Analytical Development
Analytical Development is fundamental to ensuring the quality and safety of biologics and biosimilars. We develop specific analytical procedures to precisely monitor Critical Quality Attributes (CQA) throughout all stages of cell line development, as well as in upstream and downstream processing.
Our team compiles a comprehensive panel of analytical methods tailored to precisely meet your project's requirements, guaranteeing robust process monitoring and product characterization.
Core Analytical Focus Areas
Process Monitoring
Quantitative parameters captured from the bioprocess (growth, titer, metabolic data).
Product Purity & Size
Techniques to monitor aggregation, fragmentation, and impurities (e.g., SEC, SDS-PAGE).
Charge & Glycosylation
Characterizing molecular modifications vital for efficacy (e.g., IEX, HILIC-HPLC).
Key Characterization Methods
We use a broad spectrum of established methods for qualitative characterization and CQA monitoring, including:
- Ion Exchange Chromatography (Charge Variant Analysis)
- HILIC Chromatography (N-Glycosylation Profile)
- Hydrophobic Interaction Chromatography (HIC)
- Size Exclusion Chromatography (SEC)
- Peptide Mapping
- SDS-PAGE and Western Blotting
- ELISA (Quantification & Immunoassay)
- In-vitro Activity Testing
- Liquid Chromatography-Mass Spectrometry (LC-MS)
We also collaborate with specialized partners to implement complementary analytical methods, such as binding studies, and advanced activity and potency assays.
Need a specific analytical method developed for your novel biologic?
Contact our Analytical Development team