Custom Approaches to Gene Therapy Development
- Secondary structure assessment and sizing
- Oligomeric state of nucleic acid particles in solution
- Purity analysis and quantitative detection of primary components
- Degradation products in raw materials
- Process samples and final drug substances
Comprehensive Molecular Support
We provide full-service, extensive analysis capabilities for gene therapies, including analytical methods, physicochemical, biophysical, and/or biopharmaceutical characterization. Our team’s comprehensive experience coupled with our advanced GMP facilities provides the analytical support you need to progress your novel gene therapy through manufacturing and commercialization.
Gene Therapy Development Resources
Pathway To Commercialization
Integrated CMC Development
Obtaining Orphan Drug Designations in the US and the EU for Rare Disease Treatments
Orphan designation programs at the FDA and the EMA offer incentives for sponsors to stimulate drug development for rare diseases, which otherwise would not be profitable due to small patient populations. This presentation will focus on what the orphan designation and RPD programs are, the incentives for obtaining such designations, and the required data needed to position your drug for regulatory success.
Integrated Laboratory Services
When your team needs additional CDMO support, our scientists are ready. Our state-of-the-art facilities and highly trained experts add power to your project.