Committed to Nutrition Science

We are committed to bringing to life nutrition products that enhance the health of those who use them. To us, that means innovation and quality. Research in the field of nutrition is exploding as we learn more about the interaction between nutrition and health. Our Ph.D.-led product development team and “Formulate for Success®” program give you access to the best, most innovative research and development in the industry, with attention to quality details every step of the way.

Science You Can Trust

By choosing Capstone, you will be working personally with our team of leading innovators, including Dr. Mark Pedersen, renowned nutrition and formulation expert, and our staff of Product Development professionals. Our wide ingredient, sourcing and formulation proficiency will become your inside team as we assist you with product formulation, flavoring and enhancement. From initial product concept and development, to advancements for your current product offerings, our team may introduce you to concepts you haven’t yet considered.

Successful product design takes into account many factors, including active ingredients, dosage form, regulatory requirements, as well as other excipient, shelf life and packing requirements. Our team evaluates each project for these and other considerations, possible solutions, and risks.

Dr. Mark Pedersen, ND, PhD 
- Director of Product Innovation

Dr. Mark Pedersen is a Naturopathic Doctor who is world-renowned in the formulation of nutritional supplements. He is an expert herbalist who understands firsthand the energizing and healing benefits of botanicals and minerals. Having dealt with numerous surgeries, health complications and traumas, and consistent hospital stays as a result of a nearly life-long battle with an incurable disease, Mark has written several books that discuss the medicinal use of fruit and herbal nectars. He is the author of nine global patents in the field of high performance mineral nutrition. Mark is also a medical advisor to several dietary supplement companies and an expert in herbal medicine and mineral nutrition.

Procurement, Sourcing &
Global Partnerships

Our team of scientists in Product Development and our world-class Quality Laboratory work in tandem with Procurement experts and Production Teams. Capstone promises industry-leading quality and accuracy, starting with premium raw materials and culminating in the unrivaled performance of our finished products.

Our sourcing and compliance are global in scale. We source thousands of nutritional ingredients from around the world, and produce products that are shipped and sold in more than 60 countries.

Experience What Sets Us Apart

Our formulation experts are on the leading edge of flavor, ingredient and nutrition science. Our state-of-the art R&D and testing labs will exceed your specifications and requirements. With decades of Product Development expertise, everything you need to create the perfect product can be found in our facility.

Our formulation experts are on the leading edge of flavor, ingredient and nutrition science. Our state-of-the art R&D and testing labs will exceed your specifications and requirements. With decades of Production Development expertise, everything you need to create the perfect product can be found in our facility.

Our Development team works with clients who need accuracy and precision in delivering specific active ingredients in their capsules, tablets and powder products. Our team, comprised of some of the brightest formulation and flavoring experts, is solution-oriented and able to work with different types, sizes, and delivery methods for each dosage form, while maintaining the integrity of active ingredients. We know your consumers will stay faithful to your brand if your product has the desired effect on a consistent basis, and it is Capstone’s charge to deliver your products with the consistency, uniformity and efficacy.

Working in parallel with the Quality department, new product development samples are tested for quality and potency throughout the process to ensure overall integrity and accuracy. Once satisfied with the final product specifications, Capstone’s Product Development team has proven its ability to transfer product formulations to production teams without the loss of quality or consistency. When transferred, our Production department is proficient at managing large quantities of blended materials, and manufactured capsules and tablets to ensure your brand is meeting end consumer demand.

 

Formulate for Success®

Innovation is at the heart of Capstone’s scientific operation. The critical balance is being able to deliver on the benefits and production of those concepts and innovations. Partnering with us gives you the formula for success, and helps your brand lead the way to more effective product launches and sustained market success. Formulate for Success® means you have the resources of Capstone Nutrition committed to the following:

  • Innovative and Exclusive Designs
  • Scientific Approach to Formulation
  • Formulate with Specification in Mind
  • Reduce Product Variation
  • Unprecedented Uniformity
  • Target Zero Failures
  • Identify Product Variation
  • CGMP Compliance for 100% Label Claims
  • Improving the Customer Experience
  • Improved On-Time Delivery
  • Drive Out Costs and Increase Profitability

Scalability

Years of experience means you can have confidence in the development, bench testing, pilot work, and scaling process. Successful scaling of any project takes methodical care and instruction, including blending times, equipment calibration, product testing and monitoring. Capstone’s passionate team of development specialists approach this process with serious commitment. A commitment to scientific approaches and doing things right the first time, ensure project success and outcomes that delight our customers.

Keeping You & Your Customers Safe

We operate under stringent quality control standards. From our disciplined sourcing and specifications of inbound raw materials and refrigerated raw materials storage capabilities, to our in-house analytical labs that verify identity and purity, and check for contaminants, to our industry-leading testing and process control, our operations lead the industry in product quality and safety.

Certifications & Registrations

We have a full complement of hard-earned Certifications and Registrations for worldwide nutrition and dietary supplement markets. We are fully certified for Australia’s Therapeutic Goods Administration (TGA), FDA and Health Canada registered, certified for NSF and NSF Sport, and cGMP compliant. We are renowned for Halal and Kosher certified products, as well as qualified to produce certified organic, non-GMO and other clean product types.

Food Allergens

-International Regulatory Chart

Wading through a world of regulations and legislation can be rough. Please use our interactive map to help navigate what food allergen labeling each country requires. International allergen regulations made easy! You’re welcome.

Check our Interactive Map!

Full Service Lab

Capstone Nutrition has a full-service laboratory providing a wide range of chemical and microbiological testing. We employ 20 full-time staff over two shifts, including 11 chemists, 2 technicians, and 4 microbiologists. Our experienced staff has decades of experience testing a wide range of dietary supplements including vitamins, minerals, and botanicals.

 

Testing

Capstone’s Quality Lab tests using accurate and reliable scientifically valid methods that deliver consistent results. We are committed to offering complete support service for our customers, to ensure their finished dietary supplements contain the correct ingredients, and the intended purity, strength, and composition.

The increasing capabilities of the Quality Lab provides Capstone with turnaround times of a week or less for internally tested and verified raw materials through production to tested and verified finished goods. Great relationships with external laboratories with equal accreditations reduces turnaround times at less than two weeks with complete accuracy.

Lab Capabilities & Instrumentation

Compendial Methods (UPS, BP, Ph, Eur,, etc...) - Following the leading directory of compendial testing in the United States Pharmacopeia National Formulary (USP-NF), the quality laboratory performs all the testing to validate identification, quantification, and purity of raw materials consistent with FDA standards to ensure our products are unadulterated and on-brand.

Disintegration - Capstone tests all of our outgoing capsules for disintegration capabilities, as well as tablets, if requested. Capstone’s Quality Lab can adjust for multiple methods of disintegration testing, and we work with our customers to set appropriate specifications for Capsule disintegration timing.

ELISA - Capstone employs the technique of validated Enzyme-Linked Immunosorbent Assay testing which lends the ability to accurately test for gluten in our products through the binding and detection of gluten proteins. Capstone can manufacture and verify that products are gluten-free with complete accuracy.

FTIR Spectrometry - Fourier-Transform Infrared Spectroscopy (FTIR) measures the wavelength absorption of infrared light over a wide variety of raw materials, liquid or solid, to determine raw material identity with complete certainty. Capstone Nutrition has amassed a library of thousands of raw materials, ensuring that all products entering the building are tested and confirmed for chemical identity through FTIR.

GC-MS - Gas chromatography–mass spectrometry (GC-MS) is an analytical method that combines the features of gas-chromatography and mass spectrometry to identify different substances within a test sample. GC-MS can identify trace elements in materials that were previously thought to have disintegrated beyond identification. Like liquid chromatography–mass spectrometry, it allows analysis and detection even of tiny amounts of a substance. GC-MS has been regarded as a "gold standard" for substance identification because it is used to perform a 100% specific test, which positively identifies the presence of a particular substance.

HPLC - High Performance Liquid Chromatography (HPLC) allows the quality department to provide accurate data for concentrations of active ingredients in raw materials and finished goods. Employing a mobile phase and stationary phase, this technology allows for determination of active ingredient identity through retention time analysis and for active ingredient potency through peak area determinations compared to validated primary standards.

HPTLC - Capstone partners with industry leaders in botanical testing and verification, with high throughput HPTLC (High Performance Thin-Layer Chromatography) to ensure complete accuracy when it comes to botanical identity and quality, as well as detecting adulterants, contamination, and incorrect plant parts. With an average turnaround time of under 5 days, all incoming raw materials used in our products are tested accurately and efficiently before they become finished finished products.

ICP-MS - Capstone’s in-house Inductively Coupled Plasma Mass Spectrometer instrument gives us the ability of early detection of heavy metals with unmatched speed, sensitivity, and precision to test for all heavy metals at once, compared to older atomic absorption technology.

Irradiation Detection (PPSL & TL) - Capstone Nutrition uses Pulsed-Photostimulated Luminescence testing to determine if incoming raw materials have been irradiated. With specifications in line with federal regulations, Capstone ensures that incoming products will have confirmation if those products have been irradiated. Capstone also partners with companies that perform Thermoluminescence testing to determine irradiation through molecular excitement during a heating process, to further determine if irradiation processes were used on incoming product.

LIMS - The newly acquired Laboratory Information Management System (LIMS) is a software system that allows the Quality Department to integrate instruments, automate workflows, and manage samples and associated information. This system enforces complete trust and accuracy in quality testing services and provides Capstone a level of unparalleled honesty in our communication of quality standards internally and externally.

Mercury Analysis - Mercury is a naturally occurring element, existing in the environment in several forms, including elemental, inorganic and organic species. Total mercury analysis is the most routine mercury testing procedure performed. Utilizing Cold Vapor Atomic Absorption (CVAA) technology, total mercury analysis is suitable for a variety of matrices in raw materials.

Microbiology Testing – Capstone’s Microbiology lab tests incoming raw materials and outgoing finished products to determine microbiological contents of products. Methods used follow USP, FDA-BAM, AOAC, and CMMEF guidance. Quantitative or Enumeration testing includes Total Plate Count, Yeast and Mold Count, Coliform Count, E. coli Count, Bile-tolerant Gram-negative Count, and S. aureus count. Qualitative or Presence/Absence testing can include E. coli, S. aureus, Salmonella, Bile-tolerant Gram-negative, Pseudomonas, and Clostridium testing. Routine microbiology testing has a five day turnaround time.

Moisture Analysis - Capstone uses both benchtop and partners with labs that have Karl-Fischer moisture analysis capabilities to determine moisture and water content within raw materials and finished products. With multiple heating options and measurement methods for moisture content, Capstone can determine water content completely and accurately.

Probiotic Testing – Capstone’s Microbiology lab has the capability of enumerating a variety of different types of probiotic bacteria using compendial methods and vendor specific methods. Probiotic testing includes lactic acid bacteria, Bacillus species, and probiotic yeasts. Probiotic samples may also be isolated and sent to an outsource lab for Genotypic identification.

Protein Analysis - Capstone’s protein analysis employs the Dumas combustion method to measure released nitrogen in the presence of oxygen from a combusted sample, which provides Capstone the capability to determine with complete certainty the potency of protein within any given product. With automated sample analysis and complete instrument control, Capstone has industry leading accuracy and turnaround time in protein determination, at just a few minutes per sample.

Titrations - Titration is a common laboratory method of quantitative chemical analysis to determine the concentration of an identified analyte. A reagent, called the titrant or titrator, is prepared as a standard solution of known concentration and volume. The titrant is added slowly to a known volume of another solution of unknown concentration until the reaction reaches neutralization, which is often indicated by a color change.

UPLC-MS - The newly integrated Ultra Performance Liquid Chromatography tandem Mass Spectrometer (UPLC-MS) provides the Quality Lab with industry leading technology capable of reducing assay testing in half, if not more. The combination of a Mass Spectrometer to the Liquid Chromatograph gives the lab data accuracy on the cutting edge of industry capabilities.

UV-Vis Spectrometry - Capstone’s Ultraviolet-Visible Spectrometer gives the quality lab the ability to verify and quantify analyte concentration of raw materials through wavelength absorption technology.