06.30.26 -- Building PFMs For Scalable Manufacturing

Robotic, gloveless isolators redefine aseptic filling by meeting Annex 1 standards. Discover how this approach ensures product integrity through automation for clinical and commercial manufacturing.

Reconstructed nasal epithelium and CT-based 3D nasal casts provide more predictive, physiologically relevant models for assessing nasal drug delivery, improving accuracy in formulation development.

Explore the urgent need for sustainability in small molecule API manufacturing, as well as reveal regulatory drivers, green chemistry innovations, and practical strategies to reduce emissions.

Ensuring transdermal patch packaging integrity is critical for safety and efficacy. See how advanced methods deliver precise, reliable leak detection, outperforming traditional approaches.

We share important factors to consider when weighing your contract service provider options. These “Three Cs” can indicate whether a service provider has the capabilities desired by a drug sponsor.

Integrated, regulatory‑ready analytics help accelerate development, strengthen submissions, and ensure consistent product quality throughout the pharmaceutical lifecycle.

Uncover the future of in vitro modeling at the Queen Mary+Emulate Organs-on-Chips Centre and unlock new possibilities in the field of predictive medicine.

A new regulatory chapter requires holistic, real‑world testing of injectable systems, mandating full‑system validation with actual drug products and prioritizing patient‑centric performance and safety.

Meeting the growing need for oligonucleotides means having the right tools. Learn about the nine indispensable components, such as synthesis columns and C&D systems, for your facility.

Creating a robust contamination control strategy is essential for pharmaceutical manufacturing. Find out how to align risk management and technical controls to ensure lasting regulatory compliance.

Every drop of high-value biologic lost in fill finish is money left on the table. Gain insight into practical strategies to protect your yield.

Delve into how early device strategy and integrated planning can streamline development, reduce risk, and accelerate your path to commercial success.

AI is revolutionizing CQV in life sciences by automating documentation, enabling real-time monitoring, and driving predictive quality to boost efficiency and compliance across validation processes.

Safeguard living medicines with a tailored facility design strategy. Evaluate workflows with this six-dimensional model against your CCS for a holistic look to inform your decisions.

Asher Biotherapeutics was seeking a CDMO that could handle Phase 2 through to commercial production, as well as taking early-stage projects in its pipeline all the way through their lifecycle.