Trade Articles

Bioanalysis Considerations for CAR T-Cell Therapies

Preparing an IND submission: Here is what drug sponsors should anticipate

Comprehensive Bioanalysis of ADCs in DMPK Studies

Dissecting the Delicate Delivery Process for Ocular Gene Therapy

Utilizing Monoclonal Antibodies to Regulate Checkpoint Proteins & Boost Immune Response

5 questions drug developers need to ask when vetting laboratory testing partners

Improving Preclinical Outcomes: De-Risking Your Drug Development Program

Preparing for Preclinical Testing: A Readiness Checklist

Managing critical reagents through drug development

Bioanalysis in the Age of New Drug Modalities

Analyzing FDA guidance on DDI studies for therapeutic proteins

Bioanalytical considerations for gene and cell therapeutic products

Antibody-Drug Conjugates (ADCs): Potent Cancer Killers with PK Challenges

Examining the dominant bioanalytical methods for Oligo development

Bioanalytical method development and validation using Quanterix’s Simoa platform

Protein Biomarkers: The Correlation Between Proteins, Health Conditions and Exogenous Products

The opportunities and challenges inherent in using protein biomarkers for new drug development

Using In Vitro–In Vivo Extrapolation to Predict Human Clearance

The transition to ICH M10 and its impact on global submissions

Improving Submission Quality: Preparing For Regulatory Differences

Winning the drug development relay