Getting the right formulation to assure the stability and activity in the early phases of drug development integrated with process development can minimize the potential for costly reformulation in later phases.
Our highly skilled team is experienced in designing an appropriate development strategy, considering the commercial application and route of administration, using regulatory approved reagents and excipients, to target and control specific degradation pathways and protect Critical Quality Attributes.
The approach taken by Rodon is based on first establishing a comprehensive understanding of the thermal, physical, chemical, and conformational stability of the protein in early preformulation studies. This includes stress studies to promote degradation which allows for a clearer selection of reagents and excipients for further formulation development and identification of stability indicating methods. Design of Experiments (DOE) approaches are used for simultaneous testing of multiple factors and interactions between factors.
A full range of analytical methods, are available to support these activities with relatively low amounts of product. 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