Challenges Of Concentrating And Ultra-High Concentrating Protein Therapeutics To Improve The Patient Experience And Reduce Manufacturing Cost

By Anthony Stewart, Process Engineer, Kymanox Corporation

Developing high or ultra-high protein concentration formulations for biologics-based protein therapeutics can offer numerous advantages for both patients and pharmaceutical companies. These formulations allow for easier administration routes, such as subcutaneous injection, resulting in reduced costs, pain, and complications for patients, as well as time savings for physicians. Additionally, higher protein concentrations can lead to manufacturing cost savings and provide a competitive edge for companies.

However, achieving stable, high-quality drug products at high or ultra-high concentrations is not without its challenges. Physical instability and high viscosity of the drug product are common obstacles that need to be addressed. Thankfully, there are strategies available to overcome these challenges. Formulation optimization and the addition of viscosity modifiers can help improve stability and reduce viscosity. Furthermore, researchers are exploring lyophilization techniques and non-aqueous protein powder suspension formulations to achieve even higher protein concentrations.

While non-aqueous protein powder solutions have strong research support, there is currently no market precedence for these formulations. The complex manufacturing process and the need for extensive analytical development pose additional challenges. However, the potential benefits make this an exciting opportunity for companies. Achieving low viscosity and high protein stability can lead to cost savings in manufacturing and enhance the overall drug administration experience for patients and physicians.

Early consideration of high protein concentration formulations can maximize the benefits and overcome the challenges associated with developing these products. By addressing physical instability and viscosity issues, pharmaceutical companies can potentially improve patient outcomes, reduce costs, and gain a competitive edge in the market.