Sanguine Connections: The Anatomy of a Sanguine LeukoCert™ GMP Leukopak

December 16, 2024
Welcome to Sanguine Connections, exploring the process, challenges, and nuances of biospecimen procurement for translational studies.

 

Sanguine Connections

The Anatomy of a Sanguine LeukoCert™ GMP Leukopak

 

Good Manufacturing Practices (GMP) are rigorous standards enforced by the FDA in the United States. They encompass production, documentation, testing, and quality control processes to ensure the safety, consistency, and efficacy of products, especially when intended for therapeutic use. GMP-grade leukopaks are utilized in both autologous and allogeneic therapies, where white blood cells are collected from either the patient or a donor, respectively, for therapeutic manipulation.

At Sanguine, our LeukoCert™ GMP-grade leukopaks and LeukoCore™ RUO (Research Use Only) leukopaks share a common foundation. Both healthy donor products are collected at our ISO-certified apheresis center, ensuring high-quality and reliable starting materials. However, LeukoCert™ leukopaks include additional testing, quality controls and documentation critical for GMP compliance.

 

Key Differences: LeukoCert™ vs. LeukoCore™

Enhanced Documentation

Documentation is central to GMP processes, covering every step from donor qualification to equipment calibration and personnel training. The LeukoCert™ Certificate of Analysis (CoA) goes beyond the standard RUO CoA to include:

  • Collection Details: Facility, apheresis machine used, collection volume, and collection start and end times
  • FDA Title 21 CFR 1271 Testing: Assurance of compliance with regulations focused on preventing communicable disease transmission, including additional infectious disease testing

All of our LeukoCert™, as well as LeukoCore™ collected at our apheresis center, are ISBT 128 Compliance – a globally recognized labeling and coding standard for human-origin products. 

 

Advanced Infectious Disease Testing

LeukoCert™ leukopaks undergo more extensive infectious disease testing compared to LeukoCore™.

Reserved Donors for GMP

LeukoCert™ donors are reserved for specific projects, ensuring consistency and traceability. Reserved donors must meet stringent criteria, including:

  • A history of successful donations with high cell yields.
  • An interest in frequent donation (every six weeks).
  • Completion of extensive infectious disease screening.

While LeukoCore™ uses recallable donors, the reserved donor model for LeukoCert™ provides an added layer of assurance for therapeutic applications.

 

Detailed Donor Data

Both LeukoCert™ and LeukoCore™ leukopaks include demographic details (age, gender, ethnicity, height, weight, medications). Additionally LeukoCert includes HLA-typing using targeted NGS HLA Class I/II and blood type. 

 

Seamless Transition from RUO to GMP

Since RUO and GMP leukopaks are collected using the same robust protocols, transitioning from LeukoCore™ to LeukoCert™ is seamless. RUO leukopaks collected from GMP-qualified donors provide a reliable bridge to GMP-grade materials.

With Sanguine, you can trust the consistency, quality, and traceability of our leukopaks at every stage of your research and development journey.

 

Learn more about Sanguine’s Apheresis portfolio.

 

 

 

By: Eliza Small, Ph.D.

Director, Content Marketing at Sanguine