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901-252-3431

Mononuclear Cells (MNCs)

Apheresis-Derived Mononuclear Cells (MNCs)
Key Biologics provides research- and clinical-grade mononuclear cell (MNC) products.
  • Non-mobilized
    • Key Biologics' protocol - IRB-approved for collections from normal subjects
    • Sponsor’s IRB-approved protocols for collections from normal subjects or subjects with specific health history
  • G-CSF Mobilized
    • Key Biologics' protocol - IRB-approved for collections from normal collections
    • Sponsor’s IRB-approved protocols for collections from normal subjects or subjects with specific health history
Non-Mobilized Normal Subjects (Key Biologics' Protocol - IRB-Approved)
Key Biologics collects mononuclear cell (MNC) products under an IRB-approved protocol from subjects 18 to 65 years of age and qualified in accordance with current regulations and requirements for donors of transfusible blood components, including screening with the Uniform Donor History Questionnaire that was developed by the AABB and accepted by the Food and Drug Administration for screening of donors of transfusible 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.
We also offer qualification samples on potential subjects to allow the end-user to determine suitability for targeted applications. Specific subjects may be requested for product collection. Subjects may donate as often as every 2 weeks and up to twenty-four times in any 12-month period.
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.
Products can be collected on one of three devices as directed by the customer:
  • COBE© Spectra collection system using either the MNC or AutoPBSC© collection protocol (note this device will no longer be supported by the manufacturer beyond 12/31/2017)
  • Spectra Optia©
  • Fenwal Amicus
The total volume of blood processed during the collection procedure is as directed by the customer provided that subject safety requirements are met. The standard processed volumes are 10 liters, 12.5L or 15L. However, products collected after processing only 5L or 7.5L are available.
Autologous plasma can be collected concurrently with the leukapheresis. The plasma may be provided as a separate product or added to the MNC product prior to shipment. Additionally, storage media, e.g. HypoThermosol© (BioLife Solutions©) may be added if requested.
Specific subjects may be selected from our database based on:
  • Blood type
  • Gender
  • Ethnicity
  • 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
Optional post-collection release screening is available:
  • Total nucleated cell count, mononuclear cell count, and/or other cell fraction yield
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 data tracking devices are available for use at the customer’s request.
Non-Mobilized Research Subjects Collected Under Sponsor’s IRB-Approved Protocol
Key Biologics supports many companies’ research needs by recruiting, screening, consenting, and enrolling subjects in IRB-approved research studies that require collection of mononuclear cell products for specific process development and process validation uses, and/or for further manufacturing for clinical research. In addition, Key Biologics provides other support services that allow a study sponsor to initiate and complete studies in a time-efficient and cost-effective manner.
These products are 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 as per protocol requirements.
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 or AutoPBSC© collection protocol (note this device will no longer be supported by the manufacturer beyond 12/31/2017)
  • Spectra Optia©
  • Fenwal Amicus
The total volume of blood processed during the collection procedure and other collection parameters are as defined by the protocol and/or the study sponsor.
With the available collection platforms, a sponsor can gain a comparison 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.
Packaging and Shipment
In alignment with the intended use of the product as directed by the protocol and/or the study sponsor, 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 as specified in the protocol and/or by the customer.
Continuous temperature monitoring data tracking devices are available for use at the customer’s request or as defined by the protocol.
G-CSF Mobilized Normal Subjects (Key Biologics' Protocol - IRB-Approved)
Key Biologics is performing 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 cannot be provided for clinical use.
As part of this study, three G-SCF 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 processed blood volumes are 10 liters, 12.5L or 15L. Collections using smaller 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 Data), taken from a poster presented at the recent ISCT meeting in Singapore, provide average and ranges for cell yields from over 380 consecutive recent collections by schedule and TBV processed.
Products can be collected on one of three devices as directed by the customer:
  • COBE© Spectra collection system using either the MNC or AutoPBSC© collection protocol (note this device will no longer be supported by the manufacturer beyond 12/31/2017)
  • Spectra Optia©
  • Fenwal Amicus
G-CSF mobilization is routinely performed using a filgrastim biosimilar; however, if requested by the customer filgrastim can be used.
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.
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. In addition, Key Biologics provides other support services that allow a study sponsor to initiate and complete studies in a time-efficient and cost-effective manner.
These products are 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.
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 or AutoPBSC© collection protocol (note this device will no longer be supported by the manufacturer beyond 12/31/2017)
  • Spectra Optia©
  • Fenwal Amicus
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)

Fax: 901-252-3446

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