Non–Mobilized Normal Subjects (Key Biologics' Proprietary Protocol – IRB–Approved), Active Since 2010

Key Biologics' (A Cellero Company) collects mononuclear cell (MNC) products under an IRB-approved protocol from normal healthy individuals 18 to 65 years of age and qualified in accordance with current regulations and requirements for donors of transfusable blood components. This includes 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 transfusable blood components. Additional health history questions used to screen donors of cells and tissue for transplantation are also included.

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 subject safety requirements and IRB-approved 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 two weeks and up to 24 times in any 12-month period.

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.

Subjects with Hematologic Malignancies (Key Biologics' Proprietary Protocol – IRB Approved)

It has been shown that MNCs collected from persons diagnosed with hematologic malignancies have characteristics and responses to immune stimulation that differ from MNCs collected from normal healthy individuals. Therefore, MNCs collected from patients diagnosed with the targeted malignancy are a more ideal raw material for research and development of autologous immuno-oncologic agents.

The protocol allows collection of MNCs from individuals diagnosed with one of the following hematologic malignancies:

• Chronic Lymphocytic Leukemia
• Multiple Myeloma
• Non-Hodgkin Lymphoma
• Acute Lymphocytic Leukemia

Under either of the above protocols, products can be collected on one of two devices as preferred by the customer:

• Terumo BCT Spectra Optia^®
• Fenwal Amicus Separator

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. Processed volume for collections under the hematology malignancy protocol is limited to 10L or less.

Standard final product volume is approximately 200mL for 10L, 12.5L, and 15L processing volume products. Standard product volume is approximately 100mL for 5L and 7.5L processing volume products. 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/transport media, e.g., HypoThermosol (BioLife Solutions), may be added if requested.

Specific normal subjects may be selected from our database based on:

• Blood type
• Age
• BMI
• Gender
• Ethnicity
• Human Leukocyte Antigen phenotype
• Natural Killer Cell Immunoglobulin-like Receptor (KIR) typing

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

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. Options exist for a customer to request either a morning or evening collection if there are concerns about transit time from the end of collection until arrival for processing. Multiple collections for a single customer can be performed on the same day.

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. 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 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' (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.

Products can be collected on one of two devices or paired collections can be performed on both platforms for product comparisons if preferred by the customer:

• 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.

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. 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 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.