07.17.26 -- Does The FDA's Plausible Mechanism Pathway Revolutionize The Way All Risks Are Analyzed?

Early collaboration with an expert partner streamlines HME projects through optimized formulation, strong scale‑up, solid analytics, and adaptable technologies that boost performance.

Reliable temperature‑controlled storage, monitoring, and safeguards keep materials stable from fill to patient, protecting quality, preventing degradation, and ensuring safety throughout the cold chain.

Watch to gain insight into the crucial role of maintenance in ensuring the ongoing optimal performance, reliability, and longevity of your inspection systems.

Discover a solution that ensures particularly efficient and reliable vertical and horizontal form fill and seal machine labeling.

Learn about the process conditions and protocols that were chosen as optimization targets and the resulting improvements to ADC production and purification that assessing these parameters provided.

Programs often stall moving to GMP due to fragmented workflows and knowledge gaps. Aligning teams and integrating development with execution, via continuous data, sustains momentum and reduces risk.

The revised Annex 1 focuses on harmonizing regulations across the pharmaceutical manufacturing industry, prompting the pharmaceutical industry to strategize to achieve the best compliance method.

Find out why it is critical that OEMs see and understand the benefits of taking time to build a mold or create automation more robustly to achieve long-term savings and higher annual production.

Rising Annex 1 demands are pushing facilities to rethink contamination control. See how RABS retrofits offer a practical path to compliance, combining effective containment and faster implementation.

Sterile fill–finish is a critical, tightly regulated stage for biotechs, demanding strong contamination control, smart CDMO selection, and awareness of capacity, scalability, and regulatory hurdles.

Examine how switching to a single-unit dose nasal sprayer carton reduced one company's material costs and significantly improved environmental sustainability throughout the product lifecycle.

What is critical when choosing a CDMO as a partner for HPAPI development and manufacturing? Brian Haney breaks down the key questions, controls, and expertise every innovator should evaluate.

Watch to see how 780 human Liver-Chips were assessed for their ability to predict drug-induced liver injury from small molecules.

Achieve seamless scale-up and process versatility by utilizing multi-shaft mixing technology. Balance high-shear dispersion with vacuum integration to optimize complex formulations.

Read 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.

Safeguarding drug quality requires robust stability testing, yet legacy systems often hinder compliance. Explore how modern digital workflows eliminate manual errors and streamline study management.