Product Characterization and QC Analytics
Product Characterization and QC Analytics Services
Pharmaron’s Gene Therapy team provides analytical capabilities for analysis of viral vectors and proteins from early phase to market authorization. Our analytical toolkit supports biological, physicochemical and biophysical characterization of CGT product modalities and addresses the unique challenges presented by advanced therapies.
Our team utilizes state-of-the-art analytical automation to increase sample throughput for process development and characterization studies. We have extensive experience of reporting and presenting analytical data to regulatory agencies in the USA, Europe, Japan, China and elsewhere.
Capabilities
Product Characterization
- World class expertise in Gene Therapy analytical characterization and CQA assessment
- Advanced analytical toolkit for product characterization, comparability and forced degradation studies
Analytical Method Development
- Method development with focus on using ultra-sensitive and small volume methodologies to tackle the difficult challenges faced with Gene Therapies
- Significant phase-appropriate method validation and method transfer
Cell-based Bioassays and Molecular Biology
- Droplet digital PCR capabilities providing the most accurate and best in-class data for Gene Therapies
- Optimization of platform analytics and development of bespoke assays including gene expression/editing and functional potency assays for release, stability and in-process analysis
QC Analytics
- Full range of analytics to support GMP Analytical and Microbiology testing in line with current EMA and FDA guidance
- Method Lifecycle Management including Method Validation and Transfer
- Reference standard qualification and characterization
- Design and justification of phase appropriate product release specifications
- Critical starting materials, drug substance and drug product release testing
Stability and Forced Degradation Studies
- ICH and bespoke stability study design, execution and shelf-life assessment
- Design and execution of forced degradation studies
- Critical starting materials, drug substance and drug product release testing
Additional Capabilities
- Specialist knowledge in low endotoxin recovery studies
- AAV and Plasmid analytical platform
- Identification and risk assessment of critical quality attributes
- Authoring CMC sections for regulatory submission
- Low volume analytics
