Effectiveness of colostrum depends on its quality, and how it is sourced and processed

First of all, our colostrum comes from veterinarian certified healthy, bST, BSE and antibiotic free Grade A dairy cows from the Southwestern United States. We use only first milking, highest component tested colostrum. Our colostrum is certified to contain the highest possible naturally occurring levels of Immunoglobulins, Proline Rich Poly Peptides (PRPs), Lactoferrin, Growth Factors and other immune and growth factors. Our colostrum is pretested and post-tested (after processing) by HPLC to ensure that all of our colostrum’s components are intact and bioactive. No other manufacturer takes these extraordinary and expensive steps to insure that the colostrum you purchase is standardized to exacting pharmaceutical grade production standards. Only when we have the worlds finest colostrum possible do we then take the next extraordinary step of applying a Liposomal Enhanced Delivery (LD) system to ensure the colostrum will bypass digestion and be bioavailable for uptake and distribution to body organs and cellular nutrition.

Liposomal Delivery makes colostrum (and other nutrients) up to 1,500 % more bioavailable: Robert R. Milne MD

First Milking Colostrum: Quality First

Sovereign Labs collects only high quality first milking colostrum year-round from USDA Grade A dairies located in the Southwest United States.

Peptide levels in first milking colostrum vs later milkings up to the fourth day after birth

Sovereign Labs only accepts colostrum from the first milking produced before the calf is born. Colostrum from the first milking has significantly higher levels of Immunoglobulins (Ig), Proline-rich Polypeptides (PRPs) and other important factors.

In order to kick off the calf's immune system, it is vital the new born calf consume some of the first milking colostrum. Each cow produces about 18 liters of first milking colostrum at the time the calf is born. About half a gallon is fed to the calf within the first half hour after birth. About three hours later; the calf is given a boost of another half a gallon. Sovereign Labs then harvests the remaining 14 liters during a period of up to 16 hours after birth of the calf.

Year-round Collection

Sovereign Labs is located in the Southwest of the United States which has the largest concentration of dairy cows in the world. Calving occurs year-round in this area because of the temperate climate. This enables Sovereign Labs manufacturer to collect fresh colostrum all year. In much of the world (including New Zealand, Northern Europe, and Northern United States) most calving occurs in the spring because of the cycle of the seasons. As a result, colostrum products produced in these areas are manufactured only during the spring. Colostrum products from these regions are often not fresh — indeed, depending on the time of year, colostrum products from these manufacturers can be as much as a year old. And manufacturers in these regions often cannot respond to varying customer requirements during the year.

Manufacturing processes:

All of our colostrum products are manufactured in the most technologically-advanced colostrum production facility in the world, the only plant dedicated solely to the manufacture of colostrum for human consumption.

cGMP certified, FDA inspected, USDA licensed, Halal and Kosher certified

Highest Quality and Testing

All raw colostrum supplied to Sovereign Labs must meet 2003 Pasteurization Milk Ordinance (PMO) requirements. Sovereign Labs colostrum is only collected from USDA Grade A dairies. Raw colostrum from each dairy undergoes a testing protocol to assure it is from the first milking, free of antibiotics, pesticides and other testing parameters

All of Sovereign Laboratories manufacturing is performed under cGMP (certified Good Manufacturing Practices) and HACCP (Hazard Analysis and Critical Control Procedures) throughout the production process

Certified Quality Assurance

Colostrum quality

The immunoglobulin type G (IgG) content of colostrum is the traditional measure of its quality and effectiveness. Sovereign Lab's manufacturer tests and certifies the IgG content of its colostrum powders using in-house High Performance Liquid Chromatography (HPLC) and also uses one of its three in-house HPLC systems coupled with a Mass Spectrometer to quantify the levels of the important Proline-rich Polypeptides (PRPs) in each batch.

Analytical Chemistry and Microbiology

All products are sampled and tested using approved AOAC testing methods. Protein, fat, lactose, ash, and moisture are recorded for all products. Tests for other components are performed as required with an in-house Quadrupole Mass Spectrometer.

Aerobic Plate Count (APC or SPC), Coliform bacteria, E. coli, Salmonella spp., Listeria spp., Staphylococcus aureus, Shigella spp., Bacillus cereus, Enterobacteriaceae spp. and yeast and mold testing is performed along with other microbiological tests as required.

Environmental testing is preformed on drains and waste water sample points. Manufacturer also minimizes waste water by testing biological oxygen demand and chemical oxygen demand.

Clinical Laboratory

The on-site laboratory is registered with the United States federal government as a clinical laboratory. All products are sampled and tested using AOAC or other approved testing methods.

Chemistry Lab Instrumentation
Three Waters High Performance Liquid Chromatography (HPLC) Instruments with:
Quadrupole Mass Spectrometer
2 Variable UV PDAs
Refractive Index Detector
UV Spectrometer
Vacuum Moisture Ovens
Moisture Oven
Titration Units
Sediment Tester
Mojonnier Ether Extraction System for fat analysis
Kjehldahl Unit

Microbiology Lab Instrumentation
Polymerase Chain Reaction (PCR) Machine
Autoclave
Beta-Lactams Antibiotic Testing
Microscope
Colony Counter
Inhibitory Substances Tester

R&D Lab Equipment
Ion Exchange Systems
Semi-Scale Lab Separator
Lab Centrifuge

Laboratory Staff
Quality systems are under the direction of a PhD in biochemistry and considerable dairy processing experience. All four lab technicians have Bachelor's degrees in Chemistry or Microbiology, and there is also have a licensed Pharmacist on staff.

Documentation and Process Control
There are over three hundred Standard Operating Procedures that control all aspects of the production process. Every step of manufacturing, material handling, finished goods release, line clearance, employee training and certified Good Manufacturing Practices (cGMP) are documented. Thirty-two cameras show every movement in the factory. Remote access allows senior managers to consistently follow all manufacturing process variables.

Indirect steam colostrum dryer

Low-Heat Pasteurization
The high-heat pasteurization and drying processes used by many producers of colostrum powders can denature the sensitive PRPs and IgG proteins in colostrum. Sovereign Labs uses only low-heat flash pasteurization and low-heat indirect drying to preserve the efficacy and bioactivity of the colostrum. Manufacturing processing plant has a special High Temperature-Short Time (HTST) pasteurizer which meets all USDA Pasteurization Milk Ordinance (PMO) requirements. Using flash pasteurization (161º F or 72º C for 15 seconds) all potentially harmful pathogens are removed, while Immunoglobulins and other biologically important proteins retain their bioactivity.

Low-Pressure Processing
Similar to high-heat processing, high-pressure processing of colostrum will denature proteins and reduce the bioactivity of the finished product. All powders are consistently processed at lower pressures (often less than 10% of those used by other manufacturers).

Indirect Steam Drying
All colostrum is spray dried using indirect steam and with low pressure and temperatures (less than 145°F or 63º C) to produce a high quality powder while protecting the colostral proteins. Toxic NOx components produced in direct fired dryers used by other manufacturers are not produced in the indirect steam dryer. The US Food and Drug Administration limits the content of NOx components to < 10 ppm for infants. Sovereign Labs colostrum meets these strict requirements.

Quality Assurance
Certified Good Manufacturing Practices (cGMP) are rigorously followed in Sovereign Labs contract manufacturing process. There are over 300 Standard Operating Procedures (SOPs) that control all aspects of the production process. Every step of manufacturing, material handling, finished goods release, line clearance, employee training and certified Good Manufacturing Practices (cGMP) are documented. Thirty-two cameras show every movement in the factory. Remote access allows senior managers to consistently monitor all manufacturing process variables. The facility is inspected annually by the United States Food and Drug Administration (FDA) and by Kosher and Halal inspectors.

Testing

Each product batch is analyzed prior to shipment to assure its quality, efficacy, and safety. In order to ensure consistent high quality in every batch, analysis is also conducted during each step of the production process using equipment such as in-house High-Performance Liquid Chromatography units.

Dedicated Flexible Facility

Sovereign Lab's manufacturer uses its dedicated colostrum production facility exclusively to produce its high-grade colostrum products. Since no other products are made in this facility, the risk of cross-contamination from non-colostrum products during the manufacturing process is eliminated. In-house Liposomal Delivery coating, granulation and agglomeration ensures consistent particle size and allows the colostrum to more readily dissolve in liquids, which makes it more appropriate for encapsulations, and for mixing into infant milk formulas, milk products, beverages, ice cream, or cosmetics.