Cryoprecipitate

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Cryoprecipitate

BioPlasma


Cryoprecipitate is a concentrated blood component made from plasma, usually a cloudy yellow color. It contains specific proteins involved in clotting including: Fibrinogen, Factor VIII (the protein missing in patients with Hemophilia A), Factor XIII and Von Willebrand factor (helps in getting the platelets to stick together).


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Overview

Slowly thawing Fresh Frozen Plasma at 1-6°C creates an environment where higher molecular weight proteins precipitate out of the plasma. Since the precipitation happens in a cold environment the resulting product is commonly called Cryoprecipitate (Cryo); however, the licensed drug name for the product is Cryoprecipitated AHF. This product name was assigned because the drug was developed to provide a high concentration of coagulation factor VIII, also known as anti-hemophilic factor, the factor deficient in Hemophilia A. Cryo is a low purity concentrate of three hemostatic proteins prepared from a single whole blood unit. A single bag of Cryo contains an average of 80 IU of factor VIII and von Willebrand factor and 150 to 250 mg of fibrinogen with some factor XIII and fibronectin. These products can also be sterilely pooled by our facility into larger doses that may be needed for patient care or research needs.

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BASIC REQUIREMENTS


Intention of Use
N/A RUO Clinical

Regulatory Status
N/A IRB NDA BLA

Collection Method
N/A Phlebotomy Apheresis

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

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

Anticoagulant
N/A CPD




ADDITIONAL PROCESSING REQUESTS


Processing
N/A Aliquoted Freeze

Additional Testing Requirements
N/A Sickle-Trait Negative CMV Negative

Preparation
N/A Steroid Mobilization Fasting GCSF Mobilization

Viability
N/A CFU Assay (CD34+,CD45+) High Res Class 2




DONOR SPECIFICATIONS


Gender
N/A Female Only Male Only Both

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

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

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

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

GI Agents Hormones Immunologic Metabolic Psychotherapeutic Respiratory Contraceptives

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

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

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 Sickle Cell Hemophilia Anemia TTP Lymphoma Leukemia

Oncological Disease
N/A Breast Prostate 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 Cataracts Blindness Glaucoma Uveitis

Platelet Antibodies
N/A Anti-HPA-1 Anti-HPA-2 Anti-HPA-3 Anti-HPA-4 Anti-HPA-5 Anti-HPA-6 Anti-HPA-15

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.