Analytical Services
Advanced Analytical Development and Testing for Biologics
Pharmaron provides comprehensive analytical development and testing services for biologics, tailored to support each stage of development from discovery to commercialization. Our capabilities include physicochemical and biological characterization, method development, qualification and validation, release, stability, forced degradation studies, and regulatory-compliant reporting. These services are designed to meet global standards and support seamless integration into your development programs.
Core Analytical Capabilities
- Molecule Characterization: Structural and physicochemical analysis, including primary, secondary, tertiary, and higher-order structural analysis like sequence coverage, glycosylation profiling, and aggregation studies
- Method Development: Bioassay and physicochemical method development, qualification, and optimization, validation, and lifecycle management
- Process Support: Analytical studies for process characterization (PC) and validation (PV) to ensure manufacturing consistency
- Release and Stability Testing: Phase-appropriate testing for appearance, potency, purity, safety, and stability under ICH conditions
- Regulatory Reporting: IND-enabling data and technical reports tailored for CTD submissions
Capabilities
Pharmaron’s analytical expertise focuses on characterizing critical quality attributes (CQAs) such as purity, structural integrity, and biological activity. Using advanced methodologies, we ensure regulatory compliance, product stability, and seamless progression through biologics development stages.
Analytical Testing
- Release and Stability Testing
- Appearance: Color, clarity, physical state
- Identity: Peptide mapping
- Potency: Binding assays, protein concentration
- Purity: SEC-HPLC, CE-SDS, IEX/CEX, icIEF
- Safety: Bioburden, endotoxins, sterility, and mycoplasma detection
- Impurities: Host Cell Protein (HCP), Host cell DNA, Protein A, residual Protein A, sub-visible particles
- Stability: Real-time and accelerated testing to define shelf life
In-Process Assays
Pharmaron’s in-process assays deliver real-time insights to maintain quality and optimize biologics production
- UPLC for Biochemical Profiling: Detecting impurities, aggregates, and assessing stability
- HPLC for Precision Analysis: Monitoring molecular weight and glycosylation patterns
- DSP Performance Metrics: Evaluating downstream parameters like yield and purity for optimal recovery
Biological and Structural Characterization
- Primary, secondary, tertiary, and higher order structural characterization: Molecular weight, glycosylation profiling, post-translational modifications
- Biological: FcγR binding assays, ADCC/CDC activity, and enzymatic assays
- Bioassays: ELISA-based and cell-based potency assays for functional activity
Regulatory and Compliance Support
Pharmaron’s regulatory expertise ensures seamless progression through global compliance requirements. Our key services include:
- CTD Preparation and IND Submission: Comprehensive technical documentation for regulatory filings
- Stability Studies: Real-time and accelerated testing under ICH guidelines
- Risk Mitigation: Proactive identification and resolution of compliance gaps
Contact Pharmaron for Analytical Support
Pharmaron’s expertise ensures reliable, regulatory-compliant data at every stage of biologics development. Let us partner with you to deliver technical excellence and accelerate your program’s success.
