Formulation Development

Every formulation project presents its own unique challenges. Here are some real world examples of our nimble and creative approach to issues that arise in the formulation process.

1

The purity of a drug substance was improved by optimizing the manufacturing process. First, a comprehensive characterization study was carried out which identified a major degradation product. A critical stability indicating assay was also developed. In-process samples were analyzed in the second phase of research and an improved process condition was recommended and subsequently implemented by the client.

2

A multi-dose formulation was developed for a product that may not be commercially feasible due to its inherently expensive drug substance. The developed multi-dose dose is not only stable but it also meets antimicrobial preservative effectiveness criteria. In order to develop a convenient device that can deliver the multi-dose formulation, we provided consultation and recommendations for the selection of the best device and subsequent business arrangements with the device manufacturer.

3

Room temperature stable lyophilized formulations were developed to support military applications. After general stability profile was examined with a preformulation study, lyophilized formulations with acceptable stability and efficient drying cycle were developed.

4

High concentration antibody formulations were developed to convert IV infusion product to subcutaneous injectable product packaged with prefilled syringe. After understanding the stability profile of the products, a novel formulation technology using approved excipients was applied to achieve high concentration by reducing aggregation, precipitation, and viscosity issues.