Selecting a Custom Formulator

In the nutraceutical industry, there are myriad options available for business partnerships. Whether youre looking for a custom formulator, a manufacturer, co-packer, or a full-service firm that can assist in every stage of development and production, assessing your companys needs will help narrow the field. Whether the goal is to formulate and bring to market a new product for the first time or to extend a brand by adding more products, there are important considerations to ensuring an auspicious launch.

A key to successful product formulation and production is clear communication. When developing a new product, be ready to communicate your marketing plan, target audience or population group, packaging needs and realistic projected volume. All custom formulators and manufacturers have limitations; therefore, knowing what the goals are at the beginning can save time during the process. An experienced formulator/manufacturer can offer suggestions to meet those requirements or suggest alternate vendors who may be a better fit.

Initially, establish a timeline for different phases of formulation development. Custom formulation generally begins with a customers idea for a particular product that meets the needs of a targeted market or population. The formulator will need time for research and development, including ingredient compatibility testing, sourcing, costing, and potency and stability testing. Stability is often not given enough consideration in formulation, but it is crucial because vitamins, minerals, natural coloring and flavors degrade over time. A product must maintain valid label claims throughout shelf life. Manufacturers can over-engineer ingredients known to degrade so the product will meet or exceed label claims at the end of the expiration date.

The preferred delivery modesoftgel, liquid, capsule, tabletaffects the timeline and final product efficacy. Ingredient issues impact product form, and vice versa. For example, is the formula designed to deliver B vitamins to a senior market? If so, a liquid form might be preferable to ensure compliance in a population that may have trouble swallowing; however, the B vitamins can add an off-taste, which would need to be addressed by formulators knowledgeable in flavoring liquids. It is important to find a partner with experience in producing a variety of product forms so they can identify the best fit for your product.

Early discussions should also explore the issue of ingredient sourcing, if the formulator will be producing the finished product. Inquire specifically about raw ingredient control measures, vendor qualifications, and paperwork including allergen reports, product spec sheets and certificates of analysis (C of As). Ideally, raw materials should be quarantined when they arrive until they can be tested and validated, either by an in-house or outside laboratory. Materials should then be tracked through each step of production. Testing specifications for the raw materials may involve assessing, sampling, testing, cross checking and inspecting for toxicity and factors such as storage, heavy metals, solvents, pesticide/chemical residues, microbiological analysis, potency of active ingredients, purity, appearance, texture, strength and consistency.

Fortunately, FDA recently released final GMPs (good manufacturing practices) for the dietary supplement industry, which should assist in assessing quality of manufacturing facilities. GMPs comprise a variety of practices that ensure quality including raw materials quality assurance, record-keeping of substances throughout the manufacturing process, standards for cleanliness and safety, qualifications of manufacturing personnel, in-house testing, production and process controls, and warehousing and distribution. GMPs provide continual measures of quality that can uncover problems and fluctuations as they occur and before the product is shipped.

The production timeline also should be discussed early in the formulation process. Considerations such as bottle or cap selection, label design and order volume can all impact launch dates. Volume capacity also comes into play, as there is a wide range of contract manufacturers and custom formulators in the marketplace. Consider touring the facility to assess the ability of the manufacturer to meet your expectations, including quality procedures and production standards.

Launching a new product is a partnership between businesses. Working with a custom formulator and/or manufacturer provides expertise, experience and knowledge in areas that your company may not be familiar. To leverage that knowledge, it is critical to explore the companys history of formulating products in different dosage forms and how they address challenges that may arise. Exploring the challenges that may occurfrom cost of goods to delivery systems to launch timelinesscan ensure the best possible partnership experience.

Fawn Wright is the national sales director for TRC Nutritional Laboratories Inc. (www.TRCCorp.com), a Tulsa, Okla.-based producer of vitamins and nutritional supplements. The TRC team has more than 27 years of experience in plant-derived mineral products, liquid formulations, encapsulation, tableting, mining and chemical formulation.