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16 BioPharm International ® Emerging Therapies 2022 eBook www.biopharminternational.com QC unit reviews the revised documents or labels to ensure they are correct. The approval for product release is provided only after all identified errors have been corrected. Currently, a post-apheresis review of documentation and labeling requires a minimum of 40 minutes. A real-time review process in action Prior to creating a real-time review process, organi- zations that support both collection sites and CGT sponsors can support protocol development. This assistance helps ensure that the research protocol requirements for documentation and labeling are within the abilities and regulatory standards of the institutions collecting the raw material. O nce t he s pon sor 's protocol i s comple te a nd the sponsor's requirements and documents are in place, the standard review process design can begin. This is the first step in putting the real-time review process into action. The process must be designed to be time-sensitive, precise, accurate, and repeatable for every review. The review organization will determine each ele- ment of the form or label that will be reviewed for each specif ic document. The process design wi l l occur with every new protocol—and sometimes on a site-by-site basis—because different collection sites may document a specific parameter in a different location on the institution's document, for example. This process-design step builds a controlled work aid checklist that enables a standard review process for each protocol that encompasses all the protocol requirements and all the documents. Training raw material collection sites Training the sites that will collect raw material for the protocol is the next critical step. One collection site may be collecting for six or seven protocols. Be- cause the desired level of documentation standard- ization has not been achieved in the industr y yet, each protocol may have slight variations. Therefore, this training must happen for each protocol. The training goal is to help the site understand the documentation requirements of the protocol, what the real-time review process entails, and the site's role and responsibility to documentation, real-time review, and product release. Ultimately, the initial documentation, the docu- mentation review, and the documentation verifica- tion is the role and responsibility of the collection site. A focused verification at the collection facility prior to a pre-release document review creates an effi- ciency that will reduce review time and avoid cellular raw material release delays. The real-time review by the QC unit is intended to catch errors that were not discovered during the site's documentation review and to correct those errors to avoid manufacturing delays. How CGT industry can support document integrity Document integrity is a critical element in the CGT industry. The varying protocols among CGT sponsors could increase the likelihood for document or labeling errors as more projects reach clinical trials and commer- cialization. While a real-time raw material documenta- tion and labeling review such as that described in this article can reduce errors, the industry must work toward standardization in the areas where it makes sense and agree on the areas where customization is necessary. By aligning in these areas, the industry can avoid the risks associated with document errors that could lead to a negative patient outcome. Aligning will require stakeholders across the in- dustry to get involved in efforts, such as those led by the Standards Coordinating Body (SCB). For example, different stakeholders use different tracking systems and formats. An SCB working group is currently work- ing on definitions and key requirements for a stan- dard COI identifier that would allow for consistent and efficient tracking of CGTs throughout collection, production, and delivery. The SCB group's goal is to avoid errors that could lead to the wrong therapy being administered to a patient (2). Industry stakeholders must be willing to review, evaluate, and revise their documents and standardize where possible. The evaluation includes reviewing the errors that are occurring and determining if some er- rors are due to form design or lack of clarity and could be avoided with revisions. Finally, the real-time feedback loop described in this article should be a standard implementation. It is not valuable to provide only an annual performance report. It is more impactful to provide immediate feedback to the team involved in that collection to immediately resolve an error and provide a greater understanding of the requirement. In CGT, the stakes are high. The therapies in de- velopment provide hope and opportunity for people who oftentimes have no other treatment options. The industry must act to ensure document integrity and avoid errors to avoid risk to patients. References 1. E. Schaller and J. Tilbury, "Criticality of Document Integrity in Provision of Raw Materials for Cell and Gene Therapy Manufacturing," poster presentation at the ASFA 2022 annual conference (Philadelphia, Pa., May 4–6, 2022). 2. Standards Coordinating Body, "Project: Chain of Custody/Chain of Identity," www.standardscoordinat- ingbody.org/project-chain-custody-identity, accessed May 20, 2022. ■