01.25.24 -- Need To Improve Your Change Management? Regulators Can Help With That

When developing a nasal delivery program, a partner with experience in development and manufacturing techniques who can see a program through small-scale clinical to commercial supply is crucial.

A strong CMO partnership can help you achieve optimal results quickly and without compromising quality. Explore expert insights from a successful API development project during the pandemic.

Surplus and idle equipment can lead to decreases in workspace and work efficiencies for a manufacturing site. Learn how you can get paid for them and clean up your workspaces.

Learn about advances in the development of a one-part chemically defined microbial medium to simplify workflows and achieve high-density cultures for recombinant protein or plasmid production applications.

A panel of product development experts examines blind spots that can plague early development strategies, as well as important considerations when navigating the path toward an IND submission.

Gain a better understanding of the challenges associated with bioreactor scale-up when determining which CDMO is a good fit for your needs.

Risk-based monitoring increases overall trial oversight by balancing “must do” data collection and “nice-to-have” data against site and patient burden — and, more important, patient safety.

Discover how you can make strategic decisions faster by harnessing the power of the data you generate through a digital data backbone.

Standardization and flexibility in aseptic filling were thought to be mutually exclusive. But what if there was a standardized system with flexibility built into the aseptic process, so you didn’t have to choose?

See how knowledge of microbial processes and process characterization understanding can be used to design targeted BLA programs while managing the risks of achieving a quick regulatory pass.

Learn about an ongoing partnership between a German-based contract packaging company and a global manufacturer of production inspection systems that provides pharmaceutical packaging solutions.