Drug Product Process Development Services
At the early phases of a program, very little is known about the process parameters and how components may interact with the drug product solution. Rely on our flexible, scale-adjusted study models and pre-sterile GMP-aligned components for rapid process development while minimizing risks.
Spanning from clinical through commercialization, our team has extensive expertise in drug product process development to ensure consistent GMP manufacturing performance and reliable product supply.
COMPREHENSIVE DRUG PRODUCT PROCESS DEVELOPMENT SUPPORT
- In-use stability studies
- In-use stability and dose accuracy study for syringe
- IV admixture studies for IV infusion drugs
- Material compatibility studies
- Drug product process material compatibility studies
- Drug substance/product container compatibility studies
- Extractable/Leachable assessment
- Drug product process development
- At scale freeze/thaw study
- Time out of refrigeration (TOR) study
- Mixing study at scale or with scale down model
- Pumping study (peristaltic or time pressure pump)
- Vmax and filtration study with scale down model
- Drug product process characterization
- Formulation robustness
- Process Performance Qualification
- Drug product manufacturing support
- Particulate and foreign material identification
- Process scale-up
Catalent Biologics’ drug product development centers in Bloomington, Indiana, USA and Limoges, France provide integrated solutions for development and manufacturing reducing risks and accelerating programs towards and through the clinic, and ultimately to market, as well as stand-alone development services.