CMC (Quality) Analytical and Stability Studies
- Product physiochemical and functional characterization
- Preparation and characterization of product degradants
- Characterization and control of process impurities (e.g. DNA and HCP)
- Host cell protein reagent development and ELISA validation
- Phase-appropriate analytical comparability studies for process changes
- Phase-appropriate method life cycle studies (including in vitro bioassays):
- Optimization/Re-optimization of problematic methods
- Qualification (methods for characterization, comparability, biosimilarity studies)
- Verification (original compendial methods)
- Validation (non-compendial, or modified compendial, methods)
- Tech transfer (lab to lab)
- Method bridging (technology to technology)
- Reference standard characterization, bridging and stability protocols
- Forced degradation studies for establishing product stability profile and selection/validation of stability methods
- ICH stability studies (target, accelerated and stress conditions)
- Biosimilar/originator product analytical similarity studies
- Immunogenicity screening assay development and validation
- ADA neutralization assay development and validation
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Laboratory Quality Practices and Inspections
- Pre-Approval Inspection (PAI) readiness audits for analytical and stability CMC
- Remediation of GLP and GMP inspection observations
- Due diligence audits for potential partnerships, mergers or acquisitions
- Assessment of laboratory quality agreements with R&D and GMP contract testing organizations
- Laboratory GMP compliance checks (including Part 11 elements)
- Laboratory GLP compliance checks (including QAU monitoring)
- Analytical method tracking/trending strategies
- Gap analysis of quality practices and policies for OOS and deviations
- GMP analytical Data Integrity gap analysis and remediation
- Quality practices for R&D laboratories
- Data integrity for analytical biosimilarity studies
- Data integrity for critical non-GMP CMC studies
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