ISBT 128 Labeling Standard for Cells Collected for Cellular Therapy Manufacturing: Comments Due October 18th
Thanks to the teamwork of several stakeholders in apheresis cell collection, the field is one step closer toward label standardization. Comments are needed in the most recent draft ISBT 128 label published by ICCBBA by October 18, 2020.
As reported in previous Just the FACTs newsletters, a multi-stakeholder working group led by the Standards Coordinating Body and the Deloitte NextGen Industry Working Group, consisting of industry, registries, accrediting organizations, technology providers, and apheresis and quality subject matter experts, released a draft standard labeling proposal for collected cells.
Public comments following the release of that draft indicated support for ISBT 128 labeling for starting material intended for further manufacturing. After reviewing these comments, ICCBBA has released a draft Standard for Labeling of Collection Products for Cellular Therapy Manufacturing.
This Standard builds on existing ISBT 128 standards, including compatible label dimensions and essential traceability information, but also accommodates sponsor/manufacturer information. As stated by the ICCBBA website, “it is for use only in situations where the sponsor/manufacturer has adopted this standard and has provided the necessary information to populate the sponsor/manufacturer section of the label.” Although the standard was written with apheresis in mind, the label could be used on products collected from other sources and intended for further manufacturing.
In response to recent requests from blood transfusion services, ICCBBA has fast-tracked the release of new product description codes for COVID-19 Convalescent Plasma. The new codes can be found in the latest release of ISBT 128 Standard Product Description Code Database available at the ICCBBA website,. Inquiries and new PDC requests can be sent to email@example.com.
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 FACT Education Committee and Immune Effector Cell Task Force have developed a series of webinars on Immune Effector Cellular Therapy. Six webinars are planned throughout 2020 and include the following topics:
The State of FACT Immune Effector Cell Therapy Accreditation Today presented by Dr. Patrick Hanley
Wednesday, March 4, 2020
11:00 am ET, 16:00 GMT
Dr. Patrick Hanley, Director of GMP for Immunotherapy at Children’s National Health System Blood and Marrow Transplant Program, will present the State of FACT Immune Effector Cell Therapy Accreditation Today. Dr. Hanley will discuss the growth and expected direction of IEC Accreditation and describe the major concepts addressed the FACT IEC Standards. He will also explain various methods of compliance, as well as compare requirements between FACT and commercial manufacturers.
Labeling and Chain of Custody for IEC Products presented by Dr. Sarah Nikiforow
Wednesday, April 22, 2020
11:00 am ET, 15:00 GMT
Dr. Sarah Nikiforow from Dana-Farber Cancer Institute / Cell Manipulation Core Facility, will present Labeling and Chain of Identity and Custody for IEC Products. Dr. Nikiforow will review the IEC Standards related to labeling and chain of identity and custody and explain FACT expectations for clinical trial research product labeling and chain of custody from bench to bedside. In addition, she will describe how ISBT 128 coding and labeling can be used with commercial cellular therapy products.
Integration of Immune Effector Cellular Therapy into a FACT-Accredited Transplant Program presented by Dr. Carlos Bachier
June 17, 2020
11:00 am ET, 15:00 GMT
Dr. Carlos Bachier, Program Director and Processing Facility Director at Sarah Cannon Blood and Marrow Transplant Program in Nashville, will present Integration of Immune Effector Cellular Therapy into a FACT-Accredited Transplant Program. Dr. Bachier will begin by discussing the requirements for transplantation and immune effector cellular therapy. He will highlight opportunities and challenges when incorporating immune effector cellular therapy into an existing Quality Management Plan, and provide steps that can be taken to incorporate immune effector cellular therapy into a transplant program.
Other sessions within this series include:
- Bringing a Stand-Alone Immune Effector Cell Therapy Program into FACT Compliance (Date/time TBD)
- IEC Inspector Training (Date/time TBD)
- Data Reporting and REMS Compliance (Date/time TBD)
Programs must be confident in the identity of a clinical trial product. Programs have reported near misses due to labels on clinical trial products that use ambiguous identifiers, are handwritten illegibly, or do not link identifiers on the collected “starting material” with the final product that is returned to the program. When labeling is performed appropriately, clinical sites should be able to follow the chain of custody from collection to administration confirming exactly what the product is and the identity of donor and recipient.
What is it?
Cellular therapy products start with a collection (autologous or allogeneic), which is delivered either fresh or frozen to a manufacturing facility for processing, and then sent to the clinical site for administration to a recipient. This means there are at least three main points (but usually more) at which the identity of the product could be compromised. Unclear labeling of the product may result in undue delay or the inability to administer the product. Some manufacturers have agreed to use the ISBT 128 donation identifier (DIN), which can be assigned at collection and used throughout the manufacturing and administration processes.
Whose is it?
Cellular therapy (even in the case of many allogeneic cell therapy products) is personalized medicine. It is critical to get the right product to the right patient. Ambiguous identifiers prevent programs from linking a product to the correct patient. Many manufacturers have requested that only the study identifier be used on a product label. A study identifier is typically insufficient because 1) it is not unique to a specific product, 2) the meaning of the identifier is not typically known by personnel administering the product, and 3) various manufacturers may use similar or duplicative identifiers.
Where is it going?
In addition to knowing where a product is going, it is important to know where it has been. This is another purpose of unambiguous identifiers. Identifiers must allow collection facilities and manufacturers to proactively prevent product mix-ups and retroactively review records.
What does FACT expect?
FACT’s longstanding guidance on labeling of clinical trial products is that programs should comply with the IND as required, but FACT requirements that are not forbidden by or in conflict with the IND should be followed. Labels submitted as part of the Chemicals, Manufacturing, and Controls (CMC) section of Investigational New Drug (IND) applications or equivalent are approved by the appropriate regulatory authority (e.g., Food and Drug Administration [FDA] in the United States).
The seventh edition of the FACT-JACIE Hematopoietic Cell Therapy Standards requires full implementation of coding and labeling technologies using ISBT 128 or Eurocode. FACT believes the use of ISBT 128 is the most effective coding and labeling system that can be used for any type of cellular therapy product. Many research labels approved by regulatory authorities will not fully utilize this system.
However, the use of the donation identifier (DIN) at a minimum can be useful. The DIN is currently used on two commercially available chimeric antigen receptor (CAR) T-cell products, which demonstrates its effectiveness and feasibility as an identifier for commercial products.
It is understood that some manufacturers’ approved IND (or equivalent) labels must be used, but FACT-accredited programs are expected to use ISBT 128 to the extent possible. Accredited programs must define labeling responsibilities with commercial manufacturers and may wish to negotiate the use of ISBT 128. Programs may have different quality assurance approaches, and negotiations between a manufacturer and a program will often be site specific. However, patient identification procedures for almost any delivery of health care require two patient identifiers. In the absence of ISBT 128 coding and labeling, FACT encourages the use of at least two patient identifiers. Patient name and date of birth are acceptable identifiers for autologous products. Programs may have stricter requirements. In some cases, this may require that IND labels be supplemented with an additional identifier(s). The patient identifiers may be attached or on paperwork that closely accompanies the product.
We encourage clinical sites to work with commercial manufacturers to establish labeling procedures that will serve manufacturers’ needs while ultimately protecting the health and safety of the intended recipients of cellular therapy products.
It has been a long time coming, but now it is official. Full implementation of ISBT 128 coding and labeling is required of cellular therapy programs.
ICCBBA released an ISBT 128 compliance audit tool for use with cellular therapy products. The tool provides a means of determining compliance with the ISBT 128 Standard, and can be used by any cellular therapy facility around the world. It includes both interactive and printable audit checklists. FACT recommends use of this tool to verify correct implementation of ISBT 128 and to verify ongoing compliance. It may also be useful as an educational reference.
It is important to note that the tool does not take into consideration requirements from national regulatory bodies and may not cover all labeling requirements of cellular therapy accreditation bodies. Additionally, the tool does not ensure that proper Product Codes have been selected. Rather, it verifies correct placement and format of complete information.
Although ICCBBA has made validation tools available in the past, this is the first time an audit tool has been released. Input was received from industry experts and the international Cellular Therapy Coding and Labeling Advisory Group that is co-sponsored by ICCBBA, AABB, FACT, ISCT, and others. An instructional video is available on the ICCBBA website at www.iccbba.org.
FACT Webinar: ISBT 128 Coding and Labeling
June 14, 2018
Full implementation of ISBT 128 labeling and coding is required by the seventh edition of the FACT-JACIE Hematopoietic Cellular Therapy Standards, which becomes effective this month. On Thursday, June 14, 2018, at 11:00 am ET, Dr. Phyllis I. Warkentin will discuss common questions about ISBT 128 terminology, product codes, FACT Standards, and regulatory requirements. Webinar participants will have a chance to ask Dr. Warkentin questions at the end of the presentation.
WMDA-NetCord & FACT Cord Blood Day
September 14, 2018
Join your cord blood colleagues for a day of presentations from renowned cord blood experts at the inaugural WMDA-NetCord & FACT Cord Blood Day! The event will be held in Miami, Florida on September 14, 2018, in conjunction with the Cord Blood Connect international congress.
The WMDA-NetCord & FACT Cord Blood Day will highlight issues that affect cord blood banks’ abilities to optimize processes within a challenging environment. The evolving demand for umbilical and cord blood products requires banks to consider changing indications and financial limitations on a continuous basis. Accreditation encourages implementation of efficient, quality-driven processes to meet these demands while banking products suitable for clinical administration.
Morning presentation topics include global perspectives of cord blood transplants, ethical dilemmas in cord blood banking, common FACT-NetCord accreditation citations, and an overview of the WMDA cord blood bank survey. The afternoon has two breakout sessions including a FACT inspector training track and a WMDA-NetCord & FACT cord blood quality boot camp track. We encourage banks to send multiple personnel to attend the various tracks as well as enlist a member to become a FACT inspector.
This is an excellent opportunity to network with the cord blood community and learn from experts in cord blood banking. Register by August 31 and save $135! Registration fees are waived for FACT active and trainee inspectors.
Completing an Annual/Renewal Report in the Portal
Applicant Training Session
Join FACT’s IT Business Analyst for training on completing an annual or renewal report in the new FACT Accreditation Portal. Alisa Forsythe will discuss the navigation and features within the portal as well as the process for completing the application, the director approval process, and application submission. Webinar participants will have a chance to ask questions at the end of the presentation.
Completing a Compliance Application in the Portal
Applicant Training Session
Join FACT’s IT Business Analyst for training on completing a compliance application in the new FACT Accreditation Portal. Alisa Forsythe will discuss the navigation and features within the portal as well as the process for completing the application, the director approval process, and application submission. Webinar participants will have a chance to ask questions at the end of the presentation.
Performing an Inspection in the Portal
Inspector Training Session
Join FACT’s IT Business Analyst for training on performing an inspection in the new FACT Accreditation Portal. Alisa Forsythe will discuss the inspector specific navigation and features within the portal as well as the process for reviewing the applicant data, entering inspection findings, reviewing the inspection report, and submission. Webinar participants will have a chance to ask questions at the end of the presentation.