09.01.26 -- Implementing And Optimizing Your eQMS

Pharmaceutical manufacturing facilities require active management and engineering expertise to balance costs, plan long-term infrastructure, and minimize production downtime.

Domestic pharmaceutical manufacturing strengthens supply chain resilience, simplifies distribution, speeds market response, and reduces risk by aligning production with key markets.

Physiologically based pharmacokinetic (PBPK) modeling advancements are helping drug sponsors mitigate risk in preclinical and clinical studies through early identification of poor absorption properties.

Disconnected systems slow investigations and delay batch release. Learn how a digitally connected execution ecosystem provides real-time context for alerts, enabling proactive control.

With most drug candidates failing before approval, researchers need better ways to predict human responses. Gain insight into how advances in human-relevant modeling are helping improve decisions.

Integrating R&D knowledge into GMP documentation ensures consistent aseptic powder fill‑finish processes by capturing material insights, defining controls, and enabling reliable manufacturing.

Review the crucial selection of the optimal solid form in  carefully achieving successful jet milling of APIs designed specifically for pulmonary administration through the pulmonary route.

Mark Benger, Site Director at Edinburgh, on solid-state characterization as an insurance policy — front-loaded work that quietly determines whether a program survives the jump from kilos to tonnes.

Compaction simulation de-risked tech transfer for a 40 mg fexuprazan tablet by defining optimal roller compaction and lubrication parameters before scale-up. See the data.

When terminal sterilization isn't an option for heat- or radiation-sensitive APIs, sterile filtration with aseptic processing protects quality. Get the technical framework.

Selecting the optimal antibody framework is critical. Discover how monoclonal and polyclonal epitope specificity impacts manufacturing complexity, batch uniformity, and long-term therapeutic efficacy.

NGS offers a sensitive, high-throughput solution for detecting adventitious viral agents (AVAs), improving biopharmaceutical safety and accelerating regulatory-compliant product development.

Adopting AI and robotics enhance sterility and regulatory compliance and enable real-time decision-making and reduce human-borne contamination, ensuring the safe production of complex therapies.