Formulation Development
Our comprehensive formulation development capabilities ranging from pre-clinical through commercialization, combined with our product-centric approach ensure faster delivery of a stable product. The development team will integrate the biophysical and biochemical characterization of your molecule with the final product format, developing the best formulation of your product for your patient.
MODALITIES & DOSAGE FORMS
| WIDE RANGE OF MOLECULES | MULTIPLE PRODUCT PRESENTATIONS |
|---|---|
Monoclonal, bi/tri-specific antibodies | Liquid formulations |
TECHNOLOGY & METHODS
- Molecule developability
- Hot spot analysis (primary sequence based manual or in-silico prediction)
- Forced degradation
- Post translational modification and impurity characterization (high resolution LC-MS)
- Stability and solubility predicting assays
- Colloidal and conformational stability
- A2, B22, kD determination by high throughput DLS and SLS analysis
- Tm, Tagg by capillary DSC and DSF
- ΔG by ICD
- Protein content analysis (UV/Visible)
- Absorbance spectrophotometry (microfluidic, microplate, cuvette)
- Slope spectroscopy (SoloVPE)
- Size variants (aggregates and fragments)
- SEC-UHPLC and SEC-HPLC (PDA, FLR, CAD, and QDa detectors)
- High throughput and high-resolution CE-SDS (microfluidic chip and capillary based)
- Charge variants
- IEX-HPLC (cation and anion exchange)
- High throughput and high resolution icIEF (capillary)
- CZE (microfluidic chip)
- Potency assay by binding ELISA, BLI and ITC
- Subvisible particle characterization
- MFI, BMI, LO and optical and florescence microscopy
- Advanced biophysical protein characterization
- Molecular Size by EAF4, AUC
- Secondary structure by DSC, CD
- Biochemical product characterization
- Solution pH, viscosity, density, and osmolality
- Thermal analysis – Tc, Teu, Tg’ with mDSC, FDM, DTA and impedance analyzer
- Residual moisture by KF
- Automated bioprocessing
- Microvolume liquid handing (dilution, dispensing, transfer – plates, tubes, vials)
- Buffer exchange (plate, tube)
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 formulation development services.
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