Survey Respondents Needed to Help Shape Staff Training for Apheresis, Cord Blood Collections
As part of an international collaborative project among the Alliance for Harmonisation of Cellular Therapy Accreditation partners, we are asking you to complete an important survey that will be used to help AHCTA develop recommendations for training staff performing collections of apheresis and cord blood stem cell transplant products. It is expected that with an international overview of current training practices, a consensus document for training and competency will be produced that will allow centers to compare or benchmark their practices with other centers and offer good examples for adoption or implementation. Each facility is asked to provide one response; you may need to collaborate with your colleagues to accomplish this.
ISBT 128 Pioneers: Share Your Labeling Examples With the Community
Just over half of accredited facilities worldwide that participated in a recent survey say they have implemented the ISBT 128 label design on their cell therapy products. Are you ahead of the curve on ISBT 128 labeling for your cell therapy products? Are you willing to share examples of your work with colleagues? If so, please submit your sample labels by Feb. 28. Examples will be posted on the ICCBBA website as a resource for others in the community. Depending on the response rate, it may not be possible to post all submissions.
Summary of Latest Cellular Therapy FDA Liaison Meeting Now Available on AABB Website
A summary of the most recent meeting of the Cellular Therapy FDA Liaison Meeting with stakeholders has been posted. The Oct. 21, 2010, meeting featured presentations from Dr. Dennis Confer and Dr. John Miller of the National Marrow Donor Program on unrelated donor hematopoietic progenitor cell apheresis usage under the NMDP-held investigational new drug application and unrelated donor experiences. Also included was a presentation by Dr. Corina Gonzalez of Georgetown University Hospital describing her hospital's approach in performing approximately 100 peripheral blood stem cell donation collections per year on donors who primarily come from outside of its geographical area.
Annual Meeting and CTTXPO
AABB Offers Something for the 'Re'-Generation at 2011 Annual Meeting
Interested in regenerative medicine and its latest developments? Plan now to attend the AABB Annual Meeting and CTTXPO this fall. The preliminary program will be posted in April and contains a broad range of regenerative medicine and translational development sessions you will not want to miss. Stem cell-based therapeutic applications in opthalmology, writing the CMC section of an IND, using project management techniques to develop CT products, a double-feature bench-to-bedside session, and the always-popular TERMIS North America session are just a few of the offerings in this year's program. As travel dollars are always tight, consider submitting an abstract and attending the premier networking and educational experience for CT professionals!
Call for Abstracts Opening Soon for 2011 Annual Meeting
Abstract submission opens Feb. 23 for those interested in submitting a proposal to be considered for presentation at the AABB Annual Meeting and CTTXPO to be held Oct. 22-25 in San Diego. Check the AABB website regularly for updates on the the educational program and exciting new networking opportunities.
CT Section News
Common Interests Bring Several Subsections Together
Recognizing some overlapping interests, several of the original 10 subsections were merged to form a total of seven groups embracing members from all parts of the CT community. The Bone Marrow and Apheresis Collection Subsection combined with the CT Clinical Practices Subsection to create the CT Product Collection and Clinical Practices Subsection, which primarily focuses on clinical topics associated with the collection, transport, utilization and outcomes of cellular therapy products. The Novel CT Therapies and Regenerative Medicine Subsection merged with the CT Product Development and Tech Transfer Subsection to form the Novel Therapies and CT Product Development Subsection. This group works on new research and preclinical studies, new devices for manipulating cells as well as later-stage cellular product development, validation, and technology transfer for clinical production. A sample validation plan for cryopreservation containers is available online. CT Product Manufacturing and CT Product Assessment have combined to become the CT Product Manufacturing and Testing Subsection, which covers technical topics and operational aspects related to the manufacturing and testing of CT products such as cryopreservation, cell separation and selection, automation, product characterization, assay development, validation, and implementation.
As a valuable member benefit, anyone interested in participating in a subsection or multiple subsections can enroll through the AABB website. Not a member? Don't miss out any longer — join AABB today.
Case Study, Survey, Quality Plan Template Among New Projects
Several CT subsections produced a number of member resources this winter, including a case study, findings from a survey and a quality plan template. Most recently, the Product Manufacturing and Testing Subsection — before its merger with the CT Product Assessment Subsection — developed a case study on the storage of hematopoietic progenitor cells and therapeutic cells. The study addresses issues to consider when designing a validation study, goals of short-term storage, temperature, cell concentration, manipulation and other topics. The Regulatory Affairs Subsection posted findings of a snapshot survey looking at members' experiences with Food and Drug Administration inspections of HCT/Ps ,which included questions on inspections done and what parts of the Code of Federal Regulations posed the greatest challenges to facilities. And lastly, the CT Quality Operations Subsection developed a quality plan template as a resource to members. The document, which is organized according to AABB's 10 Quality System Essentials, includes a list of important points to consider for the elements cited in the document as well as further expansion of key points defined in AABB's Standards for Cellular Therapy Product Services. In addition to developing original projects, sometimes subsection members can offer their expertise to pre-existing projects. Members of the Business Management Subsection applied their expertise in helping to revise the AABB Billing Guide. The updated version will be posted this spring.
CT Community Now Serving Over 100 Members and Counting
If you're using the BactT system for sterility testing, how long are you storing culture samples? Are you adding a third bottle for fungus? Regarding a proposed new standard, how do you assess a product for potential hemodilution? This is just a taste of some of the topics being discussed in the Cellular Therapy Group of the AABB Community, which continues to grow. It's easy for anyone interested to join these discussions or create your own. Just navigate to the AABB Community section of the website, then click "Enter AABB Community," "Find a Group," and join the Cellular Therapy Group. To be sure that you do not miss out on any new postings, sign up to receive e-mail alerts whenever a new question or comment appears. To sign up for alerts, click on the golden alarm bell that is visible once you enter the "Discussions" section for the group.
You're Invited! Transfusion Journal Seeks Cell Therapy Submissions
To address the growing field of cell therapy, Transfusion is specifically seeking submissions from professionals who have embraced this dynamic field. To read more about the journal and how to submit an abstract, visit the manuscript submission Web page, or if you are a member, visit the AABB website and click on the Transfusion journal image to access the journal.
CBER Office Offers Tutorials on IND Application Process
The Center for Biologics Evaluation and Research's Office of Cellular, Tissue and Gene Therapies is offering a series of online tutorials aimed at providing assistance to establishments submitting investigational new drug applications. The OCTGT Learn course list has eight tutorials, including an introduction on the scope of OCTGT and IND basics. OCTGT also provides a tutorial, presented by Samuel Barone, called "'361' Human Cells, Tissues, and Cellular and Tissue Based Products," which defines human cells, tissues, and cellular- and tissue-based products and how they are regulated, which will be of interest even if an IND is not contemplated. In addition, each course offered includes a survey. Additional online courses may be developed and will be posted in the future; the office welcomes submissions of other potential topics to cover.
CT Educational Calendar Filling Up for 2011
Trying to learn more about topics involving cell therapies? Interested in getting up to speed on the latest edition of AABB's cell therapy standards? If so, AABB has educational programming to meet your needs. Nearly a dozen audioconferences relevant to cell therapy professionals will be offered throughout the year, including sessions on proficiency testing, cord blood banking and transplantation, cell-based therapies for immune modulation, and much more. Be sure to visit the 2011 audioconference calendar for a complete listing of sessions.
Multicenter BEST Collaborative Report Assesses Storage Characteristics of Cord Blood Progenitor Cells
The Biomedical Excellence for Safer Transfusion, or BEST, Collaborative, motivated by findings of a recent survey conducted by its CT group, initiated a multicenter laboratory study assessing the impact of temperature, cell density and time on HPC viability in cord blood units. For the study, researchers collected total nucleated cell and mononuclear cell counts, viable CD34-positive cell counts, and CD45-positive cell viability as well as colony-forming unit-granulocyte-macrophage data on cord blood samples stored at 4 C versus room temperature for up to 96 hours. Storage at 4 C was preferable to room temperature for HPC, cord blood units, and immediate processing was recommended.
Transfusion Article Looks At Growing Impact of Cellular Therapy in Transfusion Medicine
In the November issue of Transfusion, authors Edward Snyder and Jacquelyn Choate discuss how in a span of 20 years, practitioners in the field of transfusion medicine have become active participants in the cellular therapy field. They identify "several seminal events" that helped stimulate the incorporation of cellular therapy into the realm of transfusion medicine, including the development of apheresis in the 1970s, the discoveries of the hematopoietic cytokines, granulocyte and granulocyte/macrophage colony-stimulating factor, and the CD34 antigen on a population of mononuclear cell counts. It is a compelling read for those interested in how disciplines can evolve or grow together.
Review Examines Regenerative Medicine's Move Toward Commercialization
Julia Polak, Christopher Bravery and Catherine Prescott review a series of papers that explore the various issues facing regenerative medicine as a new multidisciplinary field in the December issue of the Journal of the Royal Society Interface. The review looks at the progress being made in addressing the scientific obstacles of regenerative medicine as well as quality standards and safety issues. The authors note papers that discuss identifying the appropriate cell or cell population, the need to assess the biodistribution of the cells, and the impact of regenerative medicine as a new way of thinking, among a number of other papers that explore how the field is progressing.