Success Story: Core23 BioBank
THE MEASURABLE IMPACT OF MEDIWARE
Start-up cord blood bank uses Transtem to automate operations and compliance, achieving profit in the first year.
Before Core23 BioBank opened its doors in January 2014, Michael Perry, director of business development, knew the facility needed to comply with a lengthy list of FDA regulations. He also knew that meeting the requirements, maintaining compliance and reliably documenting those efforts would require at least 10 highly trained staff members–or a powerful automated system that could handle a significant portion of the compliance workload.
Perry opted for Transtem, a comprehensive cellular therapy software application that provides complete process management, from online donor registration through product collection, storage and release. By using Transtem to get Core23’s workflow and regulatory practices in order from the business’s inception, Perry entered the market at a fraction of the cost of many cord blood banks.
DELIVERING QUALITY WHILE CONTROLLING COSTS
Core23 BioBank is a private cord blood bank located in Springfield, Mo. According to Perry, controlling costs and minimizing risk are important priorities, and the Transtem application is a key component in achieving these objectives.
The Bottom Line
“The Transtem solution was the most complete and comprehensive system we saw and the only one flexible enough to fit all of the needs of a cord blood bank.”
— Michael Perry, Director of Business Development, Core23 BioBank
Staffing for Quality
Some types of employees, such as quality managers, are federally mandated for cord blood banks. Because Transtem is a Web-based application, Perry is able to fill some of these positions with remote staff who work on a part-time basis, allowing Perry to recruit top-notch talent—which the young company might not be able to afford full-time—from anywhere in the world. With experienced and highly talented staff both accessible and affordable, Perry is able to meet his quality goals utilizing two full-time and two part-time staff members along with a six-person crew of contractors, only one of whom works full-time.
In addition to moderating staffing expenses, Transtem offers Core23 tremendous time and cost savings every day. Perry says that screening for risk factors is quick and easy, and managing inventory, from supplies and equipment to collection kits and stored samples, takes almost no time with bar-coded labels.
Perry also notes that Transtem allows him to save time by manufacturing collection kits in batches because the application tracks the kits’ component supplies and reagents. He says that, for a group of 10 kits, he saves an hour by entering the kits and their components all at one time and by avoiding the repetitive input of manually documenting the contents.
“Our workload is one-tenth of what it would be if we operated manually. Having all the key data and information all in one location is a tremendous benefit.”
Another typically time-consuming process, which also has potential for error, is documentation and reporting. With Transtem, though, it’s a simple matter that happens with the click of a button. For example, processing steps, including cell counts and product characteristics, are automatically captured and documented. “Our workload is one-tenth of what it would be if we operated manually. Having all the key data and information in one location is a tremendous benefit,” Perry says.
For Core23, the donor portal is another highly beneficial feature that allows this operation, in the heart of the Midwest, to effectively and efficiently reach donors across the country. Currently, the relatively new bank processes four to five units per month on average, but with recent facility upgrades and an outreach campaign in the works, Perry says he hopes to be processing 100 units each month by the end of 2015.
Transtem’s Web-based donor interface will play a key role in achieving this goal, in part because it’s easy for expectant moms to use for umbilical cord blood donation or banking. “The portal walks them through the process of registration and helps them complete their medical history and other documentation. And it saves their data, so moms can complete it on their time frame,” Perry explains.
“From day one, Transtem reduced our start-up costs, kept us in a mode of regulatory compliance and streamlined staff workflow.”
Adherence to federal regulations using a paper system is labor intensive and subject to human error, but the Transtem platform easily tracks donations, monitors quality control and manages all data related to the manufacturing and release processes. In fact, Perry appreciates that the system validates data at every stage and sends warnings when errors arise or when data is not within expected limits.
In addition, Transtem reliably tracks and monitors Core23’s collection kits and provides notification if kits, or the supplies and reagents within the kits, expire. Discrete inventory home pages provide a single source of information on each tracked item with one click, ensuring that Core23’s cord blood is safe for use whenever it’s needed.
Another critical feature that Perry relies on is the final checklist, which Transtem automatically produces once critical processes are complete, ensuring that all functions are documented. And when cord blood is requested from Perry’s facility, the final checklist, which includes a summary of the manufacturing, donor testing and other critical details, is supplied with the CBU and documents that all processes have been completed and that the product is safe for therapeutic use. “This is a huge risk mitigation feature,” Perry assures.
“I think the FDA should require all cord blood banks to use Transtem or something similar. When you see the difference between paper and automation—it’s like night and day.”
While Transtem is alleviating Core23’s risk issues, it’s also helping Perry to control costs and produce a higher quality product at the same time. As a result, Core23 has succeeded at delivering a profit in a short amount of time.
Therefore, Perry advises leveraging all the benefits of the Transtem system, regardless of the number of years you’ve been in operation. “I think the FDA should require all cord blood banks to use Transtem or something similar. When you see the difference between paper and automation—it’s like night and day.” And, with all the extra time he saves with Transtem, Perry says he can “focus on his passion and remain on the forefront of making a difference.”
About Core23 Biobank
Core 23 BioBank is a private cord blood bank in Springfield, Missouri. The bank provides the Midwest with an easy, safe and secure opportunity to save, or donate, a baby’s umbilical cord blood and cord tissue. It provides peace-of-mind for families knowing that their baby’s valuable cord blood is safe and secure. It is the bank’s mission to provide families the opportunity to take part in this new, and proven, modern medicine.