NutraBio's Questions and Answers

The following holds true for all raw materials received into NutraBio’s manufacturing facility as per FDA Title 21 CFR Part 111. NutraBio is a GMP facility registered and inspected by the FDA under this regulation:

1. Each raw material manufacturer must be qualified annually by NutraBio prior to ordering a raw material. The process adheres to FDA CFR 11 guidelines for vendor qualification and includes among many other steps third party independent verification of manufactures certificate of analysis.
2. A certificate of analysis (COA) must be supplied by the manufacturer with each lot we purchase; this COA must be lot specific and must accompany each lot as it is received into our facility. Any raw material delivered to our facility without an attached COA is automatically rejected and returned to the manufacturer. Per our Vendor Qualification GMP SOP, the manufacturer’s COA must be verified and qualified through 3rd party analysis. Any raw material that fails analysis remains in quarantine until returned to the manufacturer.
3. Upon receipt of raw material into our facility it is quarantined until released by our in-house quality control lab headed by our PHD chemist. Samples of each lot are taken. Our lab tests each sample to verify identity of the raw material through chemical analysis. If the raw material passes it is released by our lab for use in production, if the test fails it remains in quarantine until returned to manufacturer.

I love this question, because there is so much confusion about denaturization in the industry. Proteins within living cells have specific activities. If the protein is altered then its activity within the cell is altered which can disrupt the cell or cause cell death. This is not relevant with regards to protein supplementation for the following reason. 

Denaturization can alter the protein fractions but it will not alter the base amino acids that make up the protein. Our bodies do not use the protein fractions in milk; they break these fractions down into the individual base amino acids and then rebuild these amino acids into any of thousands of proteins that the body requires. So the fact that denaturing a protein alters or destroys the protein fractions within the milk is true, so what, as long as the amino acids remain intact, the end value to the body remains the same.

But don’t run out and buy denatured whey so quickly. There is another question to consider. If denaturization alters the protein structure, can this affect the bioavailability of the protein? We know that whey isolate breaks down quickly whereas casein breaks down slower, so we use each for different purposes. If denaturization unknowingly changes their bioavailability characteristics, than our supplementation strategies won’t work.

Acid treatment and high heat are both known catalysts for denaturization and unfortunately we don’t know the affects eithe has on bioavailability because it has never been studied. The standard used for protein digestibility studies is non-acid treated, pasteurized whey which gives us a foundation on which we can build a sound supplement strategy. Changing protein structures without knowing the end result can impact results for better or worse, but since we don’t know, don’t chance it.