Capabilities
In addition to our manufacturing asset we also have the experience necessary to take a drug through the FDA process to final approval.
We have successfully accomplished this already as our IPLEX™ product was approved by the FDA in December 2005 for the treatment of growth failure in children with severe primary IGF-I deficiency (Primary IGFD) or with growth hormone (GH) gene deletion, who have developed neutralizing antibodies to GH. The combination of our manufacturing capacity, our unique protein manufacturing skill set together with our Clinical and Regulatory drug approval experience creates a significant competitive advantage and a potential "first to market" opportunity in the follow on biologics arena. Our unique collective experience in this area can be summarized as follows:
Clinical/Regulatory Experience
- Post Marketing Safety Surveillance
- Phase I - IV Clinical Studies
- Pre - Clinical Studies
Manufacturing Experience
- Commercial Production
- Process Validation
- Process Development, Optimization and Characterization
- Formulation Development
Analytical Experience
- Product Characterization
- Method Development and Validation
- Clinical Sample Analysis
