Protein Formulation and Process Development along with GMP Fill Finish Services from a Single Experienced Source

Formulation Development

(1) A lyophilized formulation for a therapeutic protein in early clinical trials was developed in two steps: preformulation characterization followed by formulation optimization. In addition to the client's analytical methods, a stability indicating assay was developed to support the formulation screening study. The final report and recommendation was delivered in less than five months. Features of the new formulation included improved stability and reduced injection site reaction.

(2) 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.

(3) The formulation of a product in a late stage clinical trial was optimized to improve its stability. In addition,a novel and robust formulation for commercialization was developed. The formulation was so successful that the client is seeking a formulation patent for the discovery of this technology.

(4) 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.

(5) 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.

(6) 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.

(7) Both formulation optimization and process development services were provided for a product which formed particulates during storage. The nature of particulates and the relevant stress were identified followed by minor formulation adjustment and recommendation of removal of the process related impurity.