Topical drug formulation and production is complex and presents unique developmental and manufacturing challenges. As a result, when life science companies develop new topical formulations, the lack of in-house capabilities in pharmaceutical research, drug development, testing, and manufacturing, can place stubborn obstacles in their drug development journey. It is here that Tergus Pharma, an end-to-end service provider for topical pharmaceutical development and manufacturing, steps in. The company acts as an extension of its client and supports them through the entire drug development lifecycle. With Tergus Pharma’s services, pharma companies do not need to worry about the nuances of commercial drug development and manufacturing processes. Starting with high-quality R&D services at the pre-clinical stage, Tergus extends its capabilities from early skin biology services through clinical trial materials manufacturing to deliver end-to-end development continuity. "We are a CDMO with unmatched capabilities in dermatological drug development and manufacturing," mentions Dr. Vijendra Nalamothu, Chairman and CEO of Tergus Pharma.

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 it, the company follows common Good Manufacturing Practices (cGMP) to ensure quality and rigorous documentation during every step of the manufacturing process, including material management and quality oversight. Such practices enable them to maintain the desired viscosity, permeability, rheological behavior, and all other related quality factors when they scale up the production. As any change in the process affects the dynamics of the product and subsequent clinical trials, their robust quality system helps keep the manufacturing process consistent.

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.