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Full Development of Manufacturing Process
- Developed and scaled up Pichia fermentation process.
- Developed and scaled up recovery and purification process.
- Developed analytical methods and formulation.
- Significant milestones
- Mar, 2007 - Receipt of cell line.
- Apr, 2007 - First 10L fermentation
- Sep, 2007 - Begin pre-clinical manufacturing campaign (8 production runs at 100L fermentation scale)
- Jan, 2008 - cGMP manufacturing
- Feb, 2008 - Drug substance released.
- Mar, 2008 - Fill/Finish (outsourced to third party), drug product released
- Summer 2008 - Start of phase 1 clinical trials
Monoclonal Antibody Intravenous Liquid Formulation
- Designed and executed Preformulation studies utilizing statistical DOE to determine the solubility limit and to evaluate the effect of various formulation conditions on conformational, thermodynamic, and chemical stability of the antibody.
- Designed and executed Forced Degradation studies to elucidate degradation pathways and establish various analytical methods as stability-indicating.
- Developed an optimized Final Dosage Form including formulation components, container/closure system, and fill volume.
- Developed and qualified Analytical Methods for characterization and release.
- Designed and executed Real-time and Accelerated Stability studies to support shelf life of clinical trial material.
Monoclonal Antibody Subcutaneous Liquid Formulation
- Re-formulation of low concentration intravenous product in Phase II clinical development.
- Designed and executed Preformulation studies utilizing statistical DOE to determine the solubility limit and to evaluate the effect of various formulation conditions on conformational, thermodynamic, and chemical stability of the antibody. Achieved concentrations in excess of 200mg/mL.
- Designed and executed Forced Degradation studies to elucidate degradation pathways and establish various analytical methods as stability-indicating.
- Developed an optimized Final Dosage Form including formulation components, physico-chemical properties such as osmolality, container/closure system, and fill volume.
- Developed and qualified new Analytical Methods for characterization and release. Re-qualified existing methods for the new formulation.
- Designed and executed Real-time and Accelerated Stability studies to support shelf life of clinical trial material.
Multi-Protein Lyophilized Formulation
- Re-formulation of product in Phase III clinical development
- Designed and executed Preformulation studies utilizing statistical DOE to evaluate the effect of various formulation conditions on conformational, thermodynamic, and chemical stability of the drug.
- Designed and executed Forced Degradation studies to elucidate degradation pathways and establish various analytical methods as stability-indicating.
- Designed and executed Formulation Development studies to evaluate the suitability of various bulking agent, drug, and excipient concentrations.
- Developed appropriate Lyophilization Cycle to result in rugged, elegant cakes with optimal reconstitution properties.
- Designed and executed Accelerated Stability studies to demonstrate acceptable shelf life.
- Developed, transferred, and validated Analytical Methods for release of Phase III and commercial supplies.
- Designed and executed Real-time and Accelerated Stability studies to support shelf life of clinical trial material.
Fusion Protein High Concentration Lyophilized Formulation
- Designed and executed Preformulation studies to determine the solubility limit and to evaluate the effect of various formulation conditions on biophysical and chemical stability of the fusion protein.
- Designed and executed Forced Degradation studies to elucidate degradation pathways and establish various analytical methods as stability-indicating.
- Developed and qualified Analytical Methods for characterization and release.
- Developed appropriate Lyophilization Cycle to result in rugged, elegant cakes with optimal reconstitution properties.
Peptide in Dermal Gel Formulation
- Designed and executed Preformulation studies to evaluate the effect of various buffers, pH conditions, antioxidants, and gelling agents on peptide stability.
- Designed and executed Formulation Development studies to evaluate the effect of various formulation conditions on viscosity and release of drug from the gel.
- Developed and qualified Analytical Methods for characterization and release.
- Characterized impurities via LC-MS.
- Designed and executed Accelerated Stability studies.
Microsphere-Protein Inhalation Formulation
- Designed and executed Preformulation studies to evaluate the effect of pH, ionic strength, and temperature on the solubility of the protein and the microsphere backbone. Also evaluated the effect of pH, concentration, and ionic strength on protein conformation.
- Designed and executed Binding Studies to evaluate the nature of interactions between protein and microsphere under various conditions and the effect of binding on protein conformation.
- Developed and qualified Analytical Methods for characterization and release.
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