Abstract 15
Introduction
The Sydney Cord Blood Bank (SCBB) is one of the three public cord blood banks (CBB) in Australia, collectively known as AusCord. Each AusCord CBB is FACT accredited and TGA licensed. The FACT Standards mandate that a Stability Monitoring Program must be in place to ensure that long‐term storage of cord blood units (CBU) and routine processes that involve brief exposures to room temperature (i.e., potential warming events) do not negatively impact product quality attributes. The Program (FACT Standard D6.6) must involve the sampling of at least three CBUs from each manufacturing method across a range of storage periods. Methods at SCBB are categorized by volume reduction technology, cryopreservation method, and freezing bag. There are four methods defined at the SCBB that date back to 1995, resulting in the SCBB performing at least 12 product thaws per year.
Objective
To assess key product quality attributes from CBU (n = 3) manufactured with different methods (n = 4) across the duration of CBB operations. These included post‐thaw total nucleated cells (TNC) recovery, CD34+ cell viability, and CFU growth.
Methods
A schedule for CBU sampling was determined at the start of the year to ensure all manufacturing methods were selected accordingly and approved by key staff. CBUs were thawed and tested as per routine procedures. Results were reviewed against the AusCord Cord Blood Bank Quality and Release Criteria: TNC recovery (≥60%), viable CD34+ cell recovery (≥50% if same method as initial enumeration), CD34+ cell viability (≥70%), CD45+ cell viability (≥40%), and CFU‐GM (≥10,000 CFU‐GM per unit).
Results
All samples passed the acceptance criteria for the 2019‐2020 year (Figure 1).
Figure 1.
Stability monitoring results
Discussion
The findings demonstrated that routine procedures and storage at the SCBB have not resulted in deleterious effects on CBU product quality. The Stability Monitoring Program allows the CBB to detect any potential issues with storage or processing that require further investigations of relevant CBU (e.g., CBU processed on the same day). Continuance of the program is required to continually monitor the quality of products stored over an extended period of time, to define a potential expiration date for products, and to meet FACT Standards.