Cancer Research & Oncology 2018

In this on-demand webinar, we discuss the key takeaways of the proposed rule, including its potential impact, if finalized, on various stakeholders, including PBMs, health plans, drug manufacturers, and pharmacies.

Hot Melt Extrusion (HME) is an established processing technology that can be used for the development of paediatric formulations. The processing of lipids via HME has been proved ideal for high drug loaded dosage forms with sustained release of drugs. The study investigates the effect of the lipid type and the food grade on the dissolution rates of extruded pellets or extemporaneous formulations.

Following the patent of the innovative “Espresso” intravenous delivery device, the Italian Biochemical Institute (IBI) “Lorenzini” commissioned Comecer to construct a filling line to meet the unique requirements of the solution. Particle Measuring Systems’ advisory team leveraged their industry and regulatory expertise to oversee the development of the aseptic filling process and the environmental monitoring system by applying proven risk management techniques. Using this case study, we provide practical insights for Quality by Design principles with input from IBI and Comecer.

After a small molecule has been identified as a viable drug candidate, substantial testing is required to assure that chemical and structural integrity are preserved throughout the drug development process to maintain its functionality. To keep a balance between quality and manufacturability, time-consuming and labor-intensive testing and analysis are required to demonstrate that chemical integrity is intact. Among the techniques used to study changes in chemical integrity are infrared and Raman spectroscopy. This webcast will discuss where efficiencies can be made in data collection, regulatory compliance, instrument qualification, method validation, and data integrity all along the development pipeline up to final quality control (QC) testing. Learn how to quickly identify changes in polymorphic structure, monitor API to excipient distribution, and troubleshoot out-of-specification (OOS) product lots, while preserving data integrity needed for audits.