Product Testing And Quality Control

Our quality control programs are comprehensive, from the donor cow to delivery of the finished product. Our product is extensively tested to ensure that it meets the highest standards for purity, potency, safety, and efficacy.

Purity

  • Every batch of product is sent to an independent laboratory for microbial testing both before and after packaging. Before approval for sale, each product must be shown to be totally free of potentially pathogenic organisms, including E. coli (coliforms) and Salmonella. Ever batch of product we have made since 1995 was culture negative for Mycobacterium avium subspecies paratuberculosis (MAP), the cause of Johne's Disease.

 

Potency

  • Since the immune globulins (Igs) are the most important immune molecules naturally found in colostrum, potency is based on measuring the concentration of IgG. The most accurate and reliable way of measuring IgG is by using a laboratory test called radial immnuodiffusion (RID) assay. We use an RID that is standardized using a reference reagent provided by the USDA. This ensures that our RID is always tested against a standard reagent that does not change over time, and provides highly accurate and reliable results.
  • Within each grade of our colostrum, protein, fat, lactose, and energy levels show little variation from batch to batch. The level of key vitamins and minerals have also been tested.
  • We have also measured the concentration of important antimicrobial factors, including lactoferrin, lactoperoxidase, and lysozyme.
  • We measure the level of key growth factors, such as insulin-like growth factors 1 and 2 and epidermal growth factor, on an as needed basis.
  • When requested by customers, we measure other important components, such as trypsin inhibitor.

 

Safety

  • To test for safety, we feed each batch of final packaged product to calves at the recommended dosage and then observe them to be sure there are no toxic or adverse effects. This ensures that there is no health or toxicity risk. We have never had a batch cause an adverse reaction in calves or fail this safety test.     

  

Efficacy

  • Efficacy testing is done to confirm that each batch of product meets the therapeutic specifications set for it. This is based on demonstrating that recipients have therapeutic levels of bioactive IgG in their blood after being fed the product. We conduct efficacy testing on final packaged product by feeding it to newborn, colostrum deprived calves at the recommended dose, and then taking a blood sample a day after feeding. The level of IgG in the calves’ blood is then measured by RID to be sure that it has reached target therapeutic levels. If it has, this confirms that the product will be effective under field conditions if administered according to package instructions.


In addition to our internal QC testing, we are required to send our test results and samples of CFIA and USDA licensed products to those government agencies for additional testing in their laboratories at their discretion prior to sale. This adds an additional level of independent assessment which many farmers and veterinarians have come to rely on.

Even further, government-approved (CFIA and USDA) safety and efficacy studies, as well as trials done by independent investigators, confirm the superior quality and performance of our products.





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