Formulation services
Streamline and optimize
drug formulation
Our automated High Throughput Self-Interaction Chromatography (HSC™) Platform is a self-contained, automated system that conducts high-throughput, self-interaction chromatography screens on FDA-approved excipients for protein formulations. With it, drug developers can decrease time and manpower required to optimize formulations.
Soluble Biotech is now Predictive Oncology.
Formulation development
We offer a tiered solubility screening platform and proprietary HSC technology to solve the inherent complexities of solubility and stability.
Stability assessment
Our full range of analytical techniques determine a drug's stability profile with respect to solubility, chemical modification, subvisible particles, thermal stability and photostability. These short-term assessments establish a baseline for future ICH stability studies.
Optimized formulation development
During formulation development, we start with a single excipient solubility screen to determine which of the FDA approved additives will improve the solubility and stability of your protein in solution—usually done in weeks, with increased agility, as compared to manual work in your own lab. The HSC Platform performs a comprehensive formulation screen that delivers the six most optimal formulations out of 4,000 possible combinations of buffers, excipients and concentrations—usually complete within 6 months.
What can formulation services do for you?
Identifying soluble and stable formulations for a candidate biologic drug molecule can take a long time. Our solutions compress the timeline to less than 6 months. It is all thanks to our proprietary HSC instrument that quickly and accurately measures protein-protein interactions.
After a formulation is identified, the FDA requires long-term stability testing and thorough endotoxin removal to progress candidate drugs to human clinical trials. We provide a full range of long-term stability tests to help pharmaceutical companies optimize this process.
Talk to us about formulation services today.
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