Human Serum and Plasma

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Human Serum and Plasma

BioPlasma


Plasma is the pale yellow liquid portion of human blood. The primary purpose of plasma is to transport nutrients, hormones, and proteins and remove waste products from other cells. Plasma also provides the matrix for movement of all cellular (RBC, WBC, Platelets) elements of blood through the circulatory system.


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Overview

Human Plasma samples and products are manufactured in a closed system by placing the whole blood units in a calibrated centrifuge. High RPM centrifugal force causes heavier cellular components to the bottom of the bag and the plasma with a density of 1.025 g/dl remains at the top of the centrifuged unit. Plasma provides the matrix that allows cellular blood component's to circulate through the vascular system. Water makes up greater than 90% of the volume of plasma, while dissolved proteins such as albumin, antibodies and fibrinogen make up 6-8% of the volume. Plasma also contains electrolytes, clotting factors, hormones and carbon dioxide excreted during cellular respiration. The viability of coagulation factors in plasma is affected by the elapsed time between phlebotomy and freezing and the elapsed time after thawing.

Fresh Frozen Plasma is separated within 8 hours after phlebotomy and frozen to -18°C. After thawing, the Factor VIII activity is ≈ 107%, Factor II activity is ≈ 81%, Factor V activity is ≈ 79%, Factor VII activity is ≈ 90%, Factor X activity is ≈ 85%, and the fibrinogen content is ≈ 225 mg/dl. After having been thawed between 24-48 hours, the Factor VIII activity is significantly reduced. Other coagulation factors are relatively unchanged up to five days after thawing. Plasma can also be prepared with the cryoglobulin fraction (concentrated Factor VIII, Factor XIII, von Willibrand Factor, Fibronectin, and Fibrinogen) removed and the product refrozen.

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BASIC REQUIREMENTS


Intention of Use
N/A RUO Clinical

Regulatory Status
N/A IRB NDA BLA

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

Cell Type
N/A Serum Plasma

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

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

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




ADDITIONAL PROCESSING REQUESTS


Processing
N/A Aliquoted Irradiated Freeze WBC Reduced

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

Anticoagulant
N/A CPD CP2D ACD Heparin Citrate

Containing Known Antibody - RBC Antibodies
N/A Anti-C Anti-D Anti-c Anti-e Anti-f Anti-M Anti-N Anti-S Anti-s Anti-U Anti-K Anti-k

Anti-Kpa Anti-Kpb Anti-Jsa Anti-Jsb Anti-FYa Anti-FYb Anti-Jka Anti-Jkb Anti-Lua Anti-Lub Anti-P Anti-P1 Anti-Pk

Anti-PP1pk Anti-Lea Anti-Leb




DONOR SPECIFICATIONS


Gender
N/A Female Only Male Only Both

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

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

Preparation
N/A Steroid Mobilization Fasting GCSF Mobilization

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

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

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

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

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 2 Diabetes Type 1 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 Crohn's Irritable Bowel GERD Ulcer Reflux Ulcerative Colitis

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

Ophthalmic Disease
N/A Blindness Cataracts 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.