Platelets

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Platelets

BioCell


Platelet products are either manufactured from: apheresis collections, also known as single donor platelets (SDP), platelet apheresis or apheresis platelets; or whole blood derived platelet concentrates. Five units of whole blood derived platelet concentrates are pooled together to make a therapeutic platelet dose. All platelet products are tested for bacterial contamination using a culture system. HLA matched or cross matched platelets may be needed to treat patients with post-transfusion platelet refractoriness, when their platelet count does not adequately rise after a platelet transfusion due to HLA and/or platelet antibodies.


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Overview

Platelet concentrates can be prepared from whole blood units or from apheresis devices. Whole blood-derived platelets are prepared by using low RPM centrifugation to separate the platelet-rich plasma (PRP) from the red blood cells. The PRP component is transferred to another bag and then exposed to high RPM centrifugation to create a platelet pellet in the bottom of the component bag. Using a small volume of plasma, the pellet is re-suspended and stored at room temperature for up to 5 days post collection. Each of these units contain approximately 5.5 X 1010 platelets. Platelet units include some WBC’s, 50 mL of plasma and a few RBC’s (Hct less than 0.005%). The PRP method of production is common in North America, but other counties us the Buffy Coat method to produce these products.

Apheresis derived platelets are prepared using an automated process where blood is drawn from the donor into an apheresis instrument which separates the blood into its components, retains some of the platelets, and returns the remainder of the blood to the donor. This single donor platelet product contains about four to six times as many platelets as a unit of platelets obtained from whole blood. Units are available as <1.5 X 1011, 1.5-3.0 X 1011, or > 3.0 X 1011 platelets/unit. Each unit contains approximately 300 mL of plasma, a few WBCs (< 5 X 106) and trace amounts of RBCs.

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BASIC REQUIREMENTS


Intention of Use
N/A RUO Clinical

Regulatory Status
N/A IRB NDA BLA

Collection Method
N/A Phlebotobmy Apheresis

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

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

Cell Yield Target
N/A 1E6 3E6 1E9 3E9 5E9

Age of Cells
N/A Fresh In-Date Expired




ADDITIONAL PROCESSING REQUESTS


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

Anticoagulant
N/A ACD




DONOR SPECIFICATIONS


Gender
N/A Male Only Female Only Both

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

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

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

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

Preparation
N/A Fasting Steroid Mobilization GCSF Mobilization

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

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 HDL Total Cholesterol LDL ALT AST PSA A1c T4 TSH Pap Smear

Cardiovascular Disease
N/A Congestive Heart Failure High Blood Pressure 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 Sickle Cell Hemophilia Anemia TTP Lymphoma Leukemia

Oncological Disease
N/A Prostate Breast Cervical Liver Lung Melanoma

Pulmonary Disease
N/A Asthma COPD Cystic Fibrosis Emphysema Tuberculosis

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

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

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

Ophthalmic Disease
N/A Blindness Cataracts 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.