Manufacturing
Top9Proteins is the premiere source for high quality, clinical-grade, pure, and fully characterized food proteins to the professional health care community.
Focus on the Top 9 Foods
Top9Proteins works with a global network of suppliers and manufacturing partners to produce a consistent supply of cGMP and foods. Each food requires specialized machinery, know-how and manufacturing controls to ensure the foods have the expected allergenicity, and can remain shelf-stable for the duration of use. Top9Proteins sets stringent specifications for, or directly controls, all of its manufacturing and packaging.
Good Manufacturing Practices (GMPs)
Top9Proteins follows all requirements for the highest level of manufacturing certification. Each product and manufacturing process is designed to ensure:
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Foods start from superior raw materials grown or raised with care
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Foods are pure and free of cross-contamination
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Raw materials are certified free of heavy metals, pesticides, and microbiological organisms
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Protein potency, or allergenicity, is determined using validated analytic methods
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Products are manufactured at FDA registered facilities with stringent internal quality control procedures and documentation systems and the requirements of the FDA Dietary Supplement Good Manufacturing Practices (GMPs)
Validated Quality
Top9Proteins analytic methods were developed by the team behind multiple FDA approved products in the food allergy space. Our methods follow the FDA requirements analytic method development and validation including the use of consistent standards and the verification of methods against human IgE reactivity. Many of Top9Proteins methods were developed for and are used in current and ongoing FDA clinical trials. Top9Proteins also partners with leading institutions and researchers to demonstrate both in-vitro and in-vivo tolerance of our proteins. More information on these studies can be found in the Science section. When health care professionals purchase from Top9Proteins, they can be assured of our commitment to the research and science behind food proteins that will help advance patient care.
