PBMC PRODUCTS "LEUKOPACKS"

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PBMC PRODUCTS "LEUKOPACKS"

BioCell


Peripheral Blood Mononuclear Cell (PBMC) apheresis products, often called “Leukopaks” are collected from a single donor using apheresis systems. These products are enriched sources of monocytes and lymphocytes. They also contain platelets, plasma, and red cells. Leukopaks are for research or clinical use.


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Overview

Standard PBMC apheresis product is collected from a non-mobilized donor using automated apheresis. ACD anticoagulant is used at a ratio of 1:13, with a guarantee of at least 1.8 billion cells per product. However, PBMC product may be collected to the specifications of the customer, such as a target number of cells or blood volume processed. In addition, if unique donor characteristics are specified, we are positioned to recruit the type of donors needed. Post-collection processing, cell population characterization, cell type isolation, and cryopreservation are additional services available upon request.

Technical Description PDF

To specify target specifications, demand frequency, storage and shipping temperature, donor characteristics, additional processing, or testing needs, click on “Customize” tab.

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BASIC REQUIREMENTS


Intention of Use
N/A RUO cGMP

Regulatory Status
N/A IRB NDA BLA

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

Anticoagulant
N/A CPD

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 10-30 30-50 50-100 >100

Duration of Order
N/A 1-3 Months 3-6 Months 6-12 Months 12-24 Months >24 Months




ADDITIONAL PROCESSING REQUESTS


Processing
N/A HPC Reduced T-Cell Reduced Volume Reduced WBC Reduced Expansion Wash Aliquoted Freeze Irradiated

Lymphoid Enumeration
N/A CD3+ CD4+ CD8+ CD14+ CD16+ CD19+ HLA A2+

Viability
N/A 7-AAD Assay CFU Assay (CD34+, CD45+)

Mesenchymal Enumeration
N/A CD14+ CD34- CD45- CD90+ CD73+ CD105+ HLA DR-

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

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




DONOR SPECIFICATIONS


Gender
N/A Male Female Both

Age
N/A 18-40 40-65 >65

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

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

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

Medications
Have Not Taken N/A Anticonvulsants Have Taken Metabolic Penicillins Hormones Antihypertensives Immunologic Analgesics Contraceptives Tetracyclines GI Agents

Cephalosporins Sulfonamides Antiarrhythmic Psychotherapeutic Cardiovascular Anticoagulants Respiratory Sedatives

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

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

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

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

Hematological Diease
N/A Leukemia Lymphoma Anemia Hemophila TTP Sickle Cell

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

Oncological Disease
N/A Lung Prostate Liver Cervical Breast Melanoma

Pulmonary Disease
N/A Asthma Cystic Fibrosis Emphysema COPD Tuberculosis

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

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

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

Ophthalmic Disease
N/A Glaucoma Blindness Cataracts 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.