Patient-Centric Design: The Next Frontier In Drug Delivery
Patient-centric is one of those terms we suddenly seem to hear mentioned often. Everyone in pharma wants patients to know that it’s their comfort and well-being that are always at the forefront of development efforts for medicine and delivery devices.
WHITE PAPERS & CASE STUDIES
Be In Control Of Product Quality – Do Not Just Rely, But Understand
Past experiences have shown that too often product quality is based on sole reliance of vendor certifications, statements and promises. To diminish such reliance new technologies started to be implemented, like process analytical technologies (PAT), process controls, automation etc. often once again overexerted as the solution to all problems. Activities that supposedly result in higher product quality due to better process controls. Maik W. Jornitz, Chief Operating Officer, G-CON Manufacturing LLC
The Challenges With Real-Time Viable Particle Counters
While real-time viable particle counters offer significant potential benefits, they also present some new challenges to industry and regulators. This article will address the unique challenges associated with evaluating, testing, and validating this new family of RMM instruments.
Risk Mitigation When Evaluating Cleanroom Construction Materials
Reducing the cost of goods sold has become a focus of pharmaceutical facility, cleanroom, and process design, especially as blockbuster patents have begun to expire and generic competition has intensified. The need to minimize manufacturing costs sparked a multitude of creative ideas. By Maik Jornitz, COO, G-Con
Flexible Production Platforms For Biopharmaceutical Manufacturing
A paradigm shift in flexible biopharmaceutical production sites and process designs has been recognized in multiple scientific publications and conferences.
Monitoring Chemical Processes For Early Fault Detection Using Multivariate Methods
Multivariate Statistical Process Monitoring (MSPM) has been established as a valuable tool for ensuring reliable product quality in the process industry. However, many organizations today are still not fully utilizing its potential to make significant improvements in their production environment. By Dr Frank Westad, Chief Scientific Officer, CAMO Software
Modular Does Not Always Mean Flexible For Pharmaceutical Facilities
Lately, the pharmaceutical industry has become increasingly interested in flexible facilities. By Maik W. Jornitz, Chief Operating Officer, G-CON Manufacturing