10 Must-Follow Regulatory Compliance Checks for Storing Biological and Cell Therapy Samples in 2025
In the rapidly evolving landscape of cell and gene therapies, maintaining regulatory compliance for biological sample storage isn’t just good practice, it’s essential for patient safety, product integrity, and business continuity. As regulatory frameworks continue to evolve in response to technological advancements and emerging therapies, organizations must stay vigilant about compliance requirements and how to implement a validated storage system. The stakes couldn’t be higher. A single compliance failure can result in compromised patient safety, regulatory actions, financial penalties, and irreparable damage to reputation. For cell therapy CDMOs, biobanks, and other patient-centric organizations, understanding and implementing these critical compliance checks …
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 …