02.21.23 -- Best Practices For Effective Quality Documentation Processes In Drug Manufacturing

There is always a balance between speed and compliance, while others struggle to adopt new technologies because of the uncertainty of how to comply with FDA regulations. Needless to say, developing a quality and compliance posture that meets the needs of both masters (business stakeholders and auditors) is a tall order. In this piece, we will chronicle the trends that successful quality and compliance teams adopt to keep pace with the speed of discovery.

A 360-degree approach entails full CMC development and analytical release testing in support of biopharmaceutical products in development and in clinical trials — all from one partner.

Explore the benefits of using mRNA for vaccines and therapeutics, and learn how to address some technical, intellectual property (IP), and cost considerations, particularly when considering commercial production.

There is a significant history in determining how to deliver all of the new plate types; much of the work that made possible the mRNA therapeutics and vaccines goes back to the siRNA space. Most people are relatively familiar with lipid nanoparticles. If you inject a lipid nanoparticle that’s encapsulating a nucleotide, it traffics predominantly to the liver, and it works very robustly.