Formulation development aims to design a stable environment for the biopharmaceutical product, assuring the quality, safety and efficacy. Getting the right formulation in the early phases of drug development program integrated with process development can improve protein characteristics knowledge and minimizing the potential for costly reformulation in latter phases.
Our highly skilled team is experienced in designing an appropriate development strategy, always keeping in mind the commercial application and route of application, using regulatory approved excipients, which target specific degradation pathways and protect CQAs.
The approach taken by Rodon Biologics is based on first establishing a comprehensive understanding of the thermal, physical, chemical, and conformational stability of the protein on a preformulation study. This includes an accelerated stability study to promote protein degradation which allows for a more clear selection of compounds and excipients for further formulation development study. The experiments are design with statistical design of experiments (DOE) approach, allowing for simultaneous testing of multiple factors and interactions between factors.
A full range of analytical methods, low protein consumption, are available. Plus, our extensive characterisation and development experience enables us to provide targeted and rapid drug product development.
We Offer More
Looking for additional services? We offer even more services than listed, contact us to find out how we can assist you. Using latest advances in Protein Technologies Rodon Biologics strives to provide the highest quality custom protein services in the industry. We work closely with you, analyze your project at the planning stage and take several approaches to ensure you get the results you are looking for.Know More