Blood Protocol

The collection and use of animal blood in microbiology dates back to the earliest preparations of culture media. Blood, as a biological fluid, can be affected by different parameters, including the age, genetics, diet, health, and environment of its source.

Quad Five has worked for 27 years to develop and maintain a donor animal program that controls these issues as they relate to the quality and consistency of our sheep blood, horse blood, bovine blood, and goat blood products.

All Quad Five defibrinated sheep blood, horse blood, bovine blood, and goat blood, as well as blood products in anticoagulants, are produced "just in time" specifically for your order. To provide the highest quality possible, these products are collected and processed within 12-48 hours of shipment. While we do not maintain shelf stock, we typically are able to ship small orders received by 10:00 a.m. the same day.

If you manufacture microbiological culture media, we believe you will find our blood products to be the best available.

Source

1. Sheep, horses, cattle, and goats are located at our USDA facility specifically for their fitness and use as blood donors.

2. Animals are bled in a cyclic rotation in order to recover cell volume (hematocrit).

3. Because Quad Five has true donor animals bled on an ongoing basis, we have complete control of their care, diet and health. Consequently, we do not have some of the questions or problems associated with other blood sources:

i) Antibiotics?
ii) Animal source protein feed supplements?
iii) Hemolysis (cell fragility) due to the diet fed to animals prior to slaughter.

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 faxed upon request following receipt of the blood.

After more than 2 million liters, over 27 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.

Serum Protocol

Traceability

In order to produce the most consistent and documented serum available, Quad Five controls all aspects of the process:

  • animal acquisition
  • quarantine
  • diagnostic testing
  • collection
  • processing
  • sterile filtration
  • product testing and release

Collection

Sheep, horses, cattle, and goats are held in separate areas of the 5,555 acre facility with dedicated collection centers. Blood is collected by venipuncture into sterile containers under vacuum. Individual animal collection 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 0.2um nominal filter and one 0.2um 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.

 

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