Product Characterization
At our company, we understand the pivotal role that accurate and comprehensive product characterization plays in biopharmaceutical development. Our services in this domain encompass a wide range of analytical techniques, including:
- AUC (Analytical Ultracentrifugation)
- Cryo-EM (Cryo-Electron Microscopy)
- DSF (Differential Scanning Fluorimetry)
- Mini-TEM (Transmission Electron Microscopy)
- Capsid ELISA (Enzyme-Linked Immunosorbent Assay)
- Peptide Mapping
- Sanger Sequencing
- Intact Mass Analysis
- ddPCR (Droplet Digital PCR)
- DLS (Dynamic Light Scattering)
- CE-SDS (Capillary Electrophoresis - Sodium Dodecyl Sulfate)
- SEC/RP-LC-FLR (Size Exclusion Chromatography/Reversed-Phase Liquid Chromatography with Fluorescence Detection)
These advanced techniques enable us to perform biological, physicochemical, and biophysical characterizations of biologics and viral vectors with unparalleled precision and depth.
QC Analytics
Quality Control (QC) analytics are foundational to ensuring the integrity, safety, and efficacy of biopharmaceutical products. Our company excels in providing comprehensive QC analytics services, including:
- Method Development: Tailored methodologies focusing on ultra-sensitive approaches crucial for gene therapies.
- Analytical Release Testing: Utilizing validated AAV and recombinant protein platform kits for robust data supporting regulatory compliance.
- Stability Studies: Expertise in designing and executing stability studies to assess product shelf-life and behavior under various conditions.
- Low Endotoxin Recovery Studies: Specialist knowledge in addressing critical challenges related to endotoxin recovery in biopharmaceuticals.
- Regulatory Support: Assistance in authoring CMC (Chemistry, Manufacturing, and Controls) sections for regulatory submission dossiers, ensuring compliance with global regulatory standards.
