Human Red Blood Cells

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Human Red Blood Cells

BioCell


Red Blood Cells (RBC) transport oxygen to tissues and deliver CO2 from the tissues to the lungs. These hemoglobin filled cells are 8-10 microns in size, have no nucleus, cytoplasmic structures or other organelles. The bi-concave disc shape provides the pliability needed to allow the cell to move through 3 micron capillary spaces. The RBC cell wall is a phospholipid bilayer containing many antigenic structures that make up blood types and groups.


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Overview

Human Red Blood Cell samples and products are manufactured in a closed system by placing the whole blood units in a calibrated centrifuge or using apheresis technology. High RPM centrifugal force causes the heavier red blood cells to concentrate in the bottom of the collection system. After centrifugation, plasma is pushed from the RBC product to another bag integrally connected to the collection bag. From a whole blood collection, a portion of the Citrate-Phosphate-Dextrose (CPD ≈ 26.3 g/L tri-sodium citrate, 3.7 g/L citric acid, 2.22 g/L monobasic sodium phosphate, 25.5 g/L dextrose) anticoagulant in the collection bag remains in the RBC product. The hematocrit of the resulting unit is between 65-80%. Apheresis derived RBC’s contain Anticoagulant Citrate-Dextrose Solution, Solution A (ACD-A ≈ 26.3 g/L tri-sodium citrate, 3.7 g/L citric acid, 24.5 g/L dextrose). Depending on customer needs, products can be modified by filtration and addition of preservatives.

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BASIC REQUIREMENTS


Intention of Use
N/A RUO Clinical

Collection Method
N/A Phlebotomy Apheresis

Regulatory Status
N/A IRB NDA BLA

Anticoagulant
N/A CPD CP2D ACD Heparin Citrate

Volume
N/A 5ml 10ml 25ml 50ml 100ml 200ml

Storage And Transport Temperature
N/A 1-10 °C 20-24 °C -18 °C -80 °C

Per Week Demand
N/A 1-2 3-5 5-10 20-30 40-50 100 Greater than 100

Duration of Order
N/A 1-3 Months 4-6 Months 12 Months 24 Months Greater than 24 Months

Age of cells
N/A 1-5 days 42 days 0-1 Year More than 1 Year




ADDITIONAL PROCESSING REQUESTS


Processing
N/A Aliquoted Irradiated Freeze Wash Volume Reduced WBC Reduced

HLA Typing
N/A Low Res Class 1 Low Res Class 2 High Res Class 1 High Res Class 2

Additional Testing Requirements
N/A CMV Negative Sickle-Trait Negative Serologic Phenotype DNA Phenotype

Phenotype Requirements
N/A D+ D- C+ C- c+ c- E+ E- e+ e- M+ M-

N+ N- S+ S- s+ s- U+ U- K+ K- k+ k- Kpa+

Kpa- Kpb+ Kpb- FYa+ FYa- FYb+ FYb- Jka+ Jka- Jkb+ Jkb- Lua+ Lua-

Lub+ Lub- P+ P- P1+ P1- Xga+ Xga-




DONOR SPECIFICATIONS


Gender
N/A Male Only Female Only Both

Age
N/A 18-40 50-65 Older than 65

Preparation
N/A Fasting Steroid Mobilization GCSF Mobilization

Ethnicity
N/A African American Caucasian Native American Hispanic Asian Native Hawaiian or Pacific Islander

Blood Group / Type
N/A A+ A- B+ B- AB+ AB- O+ O- RBC Phenotype

Criteria
N/A 21 CFR 600 21 CFR 1271 FACT HRSA-OPTN AABB

Infectious Disease Test Positive
N/A HIV 1/2 HIV NAT HCV Antibody HCV NAT HBV Antibody HBV NAT WNV NAT Chagas Antibody Zika NAT CMV Antibody Syphilis Antibody

Abnormal Laboratory Test
N/A Total Cholesterol HDL LDL ALT AST PSA A1c T4 TSH Pap Smear

Medications
N/A Have Not Taken Have Taken Cardiovascular Antiarrhythmic Penicillins Cephalosporins Sulfonamides Tetracyclines Antihypertensives Anticonvulsants Analgesics Sedatives Anticoagulants

GI Agents Hormones Immunologic Metabolic Psychotherapeutic Respiratory Contraceptives

Cardiovascular Disease
N/A High Blood Pressure Congestive Heart Failure Coronary Artery Disease Angina Arrhythmia Stroke

Endocrine Disease
N/A Diabetes Type 1 Diabetes Type 2 Hypothyroidism Hyperthyroidism Hashimoto's Thyroiditis

Gynecological / Urological Disease
N/A Chronic UTI Kidney Stones Renal Insufficiency

Hematological Disease
N/A Hemophilia Sickle Cell Anemia TTP Lymphoma Leukemia

Oncological Disease
N/A Prostate Breast Cervical Liver Lung Melanoma

Pulmonary Disease
N/A COPD Asthma Cystic Fibrosis Emphysema Tuberculosis

Autoimmune Disease
N/A Addison's Rheumatoid Arthritis Chronic Thyroiditis Celiac Sjögren's Lupus Graves Scleroderma

Digestive Disease
N/A Crohn's Irritable Bowel GERD Ulcer Reflux Ulcerative Colitis

Neurological Disease
N/A Seizures Alzheimer's Multiple Sclerosis‎ Migraines

Ophthalmic Disease
N/A Cataracts Blindness Glaucoma Uveitis

COLLECT:

Custom collections from a pool of thousands of healthy donors.

CHARACTERIZE:

Flowcytometry characterization of immune cells.

ISOLATE:

Research or GMP grade positive or negative cell selection procedures.

EXPAND:

Flask or automated expansion services.

FREEZE:

Controlled rate freezing using custom cryo-preservatives.

STORE:

Monitored LN2 vapor phase storage of products and samples.