Certiva Online, Description, Chemistry, Ingredients - Certiva - RxList Monographs

Diphtheria toxin is derived from Corynebacterium diphtheriae grown in Stainerís Diphtheria Culture Medium, containing casein hydrolysate, and is purified by fractional precipitation with ammonium sulfate. Tetanus toxin is derived from Clostridium tetani grown in modified Mueller and Miller Medium, containing casein hydrolysate, and is purified by precipitation with ammonium sulfate.2 The purified diphtheria and tetanus toxins are detoxified using formaldehyde.

The diphtheria toxin is produced by growing Corynebacterium diphtheriae in Fenton medium containing a bovine extract. Tetanus toxin is produced by growing Clostridium tetani in a modified Latham medium derived from bovine casein. The bovine materials used in these extracts are sourced from countries which the United States Department of Agriculture (USDA) has determined neither have nor are at risk of bovine spongiform encephalopathy (BSE). Both toxins are detoxified with formaldehyde, concentrated by ultrafiltration, and purified by precipitation, dialysis, and sterile filtration.

Distribution of adsorbed antigen in mono-valent and combination vaccines
Garry L. Morefielda, Harm HogenEschb, J. Paul Robinsonc and Stanley L. Hem, , a

a Department of Industrial and Physical Pharmacy, Purdue University, 575 Stadium Mall Drive, Room 124, West Lafayette, IN 47907 2051, USA b Department of Veterinary Pathobiology, Purdue University, West Lafayette, IN 47907, USA c Department of Basic Medical Sciences, Purdue University, West Lafayette, IN 47907, USA

Received 13 August 2003;  Revised 20 October 2003;  accepted 23 October 2003.  Available online 17 December 2003.


The distribution of alpha-casein, bovine serum albumin (BSA), myoglobin and recombinant protective antigen (rPA) in mono-valent and combination vaccines containing aluminum hydroxide adjuvant was studied by fluorescence microscopy and flow cytometry. Green and red fluorescent probes were conjugated to the antigens. Adsorption isotherms of the fluorescently labeled proteins to aluminum hydroxide adjuvant demonstrated that incorporation of the fluorescent probe did  not significantly affect the adsorption. In mono-valent vaccine systems, antigen adsorption occurred within one minute and uniform surface coverage of the adjuvant aggregates was observed within 1 h. Content uniformity was achieved through a cycle of de-aggregation and re-aggregation of the aluminum hydroxide adjuvant aggregates caused by mixing. For combination vaccines, two antigens
were adsorbed separately to the aluminum hydroxide adjuvant prior to combination. Following combination, cycles of de-aggregation and re-aggregation occurred due to mixing, which led to uniform distribution of both antigens. The results of this study indicate that content uniformity should not be an issue during the production of mono-valent or combination vaccines as long as adequate
mixing procedures are followed.

Author Keywords: Content uniformity in mono-valent and combination vaccines; Antigen adsorption by aluminum hydroxide adjuvant; Fluorescence microscopy; Flow cytometry

Corresponding author. Tel.: +1-765-494-1451; fax: +1-765-494-6545

Autism and Malnutrition: The Milk Connection


By Linda Carlton

To understand autism we can begin this journey from what we have learned about how seemingly insignificant dietary changes can affect newborn primates. In October 1975, three Japanese scientists raised a group of infant primates. By artificial nursing, these primates were fed a casein powdered milk formula. When they modified the infant formula to reduce the content of protein and increased the lactose to supplement the appropriate number of calories, the primate infants developed abnormal behaviors such as stereotype rocking, fear, aggression, head banging and other autistic-like behaviors. Completely unaware of what they had discovered, the scientists had induced autism in a clinical setting.

Now, they were aware that by reducing the protein content they caused the infants to become malnourished. They also observed that without human contact some infants were much more impaired. They learned that the infants that received the standard solution were reared successfully. At that time they concluded that a protein deficiency had caused a decline in physical and mental growth. Subsequent studies have supported this, whereby protein deficiency does cause developmental delay.

Autism Versus Developmental Delay

But it is important to know which symptoms are truly autistic and which are that of developmental delay. These disorders are often used interchangeably, but they are very different. For example, hand flapping is an autistic symptom, but it is not a common characteristic of developmental delay. In developmental delay children are often slow to learn, and will quickly fall behind their peers. The symptoms of these primates were more than just symptoms of developmental delay--they were symptoms of autism.

The most important information we have about these infant primates is that the researchers had also increased the lactose content in their diet. If the quantity of protein matched that of the quantity of lactose, this might not have occurred, or it might also have occurred if they had been fed too much protein. The standard formula given to the infant primates that were reared successfully were given the same amount of lactose, and what would have been the normal amount of protein for these size mammals.

Lactose and Autism

Lactose is the key to unraveling what happened to these infants. Bacteria use lactose, or milk sugar, as a nutrient base. Bifidobacteria and clostridia use lactose, and they often describe these strains of bacteria as lactose-fermenting bacteria. One difference in Bifidobacteria and Clostridia is that only one can produce significant amounts of ammonia, only one can damage the intestines. Milk oligosaccharides contain lactose; they are fermented in the infant colon where they selectively stimulate the growth of Bifidobacteria. Clostridia are competitors of Bifidobacteria, and Clostridia produce ammonia. Ammonia and only ammonia produced from bacteria could have caused the aberrant behaviors.

The infant primates had developed symptoms of autism because there was protein restriction, milk proteins needed for ammonia detoxification, and not necessarily just casein. They were fed lactose and lactose ferments ammonia, producing bacteria. They were unable to detoxify on a protein-deficient diet. It is a simple formula:

Protein + Lactose = Normal Development
Low protein + High Lactose = Autism

But protein malnutrition does not equal autism nor does lactose feeding equal autism. However,

Protein malnutrition + high-lactose feeding + (the unknown factor) = Autism

There has to be an unknown factor for this to occur, a combination of things that all relate to one another. The unknown factor can be found by testing these three variables. We have to review other information that we have on children with autism to give us the correct answer to the unknown factor.

A low-protein diet offsets a nitrogen balance to detoxify ammonia, whereas lactose feeding ferments bacteria. The only variable that could account for the unknown factor is ammonia. In autism, there are signs of ammonia detoxification, for example when GABA and nitric oxide are increased. So instead of developing overt ammonia toxicity, they are able to detoxify this excess ammonia. As encouraging as this sounds it still depletes cellular energy. Many parents can recall 'staring spells' as the first behavioral change in a child prior to autistic regression. This can be the first sign of increased blood ammonia.

Other symptoms found in children with only minimal increases in blood ammonia were:


Developmental regression


Loss of acquired speech


Stereotype hand movements


Myoclonic seizures


Generalized epileptic discharges


Repetitive behaviors


Sensory dysfunction


Auditory and visual hallucinations

Finegold and his colleagues have published three studies on children with autism. The first study was with the use of antibiotics. The second study of stool specimens indicated a vast overpopulation of Clostridia in children with autism. Many physicians use antibiotics for treatment of elevated blood ammonia to kill the ammonia-producing bacteria. Antibiotics have produced dramatic effects in children with autism, however this treatment did inevitably fail. Experiments with fermented foods after antibiotic treatments have been somewhat successful in preventing relapsing Clostridial infections.

Live Bacteria to Temper Immune Response

As many of us already know, treatment with probiotic supplements at most show only minor, if any, improvement in autistic symptoms. These can sometimes take weeks or even months to take affect or may never have any effect. The reason for this is that when probiotic bacteria are dried and then rehydrated, even with prebiotic assistance it takes time for these bacteria to reestablish a colony. When live bacteria are frozen they can re-colonize within 24 hours at room temperature, but when bacteria are heat-killed they induce an immune response and their ability to re-colonize is remote. Each time we consume foods with heat-killed bacteria it produces an immune response.

Every time we receive a vaccination with heat-killed bacteria or a heat-killed virus, it produces a similar immune response. Live bacteria such as that of lactic acid bacteria can temper these immune responses. The infant primates were fed heat-treated formulas, Clostridia is an opportunist infection, looking for a chance to colonize. However, Clostridia is also a natural inhabitant of the colon. The problem here with heat-treated foods is that you might as well say they are sterile. If you are feeding sterile foods, they don't contain bacteria that can form a colony. So in order to colonize bacteria you have to consume foods with live bacteria or an opportunist will take that invitation.

Breast-fed babies are colonized naturally by Bifidobacteria. Babies fed formula develop much more harmful fecal environments. Preterm infants are especially at risk for Clostridrial infections because there is usually a delay in breast feeding. In older children generally pathogenic Clostridial infections develop after antibiotic treatment, which can destroy the beneficial bacteria derived from the mother.

Impaired Digestion and Pasteurized Milk

Pasteurized milk causes the impaired digestion of casein and other proteins found in milk. Malnutrition is caused by either an insufficient diet or an impaired utilization of foods. Malabsorption is the impairment of intestinal absorption of nutrients. Some children with protein-calorie deficiency had abnormal intestinal fat absorption, and because of this they had an increased uptake of serotonin in the plasma. One scientific study found hyperserotoninaemia in 70 percent of their autistic patients. It should come as no surprise that serotonin uptake inhibitors have had some success in treating autistic children. The medical literature supports the realization that protein deficiency causes developmental delay and even mild increases in ammonia causes oddities in behavior.

Some methods of ammonia detoxification have been suggested with the use of lactulose, oral lactulose and the drug Tributyrate, which can scavenge excess ammonia. Lactulose can cause extreme irritability in children, and perhaps its use with autistic children was abandoned due to these circumstances.

Impacted Colons and Pasteurized Milk

Children with autism frequently have impacted colons. Clostridia is notorious for reducing the quantity of water in the colon. Hard dry stools can cause irritability once stool-softening products are started. These stools might only be removed by using an enema prior to beginning any stool-softening treatment. Once the bowels have been cleared of extremely hard, dry stools, then treatment with stool softeners can begin.

What we have to consider is the matter of colonizing bacteria. A healthy colon in a normal infant contains a significant supply of Bifidobacteira. Pasteurized milk simply putrefies in the colon and hinders the passage of fecal matter. Pasteurized milk contains heat-killed bacteria and is unable to reflourish the colon with host-friendly bacteria--unless contaminated, it is sterile.

When milk proteins are damaged by heat processing it renders them indigestible. Raw milk does not cause constipation. Constipation is caused by the loss of moisture. Lactose and lactulose add moisture back to the colon, but clostridia can quickly dry up the feces. Raw milk is easily digestible by infants, for as long as babies have been born mothers have been feeding their young casein and other milk proteins. Clostridia can feed on unabsorbed lactose from the diet. Lactose is completely hydrolyzed in cheeses made with bifidobacteria.

Autism and Casein-Free Diets

Science cannot support the presumption that a casein-free diet reduces autistic symptoms. All the literature on casein restriction indicates this only causes a developmental delay. If an improvement is seen on a casein-free diet, it is only because of the removal of free lactose, and the removal of constipating foods. The very worst thing that you can do to a child coping with mercury is to wean them off of breast or raw milk. Weaning causes the hair and blood mercury levels to suddenly drop, and it is re-routed to the colon for excretion. If the child is constipated, it could mean real problems.

Now we know three Japanese researchers were able to induce autism in a clinical setting, with a low-protein, high-lactose, sterilized formula. The belief that infant-mother separation or the refrigerator mother causes autistic symptoms continued for many years. Understanding what happened to these infant primates could have changed the course of medical history. Unfortunately, two new theories of what causes autistic symptoms have followed.

Treating Autistic Symptoms

To treat the symptoms of autism, we have to feed our children foods that they can digest, foods that do not cause constipation, foods that will give them back the bacterial environment to temper these inflammatory conditions. And most importantly return to proper nitrogen-ammonia balance.

Treatment should begin with a healthy diet, high in quality protein foods such as eggs, meat, milk and cheese and balanced essential oils. Raw goat's or raw cow's milk may be given. If not well tolerated, then cultured raw milk/kefir can be used. Oral, inexpensive butyrate may be given to both clean the colon and to detoxify ammonia from the liver and bowels.

To finalize, there are still the issues of treating malabsorption, the impairment of intestinal absorption of nutrients and abnormal intestinal fat absorption. To begin nutritional rehabilitation for your child you will need some help navigating through the complicated process. Dr. Patricia Kane has treated thousands of children with autism over the past 25 years who have not only had malnutrition, but also abnormal intestinal fat absorption. Restoration of digestive function is critical to absorbing dietary essential fatty acids and stabilizing the nutrient base.

Japanese scientists in 1975 documented the development of autistic symptoms and revealed how diet can induce these symptoms. In 2004 we now have the tools to eradicate the symptoms of autism.

From: "Robert Cohen" <>
Subject: NY Times Milk Reporting Cause Mucus

Read the New York Times for really bad health advice, and keep in mind this fact: Full page  milk mustache ads often have influence over editorial content. The latest NY Times milk  promo claims that milk consumption does not cause mucus. That story is dated Aug. 10, 2004:

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When designing phony scientific studies, the outcome can be easily manipulated based upon experimental bias. Got milk dollars? Many scientific researchers do.  Dairy industry-financed mucus studies test human subjects shortly after they consume milk, and then finding no  immediate effect, incorrectly conclude that milk consumption does not cause mucus.

Milk proteins, particularly casein, do indeed cause mucus, but the allergic reaction in which internally secreted histamines produce mucus can often take 12-15 hours. By that time, the human subjects have gone home from the study, and the real results are not observed.

Let's take a look at a tragic study of just one individual. Her name was Florence Griffith Joyner. People called her Flo Jo. This great athlete won Olympic medals in the 1984 and 1988 games. Ten years later, she would die from the mucus created after her last meal, pizza. No phony study predicted her fate, or the fate of thousands of others who are similarly affected each year. In Flo Jo's case, the mucus took 15 hours to congest the bronchioles of her lungs so acutely that breathing was no longer possible.

Flo Jo ate pizza at 3 PM. Fifteen hours later she would die. Undigested mozzarella cheeze the size of a brick would be found by the coroner in her stomach. Fifteen hours, and still undigested. Flo Jo's fingermarks were on her own throat. She could not breathe, and her last living act was to frantically
grab at her own throat, futily gasping for breath. The congestion had progressed from lungs to other organs. Her death was inevitable. Residues of two drugs were detected in Flo Jo's blood. One was aspirin and the other Benadryl. Benadryl is an antihistamine. Flo Jo had histamines produced in her body. She was congested. She took Benadryl to relive her congestion.

Here is what the autopsy reveals about Flo Jo's internal organs. The coroner wrote:


"The lobes of the lungs are light-pink-to-dark-purple with marked congestion and a large amount of frothy fluid exuding with pressure. The lumen of the tracheobronchial tree contains mucus and frothy fluid." Flo Jo's lungs were congested. She could not breathe.


"The small and large bowels show congestion...the liver has a congested appearance... pancreas, congested appearance... the pyramids of the kidneys are congested... section shows marked acute congestion...cut sections of the adrenal glands show acute congestion...a large amount of frothy fluid is present in the larynx...cut sections of the thyroid gland show congestion...congestion is noted in the pancreas." On and on, organ after organ, filled with a glue produced by the body's defense to this powerful allergen and tenacious glue. Flo Jo paid for her ignorance with her precious and beautiful life.

Milk and dairy products cause Crohn's disease, mucous and irritable bowel syndrome -- interview with Robert Cohen
The following is part one of an interview with Robert Cohen, author of "Milk, the Deadly Poison," and

Mike Adams: Would you be willing to provide an overview for people who aren't familiar with the real story of dairy products and cow's milk? What are the main things people need to know about milk that they don't already know?

Robert Cohen: The real story is that dairy products are the tastiest foods on this planet. There is nothing more delicious than cheese -- a day without cheese is a day without sunshine. Milk is yummy, especially if you take 12 pounds of it and get rid of all the water, mix it with sugar, freeze it and put a cherry on top. Milk, dairy, cheese, ice cream, yogurt -- I don't know how I ever lived without these things. I was probably the biggest dairy consumer in the state of New Jersey where I lived, and so were my kids. Until one day something called genetic engineering hit our table, and I started investigating whether I wanted my kids to drink good old wholesome milk, or the genetically engineered milk.

I used to run a lab -- I did research, and I tried to take a pretty fair look at all of the controversies regarding genetic engineering. This was back in '94, and I started reading scientific journal articles about GMO milk. I started investigating, calling Monsanto and speaking with their scientists. One day it hit me -- after doing a week, a month, a year of investigations, it hit me -- it's milk, stupid! Cow's milk, every sip of cow's milk has virus in it; and pus and bacteria, powerful growth hormones, proteins that cause allergies, antibiotics, pesticides, fat cholesterol and dioxin -- now, which one of these things do you want in your body?

Mike Adams: Now this is a big shock, I think, for most people to hear this kind of information.

Robert Cohen: Well, you know, it really isn't a shock, because most of your listeners, if I said to them, "Here's a nice ice-cold glass of pig milk to drink with your brownies," or "How about some dog milk with your chocolate chip cookies," they'd get sick. They'd say, "No way!" They'd know instinctively not to do it. As a matter of fact, you couldn't even tempt them with a chilled glass of human breast milk. They'd get sick at the thought of it; because they know that there are substances in those milks that were intended for the young of the species.

And those substances have names -- they are lactopherins, immunoglobins -- you don't want to eat estrogen everyday, and progesterone, and proactin and melatonin and oxytocin, and I can go on and on and name 59 different hormones in every sip of milk. That's what milk is -- it's a hormonal delivery system. And you don't want dog hormones or pig hormones. You don't want cow hormones. You don't even, as an adult, want human breast milk hormones.

Mike Adams: That's right -- it's perfect food for infants, but not for adults. I always found it interesting that adult human beings chose to consume a food, a liquid food, from another species.

Robert Cohen: It is kind of interesting, and in the name of good health, at least make them healthy animals. But the 9 million cows in America, for the most part, are not healthy. Half the herds in America have cows affected with bovine leukemia virus, half the herds have cows infected with a disease called Crohn's disease, which is caused by a bacterium called mycobacterium paratuberculosis, which 40 million Americans have been affected with irritable bowel syndrome from this. Every person with Crohn's disease tests positive for mycobacterium paratuberculosis. Every one! One hundred percent! And this was published in 1965 for the Proceedings for the National Academy of Science. So we're talking about real science, here, not things Iím making up. You've got thousands of studies published in scientific journals, thousands of converging lines of evidence that tell us that milk does not do the body any good. We drink body fluids from diseased animals.

Mike Adams: What about hidden sources of milk, because there are a lot of products that have milk or milk proteins -- I know a lot of protein bars, for example are made with milk proteins.

Robert Cohen: Well, sure. You've got to see the word "whey," you say "no way!" You see the word "casein," "sodium caseinate," "calcium caseinate" -- that's the milk powder protein that you don't want in your body. When you take milk and you get rid of the fat and you get rid of the water and you're just left with protein, and basically they're blood proteins, serumalbumin, milk protein, 90% of it is casein. Now, casein, when it's extracted from milk, it's actually a glue used to put a label on a bottle of beer. It's the glue used to hold together the wood in your furniture. When you eat this casein, this glue from milk, and your body is seeing this foreign protein, and you're producing these histamines which end up as mucus. And that's why it is mucus-forming. Again, it's a process that takes 10 to 12 hours.

Mike Adams: So what other types of foods or protein bars or any other kind of product will people find this casein?

Robert Cohen: Well, sometimes you'll find it in tuna fish, believe it or not. Sometimes you'll see it in certain cereals -- it's used as a glue to hold together certain foods. But what's remarkable is you'll look at things in the supermarket, non-dairy creamers, for example, and you see non-dairy creamer written on the front, then you turn it to the back and you look at the small print, and you'll see "sodium caseinate, a milk derivative." I do not know how they get away with calling something non-dairy when it's dairy. But you've got to learn to read the tiny print on labels. If you see the word "casein" in any way, shape, or form, caseinate, that's milk from cows -- don't eat it.

Mike Adams: Food manufacturers, as you know, are pretty creative with their labels. I've seen avocado dip, guacamole, with no avocados in it!

Robert Cohen: You're kidding me! That's amazing!

Mike Adams: Yeah! It's hydrogenated oils and artificial color.

Robert Cohen: That's scary.

Mike Adams: And that's the main stuff you get-- you have to go to a health food store or somewhere special...

Robert Cohen: Well, you see the problem here Mike is that we don't have a very strong guacamole lobby. But we do have a strong dairy lobby, I'll tell you that. Continue with part two.

Learn more about: Robert Cohen | cow's milk | dairy products


Milk and dairy products cause Crohn's disease, mucous and irritable bowel syndrome -- interview with Robert Cohen

Consequences of Hidden Milk in Groceries

Eighty percent of milk protein is casein. When casein is extracted from milk, it is used as a glue to hold together processed foods. When you eat casein, histamines are produced, then mucus.

Last night, I ate pizza at a vegetarian friend's house. I was assured that the cheese used was vegan. This morning, my body assures me that it was not. I am fully congested. Such coincidences do not happen. My body is so finely tuned, that it exists as a barometer to my own internal atmosphere.

I do not eat meat, but I learned long ago that if one orders baloney or salami or pepperoni from the deli counter, one is also ordering milk. You see, milk protein holds together the finished product. Casein binds ground sausage and hot dogs like a tenacious glue. Eat hidden casein in meat products and you will need to cleanse yourself many hours later. Usually, that is an overnight experience. As one sleeps, the histamines clog internal organs, blood, intestines, and lungs. Upon waking, one's first response is to spit up phlegm. The next few waking hours are spent expelling phlegm and mucus. Those companies marketing Kleenex and Charmin become the beneficiaries.

Ten to fifteen hours after ingesting casein, you are guaranteed to know the congesting effects. You'll spit up phlegm, and your morning (or next) bowel movement will be pure sludge. I do not have to get too descriptive. You've experienced this same effect too.  Be aware that "non-dairy" products may contain casein.  A list of label ingredients containing milk protein might surprise you. Some of the ingredients surprised me, and I thought that I knew almost everything there was to know about milk ingredients in food. Clearly, I did not.

The following information comes from:


"These ingredients may contain milk protein - ammonium, butter, rtificial butter, butter solids/fat, calcium, caramel color, caramel flavoring, casein, caseinate, ammonium caseinate,  calcium caseinate, hydrolyzed casein, iron caseinate, magnesium caseinate, potassium caseinate, rennet casein, sodium caseinate, sodium caseinate solids, zinc caseinate, cheese, cream, curds, flavoring, high protein flour, lactate, lactic acid, lactalbumin, lactalbumin phosphate, lactoferrin, lactaglobulin, lactose, magnesium, margarine, milk, buttermilk, milk derivative, milk fat, milk protein, milk solids, skim milk, powdered milk, dried milk, dry milk solids, sour milk solids, hydrolyzed milk protein, natural flavoring, Opta (fat replacer), Simplesse (fat replacer), sour cream solids, whey, delactosed whey, demineralized whey, whey protein concentrate, whey powder, and yogurt."

Those "natural flavorings" will get you every time. When contacting manufacturers, you will usually be told that the "natural flavorings" are "Proprietary." That means, secret. The same individual will not know whether or not they are "dairy." Often times, neither will the food scientists, since natural flavorings are manufactured for food processors by third parties. In other words, avoid those foods with natural flavorings. These chemicals do not do the body any good.

Take responsiblity for your actions. If you do the wrong thing the night before, expect to face the consequences the morning after.

Robert Cohen

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