02.09.24 -- Driving Pharma/Biotech Capacity With Smart Manufacturing

Gain insight into each development stage and explore best practices that will help achieve your project goals on time and within budget.

Establishing and utilizing quality metrics is essential for the pharma industry's future success. Learn how to identify meaningful metrics and appropriately measure quality to make better business decisions.

Here, we discuss the relationship between the CCS and PUPSIT, highlight the role of sterilizing-grade filtration in the control strategy, and talk about how this can change throughout the product life cycle.

Learn about the critical changes in the Annex 1 guidance from a process equipment provider's perspective, several areas where process and product change could take place, and more.

Follow our discussion on non-heat-sensitive aqueous liquid product sterilization and the use of the overkill and bioburden/BI methods.

With regulatory requirements and GMP recommendations trending toward less human interaction and more robotic automation, robotics is the way of the future for the ATMP industry.

Examine why it is important to conduct software validation on any updated software and the role that automation can play in transforming your validation process.

Explore some of the more challenging aspects surrounding in-use testing for parenteral delivery along with potential strategies to address these issues.

Pharmaceutical manufacturing is highly regulated. Learn about what a vaccine is, how it works, the approval process, and how some vaccines can be fast tracked through the entire process.

CMOs and CPOs currently face significant challenges, including strong competition, cost pressure, and more. Learn why being agile, flexible, and responsive is bound to pay off.

Unearth why defining meaningful biomarker endpoints has become more nuanced than just figuring out whether the protein of interest is being proliferated or silenced.