04.18.25 -- Stage 3a: The Pinnacle Of Process Validation Advancement

Predicting blending quality doesn't have to be a guessing game. Learn how to leverage virtual prototypes to make informed decisions and minimize costly trial-and-error in tablet manufacturing.

How do we identify the right evidence efficiently? Early network mapping can help manufacturers balance a focused scope with the need to conduct indirect treatment comparisons.

Advanced therapies present challenges when it comes to scaling up production. Explore how collaboration, investment in R&D, and process optimization are paving the way for new treatments.

Uncover the reasoning behind the increasing demand for cleanroom technology as well as the advantages modular cleanroom design brings to the sterile processing of complex therapies.

Discover a screening process to quickly assess HME feasibility that yields more accurate predictions for API loading and degradation while saving material and time compared to traditional approaches.

Ensure product quality and patient safety by examining the FDA's draft guideline on Computer Software Assurance that emphasizes a risk-based approach to streamline software validation.

Cutting-edge nanotechnology is now emerging, able to address bioavailability challenges and deliver higher drug loads in more patient-friendly formats with fewer and smaller pills and easier regimens.

FDA 483 findings frequently cite a lack of data integrity, process adherence, and quality control. Find out why these issues persist and the significant risks they pose to pharmaceutical manufacturers today.

Watch as experts provide insight into the challenges of HPAPI manufacturing and offer proven strategies for achieving the flexibility required for small-batch production.

Examine this cost-effective, efficient alternative to traditional Protein A resin chromatography for mAb production to enhance productivity and reduce costs.

Artificial Intelligence (AI) is becoming more prevalent today and will play a crucial role in the future. Review the latest AI trends revolutionizing quality management systems in life sciences.