CASE STUDY : Partnering with NYBC to Transform Their Cord Blood Storage and Distribution
A case study demonstrating how Pragmatrix’s GMP-compliant sample inventory management solutions helped the New York Blood Center (NYBC) optimize their cord blood storage and distribution while maintaining strict FDA regulatory compliance
Building the Infrastructure for NYBC’s Life-Saving Cord Blood Program
For over five decades, the New York Blood Center (NYBC) has played a critical role in healthcare across New York and New Jersey. As a non-profit organization committed to public health, NYBC delivers essential blood products, transfusion services, and public health research to support a population of over 20 million people.
Central to this mission is the National Cord Blood Program (NCBP). It demands an infrastructure that supports strict FDA regulations and Good Manufacturing Practices (GMP), while maintaining operational efficiency. Managing such a sensitive and regulated process takes more than spreadsheets. Through multiple phases of collaboration, implementing a Sample Inventory Management System became NYBC’s key to improving traceability and maintaining regulatory compliance in its cord blood operations.
Solution 1: The World’s First Cord Blood Unit Search Engine
The cornerstone of Pragmatrix’s partnership with NYBC was the development of a pioneering search engine that revolutionized how transplant centers (TCs) locate compatible cord blood units. This FDA-compliant system implements sophisticated HLA typing search algorithms that identify potential matches between patients and donors.
For 16 years, this system has provided TCs with secure access to:
- Register patients in need of transplants
- Search NYBC’s extensive cord blood inventory
- Identify optimal cord blood products based on HLA compatibility
- Generate comprehensive reports for regulatory documentation
Each step in this process follows Standard Operating Procedures (SOPs) defined by GMP guidelines, ensuring all exchanges meet FDA regulatory requirements.
Solution 2: National Marrow Donor Program (NMDP) Integration
Building on the success of the search engine, Pragmatrix facilitated a strategic collaboration between NYBC and the National Marrow Donor Program (NMDP). This initiative involved developing a B2B data exchange platform for HLA typing searches with seamless server-to-server integration.
Under a HRSA agreement, this connection significantly expanded public access to cord blood units by:
- Creating a secure bridge between NMDP and NYBC systems
- Implementing rigorous data validation protocols
- Ensuring all exchanges meet FDA regulatory requirements
- Maintaining complete audit trails for regulatory compliance
This integration exemplifies how technology can expand access to life-saving resources while maintaining the stringent documentation required in GMP environments.
Solution 3: Sample Management and Distribution System (SDMS) for Cord Blood
Laboratory operations in cord blood banking demand precise tracking and meticulous documentation. Pragmatrix designed and implemented a comprehensive Sample Management and Distribution System (SDMS) for NYBC labs that addressed these critical needs.
The system includes:
- Streamlined sample tracking within clean room environments
- Integration with complex airlock systems
- Implementation of Chain of Identity (COI) and Chain of Custody (COC) protocols
- Barcode technology for error-free identification
- Robust data analytics capabilities
- Complete documentation for FDA audits
This solution ensures that every sample movement is recorded, validated, and traceable adhering to key requirements for GMP compliance in biological sample handling.
Solution 4: Cryopreservation Freezer Monitoring with PragLife
Perhaps the most critical aspect of cord blood banking is the long-term preservation of these valuable biological materials. Pragmatrix’s PragLife solution plays a vital role in safeguarding NYBC’s cryopreserved assets by:
- Integrating with liquid nitrogen-based freezers
- Providing continuous temperature and status monitoring
- Generating automated alerts for any deviations
- Creating comprehensive data logs for regulatory documentation
- Ensuring all processes meet FDA validation requirements
This advanced technology enhances NYBC’s ability to maintain optimal conditions for long-term preservation while creating the documentation necessary for regular FDA inspections.
Results: A Partnership That Improves Lives
The collaboration between NYBC and Pragmatrix Technology demonstrates how specialized GMP software solutions empower healthcare organizations to achieve their mission while navigating complex regulatory requirements. The results of this partnership include:
- Enhanced patient care through faster, more accurate cord blood unit matching
- Streamlined laboratory operations with complete regulatory documentation
- Expanded access to life-saving cord blood units
- Improved protection of valuable biological materials
- Successful FDA audits and inspections
- Facilitation of groundbreaking research initiatives
Conclusion: A Blueprint for Scalable, Compliant Sample Management
The NYBC case study illustrates Pragmatrix’s unique understanding of both technological innovation and healthcare regulatory requirements. By developing solutions that incorporate GMP principles, FDA compliance, and SOP documentation directly into their functionality, Pragmatrix has helped NYBC maintain their vital mission for over a decade and a half.
As the healthcare industry continues to evolve, the partnership between NYBC and Pragmatrix remains focused on leveraging compliant technology to improve operational efficiency, maintain regulatory standards, and ultimately, save more lives through advanced cord blood banking.
To learn more about how Pragmatrix Technology can help your Life Sciences organization achieve regulatory compliance while optimizing operations, contact us today.
