Translational Pharmaceutics and the Benefits of Real-Time Adaptive Manufacturing

Current diagnostic methods for lower respiratory specimens typically take one to two days to identify most bacterial pathogens. During that time, clinicians must rely on guideline recommendations and clinical diagnosis to guide empiric therapy, which is not optimized based on the patient’s individual pathogen. The BioFire Pneumonia Panel will provide pathogen identification in a much shorter timeframe and may allow clinicians to optimize targeted pathogen-specific therapy sooner. The BioFire Pneumonia Panel is a rapid multiplex-PCR test that identifies 33 targets, including 18 bacteria, 8 viruses and 7 antimicrobial resistance genes from lower respiratory tract specimens in about an hour. It provides semi-quantitative results (in copies/ml) for 15 of the bacterial targets. This new feature provided by multiplex-PCR testing may help clinicians and laboratorians separate colonizing from pathogenic levels of bacteria.

Economic performance could soon replace compliance as the leading quality goal for pharmaceutical companies. According to the 2019 Pharma Quality Outlook Survey, 66% of industry executives named compliance as a top goal, down 10% from last year. Meanwhile, more than one-third (39%) say that economic performance is now their top objective, a 4% increase.Join Sparta System's Steve McCarthy, VP of Digital Innovation, as he discusses key findings from this year's survey, which included responses from 161 professionals.

After years of innovative research, advanced therapies are dramatically changing the way patients are treated for a wide variety of diseases particularly for patients with rare diseases and orphan indications. New developments in advanced therapy medicinal products (ATMPs) comprising cell and gene therapy products show the potential to modify or even cure severe chronic conditions for which previously no treatment existed. As a consequence, the dynamic market for innovative therapies such as CAR-T, immuno-oncology, and gene and cell-based therapies grows across the globe. Academic institutes and biotech companies are contributing to these developments both in terms of scientific discovery and undertaking clinical trials aiming for regulatory approvals to treat specific patient populations. While we might be in a golden age of medicine due to advancements in ATMPs, innovative clinical research and development remain crucial for getting treatments to patients.

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.