Developmental Activities:
- cGMP fill and finish operations for pre-filled syringes and auto-injector systems
- Chemistry and Manufacturing Control (CMC) sections of a Drug Application
- Identification and qualification of suppliers of device components and assemblies
- drug solution excipients and active pharmaceutical ingredients (API)
- Formulation development
- Container closure system manufacturers in the selection of drug contact materials
- ICH shelf-life studies
- Assay method and specifications for API, excipients and final drug product
- Identification of drug impurities
- Toxicology studies per FDA Guidelines