Tuesday, December 12, 2017

Mastering the Art and Science of Human Milk Oligosacharide: The Joy of Genetically Engineering HMOs Cookbook

"Glycom has confirmed...that the 2'-FL manufactured by Glycom is chemically and structurally fully identical to the 2'-FL that is present in human breast milk.  Glycom's 2'-FL is therefore referred to as a human identical milk oligosaccharide (HMO)." US FDA Generally Recognized As Safe (GRAS) Notice 650  https://www.fda.gov/downloads/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/ucm513832.pdf


*One host organism, your choice:
E. coli K12 DH1 or Helicobacter pylori

*Genetically modify using knockout genes and inserting a promoter gene.

*Use a plasmid vector from donor strains, Klebsiella pneumonia and Salmonella Typhimurium. Make sure the undesirable genes that are pathogenic or toxigenic are taken out.  The ampicillin and tetracycline resistance genes should not be expressed during fermentation.

*With fermentation the E. coli or H. pylori will express the Human Milk Oligosaccharide, 2'-FL. Use various solvents to extract the pure 2'-FL Human Milk Oligosaccharide such as pyridine, or benzoyl chloride, or DCM, or Methanol. While some of these solvents are highly toxic-unfit for consumption, various processes will be used to make sure none of these solvents remain in the Human Milk Oligosaccharide product.

 *This recipe makes a crystallized powder identical to the Human Milk Oligosaccharide made in the human mammary gland. 

This recipe is my interpretation of the information given in Glycom's GRAS notice 650 to the FDA regarding their 2'-FL Human Milk Oligosaccharide.  My attempt at humor.  Biotech industries use microbes genetically engineered and the process of fermentation to create food products.  Perhaps a cookbook would be somewhat informative for those of us who want to know what is in our food.  

It must be a joke that the FDA has no questions regarding the manufacturing of 2'-FL Human Milk Oligosaccharides.  How could anyone believe that this product is identical to what women produce in their breasts? Glycom "convened" (another word for hired?) an expert panel to critically evaluate their HMO product.  The 4 experts were Dr. Joseph F Borzelleca of the Virginia Commonwealth University School of Medicine, Dr. Ronald Kleinman  of Massachusetts General Hospital for Children, Dr. Robert J Nicolosi of the University of Massachusetts Lowell, and Dr. John A. Thomas of Indiana University School of Medicine.

In 2012 Dr. Joseph F. Borzelleca received a Lifetime Service Award by the International Association of Color Manufacturers. He was responsible for the standards developed in the 70's and 80's for food color safety.
The importance of white color to infant formula is not often recognized. Even though babies do not notice the color of their infant formula, parents notice the color.  I blogged about the use of lutein in baby formulas. http://vwmcclain.blogspot.com/2011/04/lutein-dye-supplement.html

When industry thanks researchers, I get a little uneasy.  Of course this is not about food coloring but whether a genetically engineered food product is safe for babies.

Dr. Ronald E Kleinman of Massachusetts General Hospital is notable.  He is one of the authors of a study that questioned the safety of Baby Friendly Hospitals/exclusive breastfeeding. https://jamanetwork.com/journals/jamapediatrics/article-abstract/2546142?redirect=true 

Interestingly, Massachusetts General Hospital (also known as The General Hospital Corporation) is a co-patent owner to a number of Human Milk Oligosaccharide patents (inventors being David S Newburg, Ardythe Morrow and Gillermo Ruiz-Palacios)

Dr. Ronald E Kleinman has in the past been funded by Mead Johnson and Nestle. He did a study on the optimal duration of breastfeeding which was funded by Gerber.  He also was a paid expert witness for Gerber in a court case.  https://ethicalnag.org/2011/01/27/integrity-in-science-report/

Dr. Robert J Nicolosi is also the Chief Science Officer for a Nanotech company.  Nanotechnology is being used in manufacturing infant formula but not being used as far as I know in the manufacturing of HMO's.

John A. Thomas PhD is or was employed in the Department of Pharmacology and Toxicology as well as a member of the Society of Toxicology since 1971.

Whether the experts convened by Glycom have a lot of expertise in the safety of genetic engineering is unknown.  Perhaps Dr. Robert J Nicolosi with his financial involvement in nanotechnology (not genetic engineering but a newer technology) has a high level of expertise in genetic engineering.  I question whether the other experts have a background in genetic engineering. 

Glycom is a Danish biotechnology company that manufactures HMOs.  Nestle has a strategic stake in Glycom (at least half the BOD are from Nestle).  So I suppose one might just consider Glycom a Nestle company or at least a company with a lot of Nestle influence.

The safety of Glycom's 2'-FL Human Milk Oligosaccharide is based on a clinical trial that was funded by Abbott.  One of the authors of that clinical trial is Rachel Buck who is a listed inventor to many of Abbott's patents on HMO's for use in infant formula.  

The Abbott clinical trial was registered NCT01808105.  The trials were conducted in the USA in various locations and Puerto Rico.

One clinical trial by a company with a vested patented interest in using HMOs seems rather strange to me.  And to declare this HMO identical to the real HMO made by the mammary gland of women seems even stranger.  Yet this is where we are at nowadays.  Deluded, delusional...and these people and institutions determine safety and what products parents believe are being regulated by governmental agencies.  When the formula company advertises their new formula with HMO's identical to human breast milk,  should we laugh or cry?*  
Copyright 2017 Valerie W. McClain

*The label on Abbott's infant formula with HMOs states in small print, "Not from human milk."  Glycom's GRAS statement to the FDA on this particular HMO states that their manufactured HMOs are the same structurally and chemically as real human milk oligosaccharides.