Assessing an individual’s eligibility to safely donate blood products has always been and remains our highest priority. To accomplish this, we use a several stepped process, learn more about our process below.
Key Biologics (A Cellero Company) has transitioned over the past two plus decades from a department within an FDA-registered community blood center providing FDA-licensed biologics, e.g. transfusable blood components, into a for-profit corporate entity providing biologics used as raw materials for manufacturing first-in-human therapeutics around the world. However, our core commitment to the care of individuals who provide the biological raw material we collect has not diminished but has increased in scope.
Assessment of an individual’s eligibility to safely donate a blood product remains our highest priority. To accomplish this, we use a several stepped process. We have consistently used an extensive health history questionnaire modeled on those required for screening donors of transfusable blood components. The AABB has prepared questionnaires for this purpose and submitted them to the FDA for review and approval for use over the last two decades. The current version of the Donor Health Questionnaire (DHQ) is version 2.0 and we use that in toto. Additionally, the AABB has prepared a version for screening tissue donors that includes more specific questions designed to detect exposure risk of transplanted tissues and organs. We also incorporate several questions from the questionnaire that are pertinent for customers who use our supplied products for production of clinical grade materials. The AABB and FDA periodically release guidance for management of emerging relevant transfusion-transmitted infections (RTTIs) prior to specific changes in the DHQ or applicable standards. Key consistently adheres to these requirements and implements additional measures as soon as possible to mirror actions taken by community blood centers. Recent examples of these early actions include questions and subject educational materials to screen for exposure/infection with babesia sp., ZIKA virus, and most recently the SARS-CoV-2 virus causing the current COVID pandemic. As a final assessment for eligibility to participate in our protocols we use a Supplemental Health Questionnaire to screen all subjects following enrollment. This allows us to ascertain more information about the subject’s history and his/her immediate family history to allow assessment of eligibility for continuation in the study.
The second step in assessing the individual’s suitability to undergo a blood product collection includes a mini-physical exam to determine state of health as manifested by standard vital signs, to include temperature, pulse rate and rhythm, and blood pressure. Parameters for acceptance are in place for all these markers. Additionally, we collect a blood sample for performing a complete blood count (CBC) with 5-part differential to allow assessment of the subject’s hemoglobin, hematocrit, platelet count, total white blood cell and total lymphocyte count along with red blood cell indices. Where applicable, the acceptable ranges for many of these parameters comply with AABB Standards and FDA requirements. For others not included in the Standards or FDA requirements, our protocols include acceptable parameters in the Inclusion/Exclusion criteria. Post collection of all our leukapheresis products, another CBC is performed on the subject’s blood to assess the impact of the collection on his/her counts, especially the platelet count. We use those results to guide additional assessment of the subject as warranted. The collected product is also assessed with a CBC and 5-part differential to asses quality and collection efficiency.
The last screening step is testing for exposure to RTTIs by use of the standard panel of infectious disease tests required by the FDA for testing blood intended for transfusion. We have consistently used this full panel of tests for both assessment of a subject’s eligibility to continue in a protocol following enrollment and to screen every collected blood component. All testing is performed in CLIA licensed laboratories using tests approved by the FDA for transfusion screening. As new tests are approved and introduced, they are added to our testing panel as soon as they are available. Additionally, when an opportunity exists to participate in an investigational new device (IND) trial for a new test to allow early access to testing, we have and will continue to do so. The most recent example being testing for the ZIKA virus under an IND. Testing at two levels of sensitivity is available for Hepatitis B and C viruses (HBV, HCV), Human Immunodeficiency Virus (HIV), and Zika Virus; a standard level used for blood transfusion that uses pooled-sample testing for NAT assays for viral DNA or RNA, and a “tissue-level’ that uses single donor samples for these assays. The latter is more sensitive and is required for cadaveric donor screening but is used by some customers who use collected raw material for manufacturing clinical-grade products. Its use allows a higher level of certainty that the donor is not infectious for these agents. We offer two additional screening steps to customers that want a higher level of assurance that the donor is not exposed to RTTIs at the time of collection. First is repeat IDT testing at a time point between 30- and 90-days post-collection and product shipment. The second is processing the product for frozen storage on site at our facility and then performing the repeat testing as described above, but only releasing the product based on the ‘delayed release’ panel results. This option provides the highest level of assurance the donor of the raw materials has not been exposed and infected by one of the agents included in the IDT panel.