Plerixafor Mobilized Normal Subjects (Key Biologics' IRB-Approved Protocol), Active Since 2020

Key Biologics' (A Cellero Company) is conducting a research study to evaluate the impact of plerixafor for stem cell mobilization on normal subjects including assessment of the quality of collected products. The protocol includes a single injection of plerixafor (~24ug/kg body weight) followed by a leukapheresis performed the same day, approximately 4–5 hours following the injection. This schedule allows the subject to complete the injection and collection on the same day. Several studies have shown that plerixafor mobilization peaks within 6 hours of the dosing.

Products collected as part of this study can be provided for use in pre-clinical research, process development, process validation, device validation, and further manufacturing into clinical products.

Subjects are prescreened for evidence of transfusion-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.

Targeted Volumes

The standard targeted processed blood volumes are 10 liters, 12.5L, or 15L; however, actual processed volume may occasionally be lower than targeted 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 plerixafor, which may be independent of the dose administered and the volume of blood processed during the collections. A comparison of CD34+ mobilization and yields in G-CSF alone and G-CSF plus plerixafor mobilized products is found here.

Collection Devices

• Terumo BCT Spectra Optia^®
• Fenwal Amicus Separator

Collection Schedule

Products are generally 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. Customers may 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. First collected product can be shipped on the day of collection or held for shipment with the second product on the following day. In some locations, same day delivery is possible. 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 a 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 reduced 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 Plus Plerixafor Mobilized Normal Subjects (Key Biologics' IRB-Approved Protocol), Active Since 2019

Key Biologics' (A Cellero Company) is conducting a research study to evaluate the impact of combining G-CSF along with plerixafor for stem cell mobilization on normal subjects including assessment of the quality of collected products. The protocol includes 6 days of G-CSF injections, 1 injection of plerixafor, and 2 leukaphereses.

• G-CSF ~10µg/kilogram body weight X daily for 5 days
• First product collected on day 5 of injections, approximately 2 hours post G-CSF injection
• Plerixafor ~24ug/kg injection same day
• Second product collected on day 6, approximately 2 hours post last G-CSF injection

Products collected as part of this study can be provided for use in pre-clinical research, process development, process validation, device validation, and further manufacturing into clinical products.

Subjects are prescreened for evidence of transfusion-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 can be performed on each collection if needed. Testing for exposure to Babesia microti is performed for donors in selected geographic regions in accordance with FDA recommendations.

Targeted Volumes

The standard targeted processed blood volumes are 10 liters, 12.5L, or 15L; however, actual processed volume may occasionally be lower than targeted 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 and plerixafor, which may be independent of the dose administered and the volume of blood processed during the collections. A comparison of CD34+ mobilization and yields in collected products is found here.

Collection Devices

• Spectra Optia^®
• Fenwal Amicus Separator

G-CSF mobilization is routinely performed using a filgrastim biosimilar. Customers may specify which filgrastim biosimilar is used, if preferred, or request filgrastim.

Collection Schedule

Products are generally 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. Customers may 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. First collected product can be shipped on the day of collection or held for shipment with the second product on the following day. In some locations, same day delivery is possible. 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 a 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 reduced shipment times. With the latter option, transport times to Europe and Australia are less than 36 hours from end of collection to product receipt.

Mobilized Normal Subjects Collected Under Sponsor’s IRB-Approved Study

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 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 for Key Biologics’ protocol submission and management through 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 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 use that prohibit 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. If needed, additional disease testing, e.g., EBV, HAV, parvovirus, HHV, etc. can be performed. 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

Mobilization is routinely performed using a filgrastim biosimilar; however, if required by the Sponsor's protocol, filgrastim will be used. Plerixafor alone or in combination with G-CSF may 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. In some locations, same day delivery is possible. 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.