11.06.24 -- Regulatory Considerations For The mRNA Platform

Plasmids, essential in biologics manufacturing, pose challenges in their development and scale-up due to difficulties integrating and optimizing them with the appropriate cell lines during process development.

Discover the essential FDA guidance on Data Monitoring Committees (DMCs) in clinical trials, highlighting their pivotal role in protecting patient safety and ensuring unbiased decision-making.

This panel discussion provides valuable insights into the future of clinical manufacturing, including regulatory hurdles, industry-regulator partnerships, and strategies for successful drug development.

One way to address risk related to product quality is by implementing a Question-based Review approach. Read on to learn about this approach and its advantages.

Review FDA guidance and strategies for executing gene therapy development programs, specifically for primary mitochondrial diseases (PMDs).

Explore the relationship between a Contamination Control Strategy (CCS) and the development of a robust cleaning and disinfection program for cleanroom environments.

Maintaining a cleanroom facility that remains safe for your workers – and where the therapeutics they produce remain safe for patients – can ease your compliance concerns.

Learn how to prepare for the EU Health Technology Assessment Regulation (HTAR), effective January 2025, to ensure a successful product launch.

This guide offers life sciences professionals valuable insights into the reasons behind FDA recalls, their consequences, and how innovative solutions can help companies avoid them.

Delve deep into the details of Chemistry, Manufacturing, and Controls and Critical Quality Attributes, which play an important role in gene editing.