One of the great benefits of using an experienced contract manufacturer is the ability to utilize its research and development (R&D) services. The services offered can range from simple formulations, complex formulations and pilot runs. An experienced R&D team is critical for the success of any contract manufacturerit is the key to manufacturing a well-made product that is stable, in accordance with specifications and efficacious. 

A successful product doesnt happen by accident; its a careful orchestration between the marketing, R&D, quality and manufacturing departments.  A smart marketing company will utilize the manufacturers R&D team at the beginning of the product development process. In other cases, the manufacturer is brought in at the end of the product development stage and simply given the purchase order to manufacture the product. While good manufacturers can figure out the formula and still make a good product, challenges can arise with difficult formulations or new ingredients during the manufacturing process. Therefore, when utilized properly at the beginning of the R&D phase, the contract manufacturers R&D team can ultimately help decrease lead time of the product, improve product quality and efficacy, and ensure batch-to-batch consistency.

The most commonly requested contracted service is simple formulationsthe customer communicates which active ingredients they want used, and the R&D team formulates the required excipients and amounts needed to finish the formula to make a finished dosage form. 

Complex formulations include the use of difficult raw materials. These are materials with properties that make the finished product much harder to manufacture, such as sensitivity to moisture (hydroscopic), fibrous, super-fine particle sizes, sensitivity to oxidation, temperature sensitivity, interactions, etc.  

Pilot services are important, especially for making complex formulation products. Pilot runs are a tried and proven way to check the quality of how any new formulation performs in production and as a finished product.  Pilot runs are often used to check the stability and compatibility of the final formulation.

Often, the R&D team is asked for suggestions to improve and expand formula claims and/or to decrease the cost. A good and experienced contract manufacturer R&D team can become a valuable extension of a clients technical team, leading to more efficacious products, shorter lead times and improved product quality.

Robin C. Koon is the senior vice president of Best Formulations.