Clinical Grade G-CSF Mobilized Mononuclear Cells (MNCs) for Commercial Development
Key Biologics provides clinical-grade mononuclear cell (MNC) products collected from normal healthy subjects following five days of mobilization with approximately 10µg/kg of granulocyte colony-stimulating factor.
The study’s informed consent form (ICF) includes specific wording related to the intended use of the collected products:
“The blood product collected from participants in this study and cells that may be isolated from the blood product will be provided to researchers or research institutions, including commercial entities, to perform research and possible development of products used to treat various medical conditions. The blood cells collected in the study may be used in clinical trials (research studies in which participants receive investigational drugs that are not approved by the U.S. Food and Drug Administration (FDA), and used to possibly create specific blood cells and other products which will be sold as patient treatments.”
Also, specific wording is included to disclose that the products made from the collected products may have commercial value and that the subject will not retain any property rights to the materials and would not share in any financial benefits from any therapeutic products, tests or discoveries made using their product.
Subjects must be 18 to 50 years of age and are qualified in accordance with current regulations and requirements for donors of transfusable blood components, including screening with the uniform donor history questionnaire that was developed by the AABB Center for Cellular Therapies and accepted by the Food and Drug Administration for screening of donors of transfusable blood components.
Selection criteria may be adjusted at the request of the customer depending on the intended use of the product and the customer’s requirements provided that subject safety requirements and protocol requirements are met.
Subjects are prescreened for evidence of transmissible infectious diseases with the standard panel of tests used to screen blood products for transfusion acceptability. This panel of tests, with the exception of screening for exposure to T. cruzi, is usually repeated with each product collection. Testing for Zika virus RNA is performed on each collection.
Products can be collected on one of three devices as directed by the customer:
- Cobe Spectra collection system using the MNC collection protocol (note this device will no longer be supported by the manufacturer beyond 12/31/2017)
- Spectra Optia
- Fenwal Amicus Separator
A single leukapheresis is performed on the day following the final injection of G-CSF. Targets for total blood volume processed during the procedure are 10, 12.5 or 15 liters. However, actual processed volume may occasionally be lower than the target due to the donor’s inability to complete a full collection.
Autologous plasma can be collected concurrently with the leukapheresis. The plasma may be provided as a separate product or added to the MNC product before shipment. Additionally, storage media, e.g., HypoThermosol (BioLife Solutions), may be added if requested.
Specific subjects may be requested from our database based on criteria listed below and others. However, subject participation is dependent on subject’s willingness to participate and other inclusion/exclusion criteria specific to the protocol:
- Blood type
- Human Leukocyte Antigen phenotype.
Optional pre-collection qualification screening is available:
- Total white cell count, mononuclear cell count, and/or other cell counts
- Recent medication usage
Packaging and Shipment
In alignment with the intended use of the product and the customer’s requirements, mononuclear cell products are usually packaged and shipped on the date of collection for overnight delivery. Products are packaged in a manner that ensures maintenance of a temperature between 1°C and 10°C or between 20°C and 24°C during shipment at the customer’s discretion. Continuous temperature monitoring and data tracking devices are available at the customer’s request.