• Non–Mobilized Normal Subjects (Key Biologics' Proprietary Protocol – IRB–Approved)
• Mobilized Normal Subjects G-CSF (Key Biologics' Proprietary Protocol – IRB–Approved)
• Mobilized Normal Subjects Plerixafor (Key Biologics' Proprietary Protocol – IRB–Approved)
• Mobilized Normal Subjects G-CSF + Plerixafor (Key Biologics' Proprietary Protocol – IRB–Approved)

Mobilized Normal Subjects G-CSF + Plerixafor (Key Biologics' Proprietary Protocol – IRB–Approved)

Key Biologics' (A Cellero Company) 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. 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. Key Biologics' staff will submit the protocol and manage it to approval.

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 transfusable 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 transfusable 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. Testing for Zika virus RNA and exposure to T. cruzi are performed on each collection. Testing for exposure to Babesia microti is performed for donors in selected geographic regions in accordance with FDA recommendations.

• Terumo BCT Spectra Optia^®
• Fenwal Amicus Separator

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.

Collection Schedule

Products are collected on the schedule directed by the Sponsor but are usually collected Monday through Thursday. Collections in the morning are usually completed by 12:00 noon CT and afternoon collections are usually completed by 16:00 CT. 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.