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G-CSF mobilized Mononuclear Cells Sourced, Processed, Qualified and Delivered According to Intended Use and to Your Specifications 

Blood cells
G-CSF Mobilized Normal Subjects collected under Key Biologics' IRB-Approved Protocol - active since 2006.
Key Biologics is conducting a research study to evaluate the impact of G-CSF mobilization schedules, product collections, and repeated G-CSF mobilization and product collections on normal subjects. Products collected as part of this study can be provided for use in pre-clinical research, process development, process validation, and device validation. Products from this protocol are not provided for clinical use; however, we have another active protocol  that does allow products to be used for clinical/commercial use.
As part of this study, three G-CSF mobilization options are available:
  • 4-10-1: 10µg/kilogram body weight X 4 days, single collection on day 5
  • 5-10-1: 10µg/kilogram body weight X 5 days, single collection on day 6
  • 5-5-2: 5µg/kilogram body weight X 5 days, 2 collections, one on day 5 and one on day 6
The standard targeted processed blood volumes are 10 liters, 12.5L or 15L however, actual processed volume may occasionally be lower than the target due to the donor’s inability to complete a full collection. Collections using smaller targeted processed blood volumes are not performed; however, aliquots of collected products can be provided for customers who do not need a full product. Aliquots are offered based on product volume or total cell count.
Several factors impact the total number of nucleated cells or CD34+ cells in these products including the subject’s biologic response to G-CSF, which may be independent of the dose administered and the volume of blood processed during the collections. Tables on the PDF Files tab (ISCT 2016) provide average and ranges for cell yields from nearly 500 consecutive recent collections by schedule and TBV processed.
Products can be collected on one of three devices or paired collections can be performed on multiple platforms for product comparisons if preferred 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
G-CSF mobilization is routinely performed using a filgrastim biosimilar and customer may specify which filgrastim biosimilar is used, if preferred. Also, if requested by the customer, filgrastim will be used. 
Collection Schedule
Products are generally collected Monday through Thursday. Collections in the morning are usually completed by 12:00 and afternoon collections are usually completed by 16:00. Options exist for a customer to request either a morning or evening collection if there are concerns about transit time from end of collection until arrival for processing. Multiple collections for a single customer can be performed on the same day. 
Packaging and Shipment
Collected 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.
 
Continuous temperature monitoring data tracking devices are available for use at the customer’s request.
Shipping options for these high-value products include commercial cargo carrier, e.g. FedEx or UPS, commercial passenger airline with couriered transfer and also commercial passenger airline with on-board courier to minimize handling and allow reduce shipment times. With the latter option, transport times to Europe and Australia are less than 36 hours from end of collection to product receipt.
G-CSF Mobilized Normal Subjects Collected Under Sponsor’s IRB-Approved Study 
​Key Biologics supports many companies’ research needs by recruiting, screening, consenting, and enrolling subjects in IRB-approved research studies that require collection of G-CSF mobilized mononuclear cell products for specific process development and process validation uses, and/or for further manufacturing for clinical research. These may be performed under a Sponsor’s existing protocol by adding Key Biologics as a collection site or a customer-specific protocol can be drafted jointly by the customer and Key Biologics and Key Biologics’ staff will submit the protocol and manage it to approval.
These products are usually collected from subjects qualified for participation in accordance with the specified IRB-approved inclusion and exclusion criteria. In addition, most subjects are also qualified in accordance with current regulations and requirements for donors of transfusible blood components, including screening with the Uniform Donor History Questionnaire developed by the AABB and accepted by the Food and Drug Administration for screening of donors of transfusible blood components. Depending on the intended use of the collected products and protocol specifications, subjects with a history of travel or medication ingestion that would preclude them from providing a blood product suitable for transfusion may participate and provide MNCs for a study.
In accordance with the study protocol, subjects can be 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 or paired collections can be performed on multiple platforms for product comparisons if preferred by the customer:
  • COBE© Spectra collection system using either the MNC collection protocol (note this device will no longer be supported by the manufacturer beyond 12/31/2017)
  • Spectra Optia©
  • Fenwal Amicus Separator
Mobilization is routinely performed using a filgrastim biosimilar; however, if required by the Sponsor's protocol, filgrastim will be used. Additionally, plerixafor could also be used under a sponsored study.
With the available collection platforms and mobilization options, a sponsor can gain a comparative view of products collected under many varied conditions. This is especially useful for a sponsor seeking to qualify collection platforms and/or parameters for collection of products for further manufacturing.
The total volume of blood processed during the collection procedure and other collection parameters are defined by the protocol and/or the study sponsor.
Packaging and Shipment
Collected 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. Continuous temperature monitoring data tracking devices are available for use at the customer’s request.
Key Biologics, LLC
1256 Union Ave.
Memphis, TN 38104-3411
Phone: (901)252-3434 (Donation questions)
(901)252-3431 (Product questions or inquiries)
Fax:(901) 252-3446
Business Hours
Mon - Thu: 08:00 AM - 12:00 PM
Fri: 08:00 AM - 12:00 PM