Research Products & Services (RPS)

A. Types of draws / blood collections:

Whole Blood:

• 500mL whole blood collected in CPD anticoagulant plus AS-1 Red Cell Additive
• 500mL whole blood collected in CPDA-1
• 450mL whole blood collected without anticoagulant, for production of serum

Apheresis:

• Single donor platelets
• Concurrent plasma by apheresis
• Concurrent red cell by apheresis with AS-3 Red Cell Additive Solution
• Double red cells by apheresis (Trima or Haemonetics) with AS-3 Red Cell Additive Solution
• Plasmapheresis (plasma only donation on Trima)

Specials Apheresis:

• Leukapheresis for MNC’s (healthy donors)
• Leukapheresis for MNC’s (on donors/patients selected by researcher)
• Leukapheresis for Granulocytes

B. Blood Products Collected by either Whole Blood or Apheresis:

• Whole blood
• Red Blood Cells
• Plasma from either whole blood or apheresis donations
• Serum from whole blood donations
• Platelets only from apheresis
• Cryoprecipitate Singles and Cryoprecipitate Pools (5 single units / pool)
• Buffy Coats (single soft centrifugation, premium 50mL product as source WBC’s)
• LRS-WBC’s (8 – 9mL product as source of WBC’s)

C. “5th Tube” or extra tube collections (we can collect 1 or more extra tubes per each WB donation to provide to researchers):

• EDTA (purple top)
• Clot tube (red top)
• Clot tube with serum separator
• ACD tube (yellow top)
• Heparin tube (green top)
• Citrate tube (blue top)
• Any other special order tube provided by researcher or ordered by SDBB
• Process tubes upon request for added charges (spin, separate, aliquot, freeze)
• Provide small numbers of tubes or large numbers over time
• Collect tubes by race, gender, age, etc
• Provide demographic info at extra cost per item on each tube

D. Testing (for requirements by FDA for donor suitability screening):

• ABO/RH ABO & Rh Blood Groups
• HBsAg Hepatitis B Surface Antigen
• HIV Antibody to Human Immunodeficiency Virus 1 / 2
• HCV Antibody to Hepatitis C Virus
• NAT Nucleic Acid Testing for HIV 1 / HCV
• NAT3 Nucleic Acid Testing for HIV1 / HCV / HBV
• HTLV Antibody to Human T-lymphotropic Virus I and II
• HBC Antibody to Hepatitis B Core
• STS Syphilis Test
• WNV Nucleic Acid Testing for West Nile Virus
• ABS RBC Antibody Screen
• CMV Antibody to Cytomegalovirus
• TCRZ Antibody to Trypanosoma cruzi (Chagas disease)

E. QC lab testing:

• Complete CBC
• CBC with Differential
• WBC counts on leukoreduced blood products
• Use of the flow cytometer (limited use based on validation of protocols, can be expanded)
• Equipment validation (validation writing and execution for centrifuges, refrigerators, freezers, RT incubators, thermometers, scales, temperature monitoring systems, etc)

F. Component Production (cGMP Manufacturing):

• Centrifuges that can be operated at selected refrigerated temperatures or at Room Temperature
• Sterile tubing heat sealing
• Sterile tubing welders or connection devices to attach bags in a closed system
• Cell Washers to perform saline wash of cellular components
• Blast or “flash” freezers for rapid freezing of plasma, serum or other components
• Freezers for -30˚C frozen storage
• Freezers for -80˚C Ultra Cold frozen storage
• Laminar flow hood to provide aseptic work space at the bench
• Dockable leukoreduction filters for RBC’s

G. Reference Laboratory Capabilities

• Full reference laboratory testing service
• Cross-matching
• Antibody identification
• Problem resolution
• Rare RBC unit frozen inventory
• DNA extraction from whole blood and limited PCR testing, currently related to blood typing.

H. Cell Therapy Research

• Harvest, process and store cord bloods
• Ficoll separation of MNC’s.
• Fresh unprocessed cord blood units consented for research use
• Frozen processed cord blood units consented for research use
• Cord blood plasma consented for research use
• IDM, CFU, TNC, CD34 and sterility analyses and testing of cord blood units

I. Clean room/lab facility

• Space available for expansion of research facilities
• Opportunity for incubation of start-up companies conducting blood-based research.

J. Clinical and Regulatory Certifications

• CLIA Certification
• FDA (cGMP) registered facility
• EU certification
• AABB accredited