As a leader in topical pharmaceutical development for more than two decades, Dr. Nalamothu understands the sector well. His company is fully equipped to cater to the regulatory requirements of the drug development process better than anyone. Consequently, when a client approaches Tergus Pharma with a new formulation, the company's R&D team begins the research process by testing the efficacy and safety of the formulation. They perform various tests to study the physical and chemical properties of the drug, such as solubility, permeability, and stability, to ensure efficacy. Leveraging various testing models to predict these characteristics, they can ensure the effectiveness of any dermatological product. As a result, Tergus Pharma’s R&D team understands the perfect level of chemical concentration that can bring better efficacy.
Furthermore, the company also uses a target product profile to outline the characteristics of the drug and ensure stability. Tergus Pharma can help ensure that the formulation doesn't cause skin irritation by using an in-vitro test model. They leverage cellular biological models to understand the irritation potential before the product goes for clinical trials, which reduces risk of adverse reactions during the trial.
After completing the R&D, Tergus Pharma moves on to the manufacturing stage to produce a small batch of products required for the early phases of the clinical trial.
Tergus Pharma: The One-Stop-Shop for Topical Drug Development and Manufacturing
We are a CDMO with unmatched capabilities in dermatological drug development and manufacturing
In one instance, a pharmaceutical company that had completed a Phase 2 clinical trial approached Tergus Pharma. The client needed help with their Phase 3 trial, but their product experienced mild separation due to changes in viscosity. After studying the client's existing process, the company discovered that it was unstable and did not match commercial regulatory requirements. Since changing the composition would make the earlier trials invalid, the Tergus team studied the CMA (Critical Material Attribute) and CPP (Critical Process Parameter) of the product thoroughly. After performing many DOEs (Design of Experiments), they were able to isolate the root cause. To fix it, they optimized a critical process parameter and identified the key Critical Quality Attributes (CQA) of the formulation to improve the process. The company also used the active release profile of the product from its early trials as a benchmark and was able to maintain the same release properties. After designing an ideal set of manufacturing conditions and improving the manufacturing process, Tergus Pharma successfully kept the viscosity index stable and helped the client successfully launch the product commercially.
Such success stories result from Tergus Pharma's commitment to helping its clients with their complex topical product requirements. Moving ahead, the company plans to utilize its recently opened commercial manufacturing facility and expand its business. This semi-solid manufacturing facility has a capacity of 30Kg to 1500Kg and enables them to package product in tubes, jars, pumps, and bottles. The facility is also equipped with isolated suites dedicated to manufacturing topical products containing highly potent active pharmaceutical ingredients (HPAPI) and sex hormones. The company has also acquired two large-scale manufacturing vessels with capacities of 5,000 Liters and 7,500 Liters, allowing Tergus Pharma to focus more on higher-volume over-the-counter (OTC) drugs in the days to come.