Formulation Development
OVERVIEW
Technology & Methods
The formulation scientists at Catalent have experience in a variety of formulations and product presentations. The development team will integrate the biophysical and biochemical characterization of your molecule with the final product format, developing a formulation that will ensure delivery of a stable product to the patient. For products that need the added stability of lyophilization, the required lyophilization cycles can be optimized through the use of a LyoStar II™ development lyophilizer. Whether your molecule requires a liquid or lyophilized formulation in a vial or syringe presentation, Catalent has the experience and capabilities needed to develop and deliver your clinical or commercial formulation.
TECHNOLOGY & METHODS
- Molecular Developability
- Forced degradation
- Molecular Operating Environment
- Conformational Stability
- UNcle, Wyatt DynaPro III, NanoDSC, ΔG
- Colloidal Stability
- Dynamic and Static light scattering
- Solubility assays
- UV/Vis Spectrophotometry
- SoloVPE and Lunatic
- UHPLC Waters Acuity H class and Premier
- PDA, FLR, CAD, and QDa detectors
- CE-SDS with Caliper and Maurice
- cIEF with Maurice and CZE with Caliper
- Potency Assay with ELISA, BLI and ITC
- Solution characterization
- Low and high-throughput pH meter
- Viscosity with VROC Initium Plus and LOVIS 2000
- Density with DMA35 and DMA4500
- Tg and Tg’ with modulated DSC
- Tc with freeze drying microscope
- Subvisible particle analyses
- MFI, FlowCAM, AURA, and HIAC
- Biophysical Characterization
- EAF4, AUC, DSC, KF, CD
- DP Process
- Peristaltic and time pressure filler
- Material Compatibility, Freeze/Thaw, Mixing, light sensitivity studies.
- LyoStar III lyophilizer
- Automated Processing
- TECAN, Big Tuna, EpMotion.
LyoStar II is a registered trademark of SP Industries Inc.