Integrated Source for Cellular Starting Material

One source, all under one roof

Gift of Life’s cell therapy operations – including its registry, donor center, collection center, cell therapy laboratory, quality systems and information technology – are housed under one roof at its 32,000 square foot South Florida headquarters. The facility has numerous redundancies in place, including centralized uninterruptable power supply, industrial grade backup generators, backup HVAC systems and more. Information Systems are fully redundant with an offsite secure data center.

Gift of Life’s international headquarters is in the heart of the highly regarded South Florida life sciences corridor, home to the Scripps Research Institute, Max Planck Institute, University of Miami, Florida Atlantic University and Torrey Pines Institute for Molecular Studies. Three international airports – Miami, Ft. Lauderdale-Hollywood and Palm Beach – are conveniently located within an hour’s drive and Boca Raton Airport provides access for private flights just two miles away.

Gift of Life commitment to quality and uniformity mandates that all aspects of the cell therapy procurement and processing supply chain are under one roof.

Single Source Solution

Centralized in our 43,560 square foot facility, staffed by over 135 professionals.

Gift of Life Marrow Registry

A registry of nearly 495,000 fully characterized allogeneic donors, with requests managed by an expert Donor Services team of case managers and logistics coordinators.

Dr. Miriam and Sheldon G. Adelson Gift of Life - NMDP Collection Center

A wholly owned state-of-the-art, high capacity, apheresis center dedicated to volunteer, unrelated donors.

Gift of Life Center for Cell and Gene Therapy

Cutting-edge, in-house certified laboratory offering high complexity testing, cell processing and isolation, GMP ISO Class 7 clean room suites, and cryopreservation services.

Cellect supply chain software

Since 1999, Gift of Life has developed its proprietary cell therapy supply chain software to power all aspects of its operations.

Cell Logistics and Distribution

30 years of supply chain management delivering cell therapies all over the world.

Donor Registry

Gift of Life Marrow Registry has been recruiting volunteer donors and facilitating hematopoietic stem cell transplantation for nearly 30 years.

All starting material for cell and gene therapy developers are sourced from the registry’s database of healthy donors, IRB consented and managed by Gift of Life’s Medical Services team. Qualified donors are collected at the registry’s owned and operated apheresis center.

Gift of Life operates a large and diverse registry of nearly 495,000 donors.

  • Through Gift of Life Biologics, cell and gene therapy developers will:
    • Have access to identify compatible donors for therapy development based on HLA typing and other key attributes including, but not limited to, BMI, Blood Type, CMV, Age, Sex and health history
    • IRB approved protocols and consent forms for the intended use of the starting material as either research, clinical or commercial development
  • Adelson Collection Center
    • The Collection Center’s highly trained staff of medical professionals, including physicians, APRNs, registered nurses, and logistics coordinators, work alongside donors throughout their experience to ensure efficiency in procuring a high quality, pure, and optimal product.
    • The apheresis collection center is AABB Accredited.
  • Moderate and High Complexity Testing, Processing, Isolation and Cryopreservation
    • The Gift of Life Center for Cell and Gene Therapy is a state-of-the-art, CLIA certified laboratory offering moderate and high complexity testing, cell processing and cryopreservation services.
  • Clean Room Processing Suites
    • The new facility can be used to develop and manufacture customized cell therapies, such as CD34+ cells or lymphocytes

Gift of Life by the Numbers

Registered Donors
494,159
Cell Therapy Treatments
5,490
Collection Center Donations
2,270

Starting Material Procurement

In 2019, Gift of Life was the first donor registry in the world to integrate a wholly owned and operated apheresis center into its operations. It did so with the intention of reengineering the apheresis procedure, focused on providing a world class hospitality experience in an effort to increase donor retention and availability.

The Adelson Gift of Life Collection Center is a high capacity and high availability facility solely focused on servicing the growing apheresis demand for allogeneic donations.

The Collection Center features seven apheresis stations utilizing Terumo’s Spectra Optia for the collection of HPC-A and MNC-A products.

The Collection Centers’ highly trained staff of medical directors and staff, registered nurses, and logistics coordinators, work alongside donors throughout their experience to ensure efficiency in procuring a high quality, pure, and optimal product.

Moderate and High Complexity Testing, Processing, Isolation and Cryopreservation

The Gift of Life Center for Cell and Gene Therapy is a state-of-the-art laboratory offering moderate and high complexity testing, cell processing and cryopreservation services. This in-house facility provides the benefit of regulatory compliance and assured quality from the outset, while avoiding the need to transport collected products to an off-site facility for preliminary characterization, processing, and target cell isolation procedures.

The lab is equipped with a central UPS with an industrial class backup generator, redundant HVAC, redundant flow cytometry (Navios and Cytoflex) redundant hematology (Sysmex and Coulter), redundant refrigeration, redundant BSCs, redundant cryo tanks, redundant CRFs (CryoMed and VIA Freeze) to ensure backup measures are in place.

One of the Center’s signature programs will be its BioBank of off-the-shelf on-demand cell therapy products available for starting material for further manufacture and ethical research. The inventory will consist of products collected from “super donors” with high frequency genetic characteristics sourced from the Gift of Life Marrow Registry.

High Complexity Testing

  • Beckman Coulter Navios EX Flow Cytometer
  • Beckman Coulter CytoFLEX Flow Cytometer x 2
  • Sysmex XN-1000R Hematology Analyzer
  • Sysmex XN-450 Hematology Analyzer

Cell Processing and Cryopreservation

  • Miltenyi Biotec CliniMACS Prodigy
  • Cytiva Sepax S-100 (aka Sepax 2) with SmartRedux and Pericell Protocols
  • Cytiva Smart-Max (for mixing, cooling, thawing and controlled cryoprotectant addition for both small and large products) with Cryo-SC Smart-Max Protocol
  • Cytiva VIAFreeze Controlled Rate Freezer
  • Thermo Scientific CryoMed Controlled Rate Freezer
  • Thermo Scientific 1300 Series Class II, Type A2 Biological Safety Cabinets
  • Chart Industries MVE 1894R-190 Tanks (Vapor Phase)
  • ThermoGenesis BioArchive System (LN2)
  • Thermo Fisher -80 Freezer
  • Thermo Fisher TSX REF Blood 23CD Blood Bank Refrigerators
  • ISO Class 7 Clean Room Suites for GMP processing

Potency Testing (CFU)

  • STEMCELL Technologies STEMvision
  • Thermo Scientific Forma Series 3 Water Jacketed CO2 Incubators

Clean Room Processing Suites

Gift of Life’s Cellular Therapy Laboratory is expanding its capabilities with the construction of a GMP cleanroom facility at its location in Boca Raton, Fla.

  • This new, state-of-the-art cleanroom will meet the increasing demand for cell therapy products
  • The new facility will be used to develop and manufacture customized cell therapies, such as CD34+ cells or lymphocytes
  • The GMP facility uses a modular cleanroom platform with two independent ISO 7 suites
  • The multi-purpose facility is expected to come on-line in the first half of 2023, and will include two independent cGMP modular cleanrooms

Custom Donor Search

Cellect™ now gives Gift of Life’s partners the opportunity to search our database of nearly 495,000 healthy donors and run filtered donor compatibility searches within the Gift of Life Registry based on characteristics such as:

  • Age
  • Gender
  • Location
  • BMI
  • Blood Type
  • CMV Status
  • COVID-19 History
  • Inclusive and Exclusive High Frequency HLA Typing
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Supply Chain Order and Tracking System

Gift of Life’s proprietary cell therapy supply chain software, Cellect, powers company operations.

When working with Gift of Life Biologics, our trained staff leverages Cellect to track all aspects of donor qualification, outreach and consent, verification testing, cell collection, cell processing, cryopreservation, biobanking and shipping.

Gift of Life’s proprietary Quality Management System is integrated into Cellect, automating and connecting quality and compliance across the entire organization and cellular product life cycle.

Cellect gives Gift of Life’s partners the opportunity to run filtered compatibility searches of the Gift of Life Registry based on HLA typing and other key attributes including, but not limited to, BMI, Blood Type, CMV, Age, and Sex.

Cell and gene therapy partners have direct and secure access to Cellect, providing full transparency to track order status through all stages of the supply chain.

This software is designed to help your team more effectively track the chain of custody and chain of identity for your starting material orders, hosting all information in an accessible and easy to use cloud based system.

Managed Logistics

Speed is of the essence and the vein-to-vein logistics that the Registry has perfected through the years carries over seamlessly to Biologics. It is a regular course of business to take great care in overseeing logistics, especially when the bone marrow and blood stem cell products are intended for immediate use in recipients.

Cellect’s supply chain software technology provides safe and secure visibility to track cell products as they move throughout Gift of Life’s supply chain and ultimately to the intended destination via a courier service. Case managers are all on call 24/7 to ensure your delivery needs are met and schedules are adhered to.

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