Commercialization
As an FDA-approved CDMO, we have taken molecules to market in multiple regions, including USA, Europe, Japan, Canada and Australia. We work with clients to optimize chemical processes, undertake CMC gap analysis and provide many other services to support commercialization. We can provide CMC and commercialization support services as part of an existing program or as a stand-alone service.
Filed in over 23 countries!
We can perform development and manufacturing of small commercial batches and orphan drugs. We have authorizations for nearly all drug substances and are able to handle biotech products, nanocarriers, highly potent products and controlled substances.
Our Services Include:
- CMC Gap Analyses at Milestone Stages (Pre-Clinical to Clinical; Phase I to II, to III; to Market Authorization Application; Post-Approval and Long Term Manufacture)
- Process and Analytical Control Risk Assessment
- Stage-Appropriate Process Optimization
- Multivariate and Design of Experiment (DoE) approaches
- Process Mapping and Critical Process Parameter Studies
- Impurity Marker Synthesis
- Impurity Spike Fate and Purge Study Design, Execution and Interpretation
- Material Characterization & Elucidation of Structure
- Preparation for, and Execution of Process Performance Qualification (PPQ, ‘Process Validation’)
- Control Strategy Development:
- Related Substance and Process Impurities
- Residual Solvents and Elemental Impurities
- DNA-Reactive Impurities (Mutagenic or Genotoxic Impurities, ‘GTIs’)
- Solid Form Characteristics
- Technology Transfer to Client or Partner CMOs, as required
- Broad CMC Support:
- In Preparation for, During & After Market Launch
- Numerous Regions and Evolving Regulatory Landscape
- Drug Substance process upscaling with analytical support (Small Molecules / Biologics)
- Drug Product process upscaling with analytical support (Small Molecules / Biologics)
- Sterile and Non Sterile Manufacturing with analytical support
- Clinical Packaging and Logistics
