100% Donor Animal Facility

Quad Five is a leading producer of medical-grade animal blood and serum products for use by medical centers, laboratories, universities, and pharmaceutical companies across the globe. We are the only biological producer in the U.S. to harvest 100% of our blood from donor animals, not animals bound for slaughter.

Blood, as a biological fluid, can be adversely affected by many different parameters, including age, genetics, diet, health, and environment of the source animal. Quad Five has developed a proprietary donor animal program to control these issues, ensuring the highest quality and consistency. Our commitment to providing top medical-grade products is in lockstep with our commitment to the quality treatment and care of our donor animals. At Quad Five, integrity and sustainability go hand-in-hand.

Donor Animal Protocols

  • Sheep, horses, bovine, and goats are selected specifically for their fitness and use as blood donors.
  • The animals are located at our USDA-inspected facility where our animal experts have complete control of their care, diet, and health. As a result, we do not experience problems associated with slaughter animals such as:
    • Antibiotics
    • Animal source protein feed supplements
    • Hemolysis (cell fragility) due to the diet fed to animals prior to slaughter
  • Animals are bled in a cyclic rotation to recover cell volume (hematocrit).

Blood Protocols

Harvesting

All Quad Five defibrinated sheep, horse, bovine, and goat blood, as well as blood products in anticoagulants, are produced “just in time” specifically for your order. These products are collected and processed within 12-48 hours of shipment to provide the highest quality possible.

While we do not maintain shelf stock, we are typically able to offer same-day shipping on small orders received by 10 a.m.

Processing

All sheep, horse, bovine, and goat blood is collected, processed and distributed from our Montana facility. In addition to defibrinated blood – citrated, alsevers, laked, lysed and washed red blood cell products are available.

Custom blood preparations are made to order in a variety of buffers or anticoagulants.

Sterility

Defibrinated blood and blood with anticoagulant are aseptically collected in sterile bags, pooled through a sterile disposable manifold and packaged into sterile final containers.

Blood must be drawn, processed, and used aseptically as there are no methods of sterilization, given the presence of cells. In addition, the relatively short shelf life of the cells precludes these products from 21-day USP testing. We recommend storage at 2 to 8 degrees C and the use of these products as soon as possible. Testing reports stating sterility results will be provided upon request following receipt of the blood.

After more than 2 million liters and more than 33 years, we are very confident in our processes and procedures. Quad Five warrants the suitability of these products for culture media. In the event there is any problem, the blood product will be replaced.

BLOOD AND SERUM PRODUCTS

Serum Protocol

Traceability

To produce the highest quality, performance-consistent serum on the market, Quad Five meticulously controls all aspects of the blood acquisition process:

  • Animal Acquisition
  • Quarantine
  • Diagnostic Testing
  • Collection
  • Processing
  • Sterile Filtration
  • Product Testing and Release

Collection

Sheep, horses, bovine, and goats occupy separate parcels of the 9,000-acre ranch and are cared for by staff trained in modern ranching practices. Each animal group has its own dedicated collection center. Blood is collected by venipuncture into sterile containers under vacuum. Individual animal collections records follow through to the final batch file.

Processing

Serum is processed from whole blood under cGMPs. Following refrigerated centrifugation, it is immediately frozen at -20° C for testing prior to filtration.

Filtration

Upon raw product release, day lots are quickly thawed and then pooled at 4°C. Filtration is scaled by lot volume (typically 600 liters) and serum type / species. Filtration consists of a train of prefilters followed by one .2um nominal filter and one .2um absolute rated pharmaceutical grade filter. The filling of final containers is done under Class 100 conditions.

Packaging

PETG square media bottles

3 liter F style containers

Quality Testing

All donor sera lots must meet the following specifications to be released by quality assurance:

Endotoxin <0.125 EU/ml Limulus Amebocyte Lysate (LAL) qualitative
Hemoglobin <15 mg/dl Photometrically (Fleming & Woolf)
Mycoplasma None detected Large volume (Barile)
Bacteria & Fungi No Growth USP Title XXIII/CFR Title 9 Part 113.26
pH 7.0 – 8.5 pH meter

Application

Our serum products are used in a diverse range of research and industrial applications including microbiological culture media, diagnostic kits, tissue culture, and vaccine manufacture.

Sample Testing

100ml samples and Certificates of Analysis are provided at no charge for your evaluation. For end users with highly specific or difficult applications, we will provide samples from more than one lot for concurrent testing if inventory reserves permit.

Serum Reserve Policy

Upon sample request, a reserve will be placed on the sampled lot for the volume required.

Customers will have 30 days after receipt of the sample for testing, unless other arrangements are made at the time the sample is shipped.

Quad Five will hold an accepted reserve at no charge with price protection for up to 12 months. A purchase order, including a shipping schedule, is required. Reserves are monitored and users will be contacted about new samples when reserve inventories are low, or the last shipment has been made.

Improving Health. Improving Life.