DUE JUNE 30, 2022: Standards Coordinating Body Seeks Comments on Chain of Identity Identifier Definitions and Requirements
The Standards Coordinating Body (SCB) assembled a multi-stakeholder working group, including FACT, to develop proposed definitions and requirements for Chain of Identity (COI) identifiers titled, “Key Requirements and Definitions for Chain of Identity Identifier.” Standard definitions and requirements have become increasingly important as the number of players in the cellular therapy supply chain has increased and become more diverse. FACT strongly recommends its accredited organizations and inspectors review the draft and submit comments. Comments are due by June 30, 2022.
As SCB explains in the draft, COI identifiers are essential to demonstrating adequate control of biological material. FACT-accredited organizations have expressed concern about the challenges of implementing several identification systems at a single institution and how they pose risks of mix-ups. These definitions will hopefully lead to consistent use of COI identifiers and potentially allow the development of common COI identification systems for multiple cellular therapy products.
Please review the draft and submit your comments via the commenting template to Dawn Henke at firstname.lastname@example.org.
FACT participates in several working groups of the Standards Coordinating Body (SCB), including the Cell Collection Standards for Cell and Gene Therapies group. The SCB website introduces this group as follows: “Because other advanced fields with similar biological products (e.g., bone marrow and apheresis) have established collection best practices, the regenerative medicine community is eager to leverage those practices to create an international collection process standard that will help ensure the consistency of the critical quality attributes of cells collected for regenerative medicine products.”
With interest and participation from industry and the United States Food and Drug Administration (FDA), the efforts of this group may impact FACT-accredited Apheresis Collection Facilities and we strongly encourage participation of apheresis professionals given their direct experience and expertise in cell collection.
Through the work of this group, SCB has successfully obtained agreement from the Parenteral Drug Association (PDA) to draft standards on cell collection. Although industry is the intended audience for these standards, requirements may be promulgated through the requirements that clinical trial sponsors and commercial manufacturers expect of apheresis collection sites in their networks.
The PDA is recruiting volunteers to draft the requirements, currently referred to as “Apheresis Collection for Cell and Gene Therapy Products,” until July 16, 2021. “The goal is to create a standard document outlining recommendations for product manufacturer/sponsor requirements for apheresis cell collection. It will also create a standardized template for the leukapheresis manuals/SOPs written by product manufacturers/sponsors for the apheresis centers. This combined effort will work to reduce the burden upon the collection centers and in doing so, reduce errors.”
FACT encourages participation from accredited Apheresis Collection Facilities. According to the PDA, volunteers must have some subject matter expertise, and be willing to help write/contribute to this standard. Applicants should apply by contacting the PDA Standards Manager at email@example.com.
Apply to the PDA technical team for this standard by July 16, 2021!
To Our Colleagues in Industry:
The SCB is asking industry groups and manufacturers to share their apheresis collection requirements and guidance to help with the creation of the new Parenteral Drug Association (PDA) standard effort, PDA 08-202x: Apheresis Collection for Cell and Gene Therapy Products.
For this effort to be successful, the PDA working group will need a clear view of what industry groups and manufacturers currently require, so that it can fit the standard as close to common industry practices as possible. To gain that insight, please fill out this short survey. The data collected will only be viewed/used in aggregate and will not be used outside of the standards effort. Please fill out this survey at your earliest convenience.
The Standards Coordinating Body (SCB) is seeking input from the regenerative medicine community to update its report: Community Perspectives: Needed Standards in Regenerative Medicine. The content and potential impact of this report on the development of future standards may impact FACT stakeholders, and we encourage volunteer inspectors and personnel from accredited organizations to complete the survey. The survey will be available until November 6, 2020 at 12 pm Eastern Standard Time.
Per the SCB, this report, “is intended to align community efforts around the standards that could have the greatest benefit to the regenerative medicine field and improve the safety and quality of regenerative medicine products. Your input will ensure that the report reflects the current needs and perspectives of stakeholders in the community, helping to direct time and resources toward the highest-priority standards.”
The following message is sent on behalf of the Standards Coordinating Body for Regenerative Medicine.
As the fields of cell and gene therapies grow, so may the burdens on both apheresis cell collection centers and industry. Standardization of some common collection parameters may reduce this burden on both. Improved consistency and standardization would also improve product quality and potentially improve patient outcomes while reducing errors and audit fatigue.
The Standards Coordinating Body has convened a working group of experts from industry, apheresis cell collection centers, processing laboratories, accreditation bodies, research centers, and other stakeholders to work towards these goals.
We’ve developed two surveys to assess current practices, which take approximately 20 minutes to complete:
For Industry: https://cell-collection-for-industry.questionpro.com
For Apheresis/Cell Collection Centers: https://apheresis-center-survey.questionpro.com
On behalf of the subject matter experts who drafted this survey, and the Standards Coordinating Body, thank you for your time and your essential contribution to this standard development initiative.
Comments Requested on Standard Labeling Proposed for Apheresis Collection Products: Due April 24, 2020
FACT is pleased to announce that ICCBBA, administrator of the ISBT 128 coding and labeling standard, has released a draft document and label for public review and comment. The document, “Standard Labeling for Apheresis Collection Products for Sponsor Cellular Therapy Manufacturing,” and the described label applies to collected cells, commonly referred to as “starting material,” intended for further manufacturing in support of clinical cellular therapy trials and commercial cell products. This draft is a result of a multi-stakeholder effort to standardize labeling requirements of apheresis collection facilities, including the Standards Coordinating Body, the Deloitte NextGen Industry Working Group, FACT, and many others.
Variations in sponsors’ labeling requirements have been a notable challenge for apheresis facilities in recent years and introduce risks of errors and misinterpretation of patient data. The use of an ISBT 128-compliant label will reduce manual transcription errors and promote chain of identity, including for autologous cells. Furthermore, the use of ISBT 128 for these collections will allow the use of processes, labels, equipment, and software compatible with those already in use for other types of cellular therapy products collected by apheresis facilities for clinical application.
The next step of this important standardization effort is to solicit input from the entire community. Please review this document and provide comments by April 24, 2020 to Dawn Henke of the Standards Coordinating Body (firstname.lastname@example.org). Equally important, please distribute this announcement to your industry, hospital, vendor, and professional colleagues to make them aware of this opportunity and encourage them to review the document and submit feedback.
The Standards Coordinating Body (SCB) and Nexight are requesting comments on a report titled, Community Perspectives: Needed Standards in Regenerative Medicine. The report outlines prioritized areas in cell therapy, gene therapy, and tissue engineering. Comments are due by June 19, 2019.
Per the SCB website, “One of SCB’s goals since its inception has been to strengthen the identification and prioritization process for advancing regenerative medicine standards through greater community engagement, a goal we outlined in Realizing the Promise of Regenerative Medicine Therapies: Strengthening the Standards Development Process. The methodology we used to create the report on needed standards allowed us to implement many of these process improvements.”
This report was drafted under contract for the United States Food and Drug Administration (FDA) and has the potential to be influential in the direction the cellular therapy field takes toward standardization. Your comments as experienced professionals are critical to charting the path.
Send comments to Sarah Lichtner at email@example.com by June 19.
The Standards Coordinating Body (SCB) was formed as an answer to the Advancing Standards in Regenerative Medicine Act, and holds contracts with the Food and Drug Administration (FDA) to advise the agency on needed standards in regenerative medicine. It formally supports many standards development efforts in conjunction with other organizations. FACT is an engaged member organization and participates in SCB projects and provides regular feedback as requested by the SCB.
Did you know that the transplant and cord blood banking communities are critical to the SCB’s efforts?
Although “regenerative medicine” is a very broad term with connotations related to “new” or “novel” therapies, many of the SCB’s projects relate to issues in which FACT-accredited organizations have decades of experience. Accredited organizations are often the facilities that collect cellular starting material, perform contract manufacturing or supportive processing and cryopreservation procedures, or clinically support specialties not yet experienced in cell and gene therapies. Even those organizations that are not directly involved have had to evaluate, resolve, and manage solutions to the very challenges newer players in cell and gene therapies are struggling with now.
Please share your experiences and expertise with the Standards Coordinating Body!
Your input will assist the SCB with its mission, inform commercial manufacturers and other specialties on inherent differences in cell and gene therapies, and promote solutions that harmonize with existing Standards and regulations. The SCB’s outputs could directly impact your daily work and, more importantly, help expedite availability of therapies to patients sooner rather than later. Express your interest in participating in SCB projects to Dawn Henke, SCB Senior Technical Program Manager, at firstname.lastname@example.org.
The following are notable SCB initiatives that are likely of interest to many FACT-accredited organizations. There are many more that may be intriguing based on professional interests. For a full listing of projects and reports, visit the SCB’s website at https://www.standardscoordinatingbody.org.
- Cell Collection Standards for Cell Therapies: FACT, SCB, commercial manufacturers, and many other organizations have heard, loud and clear, that apheresis facilities are struggling with the increasing volume of effort required of variable collection and audit requirements. This project group is currently formulating surveys to distribute to industry and apheresis facilities to learn what needs could be reconciled and then standardized.
- Cryopreservation of Cells (PDA-led project): Many commercial manufacturers have sought best practices related to cryopreservation and have had to adjust those practices to fit the needs of their particular cellular therapy products. This project group is drafting a framework on which to establish cryopreservation procedures in the hope to standardize requirements when possible.
- Transportation Requirements of Cells for Therapeutic Use: Shipping and transportation have a direct and significant influence on chain of custody and chain of identify of cellular therapy products, and is of great interest to commercial manufacturers. This project group is working to identify gaps in current Standards. Due to the emphasis on shipping and transportation requirements in FACT Standards, efforts to remain harmonization with these existing Standards will prevent conflicting requirements.
- Community Perspectives: Needed Standards in Regenerative Medicine Report: This report, based on input from many stakeholders, outlines needed standards that could have the greatest benefit to the safety and quality of regenerative medicine products. The draft is currently available, and will be updated as needed based on comments the SCB received during its recent public comment period in May 2019.
By Andra Moehring, FACT Standards Development Manager
Congratulations to Dr. Paul Eldridge, FACT Standards Chair, and the FACT Common Standards Steering Committee on publishing the Second Edition FACT Common Standards for Cellular Therapies on March 15, 2019. The Standards will become effective on June 15, 2019.
The Second Edition FACT Common Standards Steering Committee is comprised of 12 representatives who worked for 23 months on the development of the Standards. The committee’s commitment, expertise, and experience is invaluable to the development of these Standards.
The Standards contain important additions and changes to requirements to reflect current processes typical in a cellular therapy program. These changes maintain the relevance of the Standards in the field of cellular therapy.
Public Comment Period
During the 60-day public comment period, 240 comments were submitted by 19 contributors. The committee was responsive to public comments and requests made on behalf of related organizations.
FACT greatly appreciates contributors taking the time to review the draft Standards and submit comments.
Accessing the Standards and Other Resources
The Standards, summary of changes, and crosswalks are available on the FACT website at http://www.factwebsite.org or by using the links provided below:
FACT Common Standards, Second Edition
Purchase Printed Copies
Summary of Changes to FACT Common Standards, Second Edition
FACT Common Standards Crosswalk First to Second Edition
FACT Common Standards Crosswalk Second to First Edition
If you have questions related to the Second Edition FACT Common Standards, contact your FACT Coordinator or submit your questions to email@example.com.
Thank you for all of your contributions!
By Andra Moehring, FACT Standards Development Manager
The draft Seventh Edition NetCord-FACT Cord Blood Standards and accompanying Accreditation Manual were published for public review and comment for a 90-day period on November 30, 2018. To ensure that members of the cord blood community have reviewed the proposed significant changes in the draft Standards, and have had an opportunity to provide their input, the comment period is extended for an additional 30 days. Comments will now be accepted through April 1, 2019. Links are provided below to the draft Standards, Accreditation Manual, and comment form.
These Standards apply to all phases of cord blood collection, banking, and release for administration, including donor management, collection, processing, testing, cryopreservation, storage, listing, search, selection, reservation, release, and distribution to clinical programs.
Comments on any aspect of the draft are welcome. However, members of the cord blood community are strongly encouraged to specifically review and provide comment on three significant changes proposed in the draft Seventh Edition:
- ISBT 128 and Eurocode Coding and Labeling (B6.1.2, Appendix II)
- Supplies and Reagents of the Appropriate Grade (B8.4.1)
- Viability of CD45 Testing and Specification Requirements (Appendix IV, Appendix V)
Comments regarding the draft Seventh Edition NetCord-FACT Cord Blood Standards can be submitted by accessing the Comment Form.
Comments will be accepted through April 1, 2019.
For questions or assistance, please contact Andra Moehring.
Publication of the FACT-JACIE International Standards for Hematopoietic Cellular Therapy, Seventh Edition
By Andra Moehring, FACT Standards Development Specialist
Congratulations to Dr. Paul Eldridge, FACT Standards Chair, and the FACT-JACIE Standards Committee on publishing the seventh edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration on March 1, 2018. The Standards will become effective on May 30, 2018.
The Foundation for the Accreditation of Cellular Therapy (FACT) has several committees to help FACT achieve its vision of being the premier organization setting standards and awarding accreditation to programs in the evolving field of cellular therapy.
The seventh edition FACT-JACIE Standards Committee is comprised of 58 representatives from around the world who worked for 23 months on the development of the Standards. The committee is divided into four subcommittees: Clinical, Collection, Processing, and Quality Management. The FACT Immune Effector Cell (IEC) Task Force was also involved in the development and review of IEC specific requirements. Everyone’s commitment, expertise, and experience is invaluable to these Standards.
The seventh edition of the Standards contains important additions and changes to requirements to reflect current processes typical in a cellular therapy program. These changes maintain the relevance of the Standards in the field of cellular therapy.
Public Comment Period
During the 90-day public comment period, 653 comments were submitted by 78 contributors residing in 12 different countries. The committee was responsive to public comments and requests made on behalf of related organizations to ensure the seventh edition is broadly accepted throughout the cellular therapy community.
FACT and JACIE greatly appreciate contributors taking the time to review the draft Standards and submit comments.
Accessing the Standards and Other Resources
The Standards, accompanying Accreditation Manual, summary of changes, and crosswalks are available on the FACT website at http://www.factwebsite.org or by using the links provided below:
Dr. Eldridge presented a webinar on how to “Effectively Transition to the 7th Edition Hematopoietic Cellular Therapy Standards” on March 14, 2018. Based on the questions received, a question and answer document was created to assist those who were unable to attend. If you were unable to attend the webinar, you can purchase the recording. FACT inspectors may download the recording for free!
If you have questions related to the seventh edition FACT-JACIE Standards, contact your FACT Coordinator or submit your question to firstname.lastname@example.org.
Thank you for all of your contributions!
The 20th year of FACT successfully built upon its history of successes to advance cellular therapy and regenerative medicine. As physicians and scientists continue to make advancements, opportunities arise for FACT to play a supporting role to educate all programs on new approaches and therapies. The following are highlights from 2016:
1. FACT Celebrates 20th Anniversary
FACT celebrated its 20th year as the leading organization in standards setting and accreditation for cellular therapy, hematopoietic stem cell transplantation, and regenerative medicine. FACT welcomed visitors to a dynamic exhibit booth at the BMT Tandem Meetings and the ISCT Annual Meeting to celebrate with the organization. Attendees who wore their commemorative FACT 20th anniversary pin received gifts and were entered in a daily drawing for prizes.
FACT also hosted anniversary receptions at these meetings, and many FACT colleagues, volunteers, and friends enjoyed hors d’oeuvres and refreshments as FACT celebrated two decades of working together in the community to improve patient care and safety. Guests enjoyed watching a short video highlighting FACT’s past 20 years, and saw some familiar faces who have been an integral part of FACT since its beginning.
2. FACT Commences Review of Corrective Action Plans for Low One-Year Survival
The FACT Clinical Outcomes Improvement Committee began formally reviewing corrective action plans submitted by Clinical Programs that did not meet expected one-year survival as outlined by comparative data. The emphasis of the committee is to help programs identify ways to improve their outcomes for patients. After several months of reviewing corrective action plans, the committee has articulated its expectations for these plans using six guidelines:
- The corrective action plan must identify specific causes of death.
- The corrective action plan must provide quantitative data.
- The assessment must identify reasonable causes of the low one-year survival rate.
- The corrective action plan must address the identified causes.
- There must be a measurable outcome improvement.
- The program must provide updates on corrective actions at the time of inspection, at the time of annual reporting, or as otherwise directed by the committee.
3. FACT Presents Comments at FDA Hearing
The Food and Drug Administration (FDA) hearing to obtain comments on the four draft guidance documents relating to the regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps) occurred on September 12-13, 2016. Dr. Phyllis Warkentin spoke on behalf of FACT and presented the following comments to the FDA:
- FDA should fulfill its responsibilities to protect patients in search of cellular therapies. FACT supports its parent society, the International Society for Cellular Therapy (ISCT), in its position on unproven therapies and agrees on the importance of providing adequate education for patients. Development of professional standards and voluntary accreditation can play an important role in providing a bridge from basic research to clinical application.
- The tiered unified approach to HCT/P regulation fails to acknowledge the complexity of some tissues with multiple native functions and many cell types. It is difficult to strictly categorize complex tissues such as adipose tissue as only structural or cellular. Dr. Warkentin offered solutions for applying regulations to such tissues.
- There appear to be some inconsistencies in the definitions and examples of homologous use that would benefit from clarification.
- FACT suggests that the Agency expand upon its expectation for cord tissue, to include which regulations apply and when they apply, based upon the processes in place.
- International harmonization is important to facilitate product development and world-wide availability of cell-based therapies for patients.
4. Sixth Edition NetCord-FACT Cord Blood Standards Published
NetCord and FACT published the 6th edition NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration and its accompanying Accreditation Manual on July 1, 2016. These Standards became effective after 90 days, and all accredited cord blood banks were required to comply with the requirements by that time.
These Standards 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, including quarantine, testing, and characterization of the cord blood unit; 4) making the cord blood unit available for administration, either directly or through listing with a search registry; 5) the search process for selection of specific cord blood units; 6) reservation and release of cord blood units for clinical use; and 7) all transport or shipment of cord blood units, whether fresh or cryopreserved.
5. Draft 1st Edition Immune Effector Cell Standards Published for Public Comment
FACT published a draft of the 1st edition FACT Standards for Immune Effector Cells for inspection and public comment in July 2016. Interim standards for the 6th edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration were also proposed to include immune effector cell programs within blood and marrow transplant units. These Standards are intended to promote quality in administration of immune effector cells and will be incorporated into a voluntary FACT accreditation in this field.
The Standards apply to immune effector cells used to modulate an immune response for therapeutic intent, such as dendritic cells, natural killer cells, T cells, and B cells. This includes chimeric antigen receptor T cells (CAR-T cells) and therapeutic vaccines.
Commenters included, among others, pharmaceutical companies, the FDA, the American Society of Cell & Gene Therapy (ASGCT), and the Society for Immunotherapy of Cancer (SITC). A total of 131 comments were received, and reviewers generally expressed support for the Standards and posed worthy questions to consider.
6. CYCORD is First Cord Blood Bank in Cyprus to Earn FACT Accreditation
CYCORD Public Allogeneic Cord Blood Bank in Cyprus received internationally recognized FACT accreditation. CYCORD, directed by Paul Costeas, PhD, is the first and only cord blood bank in Cyprus to be recognized by FACT. The bank received accreditation on June 13, 2016, and is accredited for banking cord blood for both public and private family use.
7. Universidad Autónoma de Nuevo León, Servicio de Hematología Hospital Universitario is First Cellular Therapy Program in Mexico to Earn FACT Accreditation
Universidad Autónoma de Nuevo León, Servicio de Hematología Hospital Universitario in Mexico received internationally recognized FACT accreditation. Universidad Autónoma de Nuevo León, Servicio de Hematología Hospital Universitario, directed by David Gomez-Almaguer, MD, is the first and only cellular therapy program in Mexico to be recognized by FACT. The program received accreditation on September 6, 2016, and is accredited for Adult and Pediatric Allogeneic and Autologous Hematopoietic Progenitor Cell Transplantation, Peripheral Blood Cellular Therapy Product Collection, and Cellular Therapy Product Processing.
8. StemCyte India Therapeutics is First Cord Blood Bank in India to Earn FACT Accreditation
StemCyte India Therapeutics Cord Blood Bank, directed by Bhavin Kapadiya, MD, is the first and only cord blood bank in India to be recognized by FACT. The bank received accreditation on December 21, 2016, and is accredited for banking cord blood for both public and private family use.
9. FACT Hosts Quality Initiatives with Parent Organizations
FACT hosted a Quality Boot Camp at the annual meeting of the American Society for Blood and Marrow Transplantation (ASBMT). The goal of the boot camp program is to strengthen quality assurance activities through pre-meeting exercises and an in-person workshop. Members of the FACT Quality Committee encouraged registrants in the months leading to the in-person workshop to review specific aspects of their quality programs. Quality experts then presented important concepts and led roundtables that allowed participants to ask questions and help each other reach their goals during the boot camp. FACT also partnered with ISCT at their regional meeting to co-host sessions in the Quality and Operations Track. Presentations focused on outcome analysis from the processing perspective and the anatomy of an audit.
10. New Webinar Collaboration Between ASHI and FACT
FACT and the American Society for Histocompatibility (ASHI) began collaborating to offer webinars on transplant immunology. Establishing best practices in transplant immunology in different parts of the world requires both deep understanding of the unique challenges that face different parts of the world, and building on the experiences of well-established labs and international histocompatibility professional societies.
11. FACT Joins Standards Coordinating Body as a Charter Member
The Advancing Standards in Regenerative Medicine Act directs the Secretary of the United States Health and Human Services Agency to establish a public-private Standards Coordinating Body in Regenerative Medicine and Advanced Therapies. The Standards Coordinating Body (SCB) includes membership of the entire cross-section of regenerative medicine stakeholders. FACT was pleased to join as a charter member, and will organize its efforts as part of a consortium of non-government stakeholders that seeks to partner with one or more government organizations and regulatory agencies to coordinate consensus standards development efforts. More specifically, the SCB seeks to enable more efficient and successful clinical and commercial development of cellular/gene and regenerative medicine therapies through coordinating and prioritizing development of national/international standards for measurement assurance (among other objectives).
The Advancing Standards in Regenerative Medicine Act directs the Secretary of the United States Health and Human Services Agency to establish a public-private Standards Coordinating Body in Regenerative Medicine and Advanced Therapies. The function of the body is defined as (1) identify opportunities for the development of laboratory regulatory science research and documentary standards that the Secretary determines would support the development, evaluation, and review of regenerative medicine products; and (2) work with such Standards Coordinating Body, as appropriate, in the development of standards described in paragraph (1).
The Standards Coordinating Body (SCB) includes membership of the entire cross-section of regenerative medicine stakeholders. FACT was pleased to join as a charter member, and will organize its efforts as part of a consortium of non-government stakeholders that seeks to partner with one or more government organizations and regulatory agencies to coordinate consensus standards development efforts. More specifically, the SCB seeks to enable more efficient and successful clinical and commercial development of cellular/gene and regenerative medicine therapies through coordinating and prioritizing development of national/international standards for measurement assurance (among other objectives).
As the SCB is formalized in the coming months, FACT will announce milestones and initiatives to its stakeholders.