapy as well as other forms of advanced cell-based therapy (e.g., mesenchymal stromal cells). It will provide insight not only into the availability of these therapies worldwide but also of issues pertaining to accessibility, manufacturing capabilities, apheresis, accreditation, and presence of regulatory frameworks and legal oversight of these cell-based therapies.
This data gathering exercise will facilitate WBMT’s discussions with its affiliated partner, the World Health Organization (WHO), with the intention of trying to achieve equity of access to life saving cell-based treatments, especially CAR-T, worldwide. It will also help WHO in understanding the landscape of cell therapy across different regions in terms of the crucial scientific, clinical, and regulatory components needed to achieve equity of access.
This is an entirely fact-finding survey, and all results will be handled with strict confidentiality. Individual data and responses will only be accessed by the primary investigators for this survey. All results will be presented by region/country rather than by institutions. This survey is to be filled by the program director or a designee and each institution should only be represented once. Do feel free to write more in the free-flowing text area, and for those who are unable to fill every field/question, we would also like to receive your reply. It is also important to receive survey replies from those who do not have any form of cell therapy in their hospital/centre/institution.
Participation in this survey is completely voluntary. Nonetheless, we would strongly encourage participation as we expect this survey to generate important data which could lead to further important initiatives, especially with WHO.
For any further questions, inquiries, or issues with the survey, please contact:
Mickey Koh, MD
Hildegard Greinix, MD
Mahmoud Aljurf, MD
Fazal Hussain, MD
at mail@wbmt.org or mickey.koh@stgeorges.nhs.uk
This survey should take less than 15 minutes to complete. To ensure easy access to the survey, please follow these steps:
- Take this survey from a laptop, and not from a phone or other type of device.
- Make sure you are connected to a secure and steady Wi-Fi network.
- Copy and paste the link to the survey in an incognito/private browser. You can open the incognito mode as follows: on your keyboard, please press Ctrl, Shift, N simultaneously (for Apple users the correct combination is Command, Shift, N). Once the incognito page has opened up, you can copy and paste the link in the field and start the survey.
Link to survey: https://uthscsa.co1.qualtrics.com/jfe/form/SV_0plkcuqDW3bSpOC
Please submit your survey responses by August 31, 2023.
Establishing a New Collection or Processing Facility at a FACT-Accredited Clinical Program
By Sarah Litel-Smith, BSMT (ASCP), FACT Accreditation Services Supervisor
FACT-accredited Clinical Programs are required to use Collection and Processing Facilities that meet FACT Standards with respect to their interactions with the program. A program with an opportunity to establish its own collection and/or processing facilities must ensure continued compliance with the Standards, including during the transition of operations to the new facility. As outlined in the Maintaining Accreditation Policy available on the FACT website, the accredited program will need to continue to use the currently accredited facility until the new facility is accredited or has demonstrated compliance with the FACT Standards.
A new Collection or Processing Facility is required to be established, in operation for 12 months, and perform the minimum number of procedures prior to accreditation. The application for accreditation can precede the 12 months of operation, provided key personnel, processes, validations, and documented staff training are in place for at least nine months before inspection.
The Clinical Program must notify FACT of the intention to use a new Collection or Processing Facility prior to its use and develop a transition plan. FACT will review the proposed transition plan to determine an appropriate percentage of patient products the new facility may collect or process for the program prior to achieving FACT accreditation.
The proposed transition plan should address the following, as well as each category outlined in the table below:
- Identification of key personnel, including a description of qualifications, relevant experience, education and training, and number of personnel.
- A description of the number and types of cellular therapy products to be collected or processed.
- A description of facility location, layout, and equipment.
- A description of the Quality Management Plan, completed qualifications, validations performed, and written policies and Standard Operating Procedures describing collection or processing processes.
- A plan to perform an initial assessment of three collected or processed patient products for yield and viability in comparison to products collected or processed by the currently accredited facility, and the plan to reassess patient products at pre-determined intervals.
- Assurance that the Clinical Program will continue to use the currently accredited collection or processing facility until the new facility is accredited or has demonstrated compliance with the FACT Standards.
- Timeline for the new facility becoming FACT accredited, and when FACT can expect progress reports regarding the transition.
TABLE: Steps for Establishing a New Collection or Processing Facility
| Step | Category | Action | Standards |
| 1 | Facilities | Identify the location of the Collection or Processing Facility, layout, and equipment. Ensure facilities include appropriate designated areas for activities, are of adequate size, and are suitable for the activities to be performed. | C2, D2 |
| 2 | Personnel | Hire key personnel. Ensure the Facility Director, Facility Medical Director, Quality Manager, and a minimum of one additional designated staff member are appropriately trained, qualified, and experienced. | C3, D3 |
| 3 | Equipment | Acquire required equipment and complete critical qualifications. | C8.2, D6.4 |
| 4 | Policies and Standard Operating Procedures: | Develop collection or processing Standard Operating Procedures. | C4, C5, D4, D5 |
| 5 | Quality Management | Create a Quality Management Plan and document control system. | C4, C5, D4, D5 |
| 6 | Validations | Perform an initial assessment of three collected or processed donor products for sterility, yield, and viability in comparison to products collected or processed by the currently accredited facility. | C4.14, D4.14 |
| The date of facility establishment is the date the first validation run is performed or later. | |||
| 7 | Notify FACT | Notify FACT of intention to add new Collection or Processing facility, and progress to date. | |
| 8 | Register | Register with the appropriate authorities. Register with ICCBBA, and implement and validate ISBT 128-compliant labels. | C1, D1
C7.4, D7.4 |
| 9 | Transition Plan | Submit a transition plan to FACT for review prior to collecting or processing patient products for administration at the new facility. The Clinical Program must continue to use the currently accredited facility until the new facility is accredited or has demonstrated compliance with the FACT Standards. | |
| FACT will review the plan and, if appropriate, approve a quantity of patient products to collect or process sufficient to maintain competency. The majority of products will be collected or processed at the accredited facility until the new facility is accredited or meets accreditation requirements | |||
| When multiple collections are planned, it is advisable to have one product collected or processed at the currently accredited facility and one at the new facility to compare engraftment, product dose, viability, and sterility results of each facility. If this is not possible, we recommend collecting or processing patients in cohorts of no more than three and evaluating engraftment, product dose, viability, and sterility of each cohort before starting another cohort. | |||
| 10 | Eligibility or Add-On Application | The new facility can begin an Eligibility or add-on application six months after establishment by submitting the request and an update on progress and completed Facility Grid. | |
| A new collection or processing facility is required to be established, in operation for 12 months, and perform the minimum number of procedures prior to accreditation. The application can precede the 12 months, but key personnel, processes, validations, and documented staff training in the collection or processing procedure(s) must be in place for a minimum of nine months before inspection. |
Register for the 2023 AcCELLerate Forum: Join in Person or Virtually
ASTCT™, CIBMTR® and the National Marrow Donor Program®(NMDP)/Be The Match® are excited to announce that registration is now open for the 2023 AcCELLerate Forum!
Participate in person or virtually in impactful conversations regarding patient needs, therapies, and access to cell and gene therapy with advocates, industry representatives, researchers, and providers. Together we will identify needs and opportunities in the field for advocacy and sustainability.
Preliminary agenda topics include:
- 80/20 Updates
- Access and Care Disparities in Cellular Therapy
- Cost-Mitigating Approaches in Cellular Therapy
- Future Directions in Cellular Therapy
- Histocompatibility Impact on Safety and Efficacy
- Logistics for Cell Therapy Delivery in Different Settings
- Point-of-Care Manufacturing and Production
- Regulatory Process for Approving New Products
View the up-to-date agenda (subject to change)
Follow #accellerate23 for updates
ISCT Initiatives Address both Workforce Challenges and Regulatory Knowledge
ISCT has announced the following initiatives related to workforce development and regulations. Follow the links for more information and take advantage of these opportunities!
- Cell and Gene Therapy Global Regulatory Report: The first biannual global regulatory report from ISCT and Citeline includes a global overview of the cell and gene therapy landscape, regulatory events, and key legislative/framework changes and international standards.
- In-person Technologist Training Course at the ISCT NA 2023 Regional Meeting in Houston: This course is designed by experts to provide essential skills and knowledge for CGT manufacturing. The one-day interactive course on September 10 in Houston at the North America Regional Meeting will cover essential topics such as collections, QC/QA, regulatory, distribution logistics, and devices, and will provide insights into working with industry partners.
- ISCT Workforce Development in Biomanufacturing Advanced Hands-On Training Course: This five-day, hands-on training teaches you the techniques central to cell and gene therapy manufacturing, including aseptic cell culture techniques, large-scale cell manufacturing, analytical techniques and product characterization, cell banking and documentation using GLP/GMP-like best practices. It will take place August 7 – 11, 2023 at Georgia Institute of Technology in Atlanta.
- 2023 Global Workforce Development Survey: The 2023 survey aims to collect information about historic and recurring training opportunities pursued by respondents, as well as information about current roles and responsibilities. The survey also aims to gather insights into the current state of the CGT field in order for ISCT to identify gaps in training and education to develop strategies to address them effectively. The survey should take approximately 10 minutes, and results will be publicly available in a report published by ISCT once data has been analyzed. All participant data will be anonymized. The survey closes August 8, 2023.
Current Quality Management Webinar Series on Embracing Change: Growing Your Cellular Therapy Services
The theme for Series 12 of FACT Quality Management Webinars is embracing change. Each webinar will equip organizations with practical strategies and insights to successfully incorporate a new service or product into your cellular therapy organization while ensuring compliance, optimizing patient outcomes, and driving continuous improvement.
There will be two parts for this series. Part I of the series in 2023 includes the following webinars:
- July 13 – Facility Needs Assessment & Change Control (recording)
- September 27 – Establishing Quality Indicators
- November 14 – Written Agreements
- TBD – The cellular therapy organization’s perspective on these topics
Registration is available for each webinar individually using the links above, or bundle and save 15% on the full series! The bundle can be purchased at QM Series 12 Webinar Bundle.
Upcoming FACT Educational Events
FACT Clinical, Collection, Processing, & Cord Blood Banking Inspector Training Course
Perth, Australia, August 15, 2023
8:00 am – 5:00 pm AWST
FACT Accreditation and Quality Principles Workshop
Perth, Australia, August 15, 2023
8:00 am – 5:00 pm AWST
FACT Cellular Therapy Accreditation Workshop
Puebla, Mexico, August 24, 2023
8:00 am – 12:00 pm CT
FACT Processing Inspector Training Course
Houston, TX, September 7, 2023
8:00 am – 5:00 pm CT
FACT Cord Blood Bank Accreditation Workshop
Miami, FL, September 7, 2023
8:00 am – 5:00 pm ET
FACT Cord Blood Inspector Training Course
Miami, FL, September 7, 2023
8:00 am – 5:00 pm ET
FACT Accreditation Portal 2.0 Open House – Session 1
Miami, FL, September 8, 2023
7:15 am – 8:00 am ET
FACT Accreditation Portal 2.0 Open House – Session 2
Miami, FL, September 8, 2023
7:15 am – 8:00 am ET
FACT QM Series 12 Webinar: Establishing Quality Indicators
September 27, 2023
10:00 am – 11:00 am CT
FACT QM Series 12 Webinar: Written Agreements
November 14, 2023
10:00 am – 11:00 am CT
