Frequently Asked Questions

What kind of tests are conducted to screen donors for communicable disease?

To prescreen subjects for evidence of transmissible infectious diseases, Key Biologics uses the standard panel of tests used to screen blood products for transfusion acceptability.

• Hepatitis B virus surface antigen (HBS)
• (Total) Antibody to hepatitis B virus core antigen (HBC)
• Hepatitis C virus antibody (version 3.0) (HCV)
• Human T-cell Lymphotropic Virus type I and II antibody (HTL)
• Human Immunodeficiency Virus type 1 and 2 antibody (HIV)
• Nucleic Acid Technology testing to detect Hepatitis C virus RNA and Human Immunodeficiency virus RNA (NAT)
• Nucleic Acid Technology testing to detect West Nile virus RNA (WNV)
• Serologic test for syphilis (STS)
• Trypanosoma cruzi antibody (Chagas disease agent) (CHG) is performed on all subjects, but is not repeated with each collection.
• (Total) Cytomegalovirus antibody (CMV) can be performed, but is optional

In addition the subject’s blood is tested to determine ABO type and to screen for unexpected antibodies against red cell antigens. Presence of these antibodies does not routinely preclude a subject from providing a blood product; however, the subject’s eligibility is at the customer’s discretion.

The subject can also be prescreened for anti-HLA Class I and Class II antibodies and accepted or rejected at the customer’s discretion.

Which mobilization regimen is better for those looking to obtain CD34⁺ cells?

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, two mobilization options are available:

• Short-course: 10µg/kilogram body weight X 3 days, single collection on day 4

• Long course: 5µg/kilogram body weight X 5 days, 2 collections, one on day 5 and one on day 6

Products are collected on the COBE^® Spectra collection system using either the MNC or AutoPBSC^® collection protocol and disposable software. The standard processed blood volumes are 10 liters, 12.5L or 15L. The data collected to-date suggests the "long course" is optimal for the collection of CD34⁺ cells as CD34⁺ cells peak on about day 6 of G-CSF injections (Stroncek, Transfusion, 1996; 36:601-610).

What options are available for international shipments?

Key Biologics has extensive experience in shipment of products internationally including management of customs-related issues. We work with the customer to define the shipping requirements and help the customer select the carrier option that works best.

For shipments into Canada, many customers select World Courier. For shipments into Europe, UPS or FedEx are excellent options.

Fresh cellular products are routinely shipped into Europe and arrive within 36 hours of collection with no significant reduction in viability. For shipments into other international destinations, we will review and suggest appropriate options.