Complex Biomolecules Require Analytical Evolution
The ever-increasing complexity of biotherapeutic molecules presents unique analytical challenges for developers.
Best Practices for Analytical Method Validation: Study Design, Analysis, and Acceptance Criteria
Developing analytical methods and bioassays is necessary from early on in the drug development life cycle.
Data Integrity Considerations for Vendor-Generated Data Associated with Analytical Testing
Sponsors should consider best practices for maintaining data generated during sample analysis and instrument maintenance.
Detecting Residual HCPs Demands a Holistic Approach
Gene therapy products present a unique set of challenges for the control of host cell protein impurities.
Increasing the Depth and Reliability of HCP Analysis Using TIMS-MS
Sophisticated analytical technologies are complementing traditional approaches in the identification of residual process-related impurities of biotherapeutics.
Improving IR Spectroscopy as a Tool for Biopharmaceutical Analysis
Microfluidic Modulation Spectroscopy is a recent innovation in infrared spectroscopy techniques that improves elucidation of secondary protein structure.
Prioritizing Cleaning Validation
As recent COVID-19 vaccine facility citations make clear, failure to meet cleaning and sanitization requirements puts patients, facilities, and operators at risk.
