Collaborations to Innovate API Development
Push the boundaries of what’s possible in drug development with support from our experienced team. Our team provides research and development capabilities tailored to your specific molecule and therapeutic applications. We leverage a network of nationwide laboratories to better understand the unique chemical, pharmaceutical, and business attributes your compounds have to offer.
Establish Foundational Insights
Conduct complete analytical characterization to identify the qualities and behaviors that will shape your drug substance and drug product development. Our team characterizes your biologics’ purity and identity, posttranslational modifications, protein aggregation, and other parenteral quality attributes.
Progress your drug substance through preclinical research by optimizing the product formulation and developing materials for further testing. Whether you face challenges with the dosing vehicle or simply need preclinical dosing supplies, our team is here to help.
Gain targeted insights with custom bioanalysis performed by our team to support lead selection and optimization. We offer comprehensive quantitative bioanalytical services across different drug development stages in parallel with our other analytical, formulation development, and manufacturing capabilities.
Custom Research & Development
The molecules listed below are widely used delivery methods for therapeutics. They function as carriers, safeguarding your API from environmental influences while also optimizing their delivery to the specific cell and tissue types where their action is needed. We partner with you to develop and execute research and development to drive your project forward.
- Virus Like Particles (VLPs)
- Viral Vectors
- Adeno-Associated Virus (AAV)
- Lipid Nanoparticles (LNPs)
- Antibody-Drug Conjugates (ADCs)
- Nucleic Acids
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.