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Mechanistic Hypothesis of Toxicity: Driving Decision Making in Preclinical Translation

Mechanistic toxicity hypothesis is essential in guiding decision-making and predicting toxicities during the preclinical stages of drug development. The authors highlight the growing importance of integrating advanced technologies like mass spectrometry imaging into toxicology to enhance preclinical translation, foster innovation in therapeutic development, and ultimately improve drug safety and efficacy.

Outsourcing Hits Record Levels for All Bioprocess Platforms

Outsourcing is booming across all platforms, from fill/finish to cell therapies, as companies pursue efficiency, scale, and strategic flexibility.

New Year, Same Challenges: Pharma’s Ongoing Struggle with FDA 483s

The authors examine common FDA 483 findings and outline strategies to address and prevent regulatory non-compliance.

Single-Use Technology: Transforming Biomanufacturing Today and Tomorrow

Advanced technology platforms optimize the efficiencies and sustainability of single-use bioreactors, setting the scene for the next evolutionary step in biomanufacturing.

Digital Transformation in Pharmaceutical Manufacturing

Leveraging computerized maintenance management systems software can enhance efficiency, improve quality control, ensure accurate documentation, and strengthen data integrity.

Best Practices for Quantification of Residual Host Cell DNA with Real-time PCR

CRISPR Gene-Editing Technology in the Development of Biopharmaceuticals

Novel nucleases with diverse properties represent promising solutions, emphasizing their potential to overcome current limitations in genome editing and therapeutic delivery.

MHC-Associated Peptide Proteomics: Immunogenicity and Vaccine Design

This article looks at how the MAPPs assay works, how it integrates with other immunogenicity assays, and just how it can be flipped to help in vaccine design.

A Novel, Enhanced, and Sustainable Approach to Audit Trail Review

Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.