Production
EXCELLTM FERMENTATION AND BIOTECHNOLOGY CENTER
 
Cypress Opens East Coast Office

Cypress Systems, Inc. announced that in December, 2006 it opened an office on the East Coast (in Pensacola, Florida) with the main purpose of identifying potential partners and site selection for the company’s planned ExcellTM Biotechnology Center. The company has promoted Mark Whitacre, Ph.D. to COO & President of Operations. Dr. Whitacre is an executive with top management experience in leading Fortune 500 companies, and also has extensive experience in biotechnology and microbial fermentation. "His business and research experience fully aligns with the future direction of the company and the continued expansion into fermentation for biotechnology and life science applications", stated the Cypress CEO, Paul Willis.

In addition, Dr. Whitacre has significant experience with selenium research through his Ph.D. dissertation research at Cornell University on the biochemical role of selenium at the cellular level in the prevention of diseases. His research was under the direction of renowned selenium researcher, Dr. G. F. Combs, Jr. Furthermore, Dr. Combs was the co-investigator with Dr. Larry Clark of the Nutritional Cancer Prevention Trial, which studied the effects of selenium supplementation on the prevention of cancer. For more information related to Dr. Whitacre, please visit www.markwhitacre.com.

The company will explore several locations throughout the USA as possible sites for the ExcellTM Biotechnology Center. The company’s CEO & President, Paul A. Willis, states that "This is a significant step in the effort to expand the company's cancer prevention research base, develop next generation products, and seek new technologies to expand our existing product offerings. This Center and the key research personnel will greatly enhance our foundational involvement in the biotechnology and life science research and marketing arena"

Cypress Systems, Inc. is a biotechnology company with offices in Fresno, California. With the company’s flagship product SelenoExcell® High Selenium Yeast, Cypress has signed a Clinical Trial Agreement with the Cancer Prevention Division of the National Cancer Institute. SelenoExcell® is used as the sole intervention agent in a series of cancer prevention and health related trials.

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PRODUCTION TECHNOLOGY
 
Yeast Selection

The initial stage of the fermentation process begins with strong emphasis on yeast strain selection (Saccharomyces cerevisiae). We have selected our specific strain for its high protein content by dry weight, approximately 50-55% and its optional growth perimeters.

Benefits of primary grown yeast:

  • This strain is primary grown, giving us the benefit of working with an organism whose genetics and physiology are well understood and characterized.
     
  • An additional benefit related to primary grown yeast strains is that the only ionic challenge to these cultures is that of the specific mineral to be biologically incorporated. This cannot be claimed when using secondary bi-product yeast, such as traditional brewer's yeast.

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Fermentation

The primary culture is grown into a mother culture, or stock culture. Once the mother culture is grown, inoculation of the specific mineral to be incorporated occurs, and the culture is transferred into a commercial fermentor. While in the commercial fermentor, the culture is allowed to grow under aseptic, aerobic conditions during which time the desired mineral is being biologically incorporated into the yeast cell. Temperature, pH, and percentage growth are closely regulated while in the commercial fermentor.

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Washing and Pasteurization

Once the culture reaches optimum growth and mineral incorporation, it is removed from the fermentor, concentrated, and washed. The resulting product is known as yeast cream. The yeast cream is then pasteurized in a short dwell, high temperature sterilization system. This product is then dried to remove 94% of the volatile weight and packaged into fiber boxes, which are double bagged with 4-millimeter poly-bags. Boxes are sealed, labeled, and stored until all Quality Assurance and Quality Control tests have been completed.

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Drying

Cypress utilizes spray drying for the production of all its mineralized yeast products. Due to its consistency spray drying provides the most desirable product for tablet and capsule formulations. Dr. Lon Baugh applied this method of drying to mineralized yeast in 1980. It is the most commonly used method for the production of Inactive Dried Yeast. The initial sterilization of the yeast cream at 121° Celsius for 19 seconds, and the high temperature drying produce high quality, uniform, inactive yeast cells. The initial sterilization of the yeast cream occurs just prior to product entering the spray dryer's atomizer. This process assures that the finished product is inactive yeast, which meets all USDA microbial requirements for food grade products. Following sterilization the yeast cream is pumped to the top of the drying chamber, where it is forced through calibrated nozzles to form a fine mist, which dries in the warm air as it falls to the bottom of the drier. This procedure produces a uniform sized product where >97% passes through a 150 mesh screen and >95% passes through a 200 mesh screen.

Advantages of Spray Drying Yeast:

  • Commonly used to produce Inactive Dried Yeast
  • Lower capital investment and energy cost than the Fluid Bed Dryer
  • Produces consistent: particle size, moisture, colour, flavour, and solubility
  • Control of particle size to meet standard mesh requirements

The basic principle behind spray drying is feeding a liquid yeast cream into an atomizer, which is atop the spray dryer, where small droplets are formed. Upon entering the dryer, these tiny droplets are subjected to a stream of hot air and converted into powder as the product falls. As the powder leaves the dryer, it passes through a cyclone powder/air separator and is collected in a bag house for packaging.

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Certification

The fermentation process utilized in the production of Cypress Systems mineralized yeast is a well-defined process, which assures the highest quality product with minimal batch to batch variation. Strict adherence to this process enables Cypress the ability to certify its selenium and chromium products as 100% organically bound and free of measurable inorganic salts. After all tests meet or exceed Cypress' stringent requirements, the product is certified with a Certificate of Analysis and then released for sale.

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QUALITY CONTROL
 
By establishing a critical benchmark based on consistent high quality, we can assure customers and research groups that our product will enhance their product formulation. Therefore we have developed a comprehensive Quality Assurance / Quality Control (QA / QC) Program for the testing and reporting of Microbiology and Nutrient Analysis on all of our products.

Independent Third Party Testing

The first stage in our QA / QC program is to use leading, independent laboratories for all testing on Cypress products. This practice lends confidence to Cypress, and our customers, that our products meet or exceed USDA requirements for food grade material.

Silliker Laboratories perform all microbiology testing on Cypress products. For over 25 years Silliker has been a leading, independent food testing organization. They have grown from a single lab in 1967, to an international network of laboratories that specialize in assessing the safety, quality, and nutritional value of foods. Silliker Labs are USDA and FDA certified in Microbiology.

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Testing

All Cypress products are tested by Silliker Labs for the following: (included are USDA ranges for food grade materials and a typical Cypress product results).

Tested
USDA Food Range
Typical Cypress
Salmonella
Negative
Negative
E.Coli
Negative
Negative
Total Coliforms
< 10 / gram
< 1 / gram
Total Plate Count
< 7000 / gram
< 100 / gram
Yeast / Mold
< 50 / gram
< 10 / gram

In addition to the above tests, several times each year products are tested for Arsenic, Cadmium, Lead, and Mercury. Our results have been:

Arsenic
Non-Detectable
Cadmium
< 1 mcg / gram
Lead
< 1 mcg / gram
Mercury
< 1 mcg / gram

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Verification

Analysis to document nutrient content and organic binding is conducted by a FDA and USDA certified independent laboratory. Established testing methods have produced a 99% consistency in reported results.

Routine testing by an independent laboratory certifies that our products are absent of "free" and inorganic forms of supplemented minerals.

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Testing Methods

Sterile samples are obtained during the drying process to create a composite sample.

All analyzed samples used for Nutrient and Microbial Analysis are taken from the composite sample.

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Nutrient Analysis

The following test methods are used to obtain required data on nutrient specifications prior to the sale of product:

Test
Method
Selenium Content
ICP Method
Organic Binding - Free Selenium
Methylene Blue Test
Moisture
Gas Column Chromatography

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Microbial Analysis

The following test methods are used to obtain required data on microbial specifications prior to the sale of product:

Test
Method
Coliform
MPN
E. Coli
U.S. Pharmaceutical Method
Yeast & Mold
PDA
Total Plate Count
SMA Total Plate Count Agar
Salmonella
EIA, enriched with lactose broth in the first step of the method

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