You have just been notified that the manufacturer of your dimethyl sulfoxide preparation has been acquired by a different company. The new product literature indicates that the cryopreservative will be manufactured at the new company’s facilities. Is this a new supplier? A new supply?

These and other questions were addressed in “real time” by 125 cellular therapy professionals led by Zbigniew "Ziggy" Szczepiorkowski, MD, PhD, FCAP, from Dartmouth-Hitchcock Medical Center, and Lynn O’Donnell, PhD, from Ohio State University Medical Center. Of the participants, 59% were from hospital-based facilities, 13% each were from independent blood centers and cord blood banks, and 5% were from biotech facilities. Demographics of the audience participants are shown in the accompanying pie chart.

In the interactive session, which featured immediate feedback technology, Szczepiorkowski and O’Donnell led the discussion as the audience members used their communicator devices to cast their votes on a variety of cellular therapy processing scenarios. The results were immediately displayed on charts and graphs, providing an excellent vehicle for audience discussion and debate.

Topics included product volumes processed, staffing qualification requirements, salary levels and pay models (salary versus hourly).  A lively discussion of current practices, creative approaches and some of the challenges followed. Next, participants were given scenarios and asked how they would handle specific situations.  Product transport, temperature monitoring and ways validation is performed on containers were discussed in detail. The consensus was that the temperature in product storage containers should be tested for durability in extreme conditions and that anyone with data should publish his or her findings. 

Red cell reduction methods, triggers for red cell depletion and transfusion reactions were the next topics. Proficiency testing (PT) generated much discussion as a representative from one center shared the experience of being cited by the College of American Pathologists (CAP) for sending a portion of the facility’s PT sample to a microbiology lab. The moderators explained that in recent correspondence between CAP and the Centers for Medicare and Medicaid Services (CMS), it has been established that PT for cellular therapy products that are tested by subspecialty laboratories does NOT violate CMS rules. The rationale is that a cellular therapy product is a product and not a patient’s specimen and hence not regulated by CLIA. 

Environmental monitoring practice; product disposal; and the methods, sample volumes, and logistics of microbial testing rounded out the session. For product disposal, 52% reported having agreements and procedures for disposal of patient products after patient death. Seventy percent of participants reported using both aerobic and anaerobic culture tubes. Others used only aerobic systems or fluid thioglycollate. 

If audience response is any indication, the use of this interactive technology was a real success for cell therapy professionals in just one of several interactive and networking sessions in cell therapy at the meeting. The moderators announced they would be sharing the complete results at some time in the future and look forward to having expanded sessions of a similar format next year!