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
A QbD Approach To Freeze Drying Of Cytotoxic Compounds
Quality by Design (QbD) is a systematic approach to ensure that the quality of the product is built into production processes from the outset, rather than being tested once development has commenced. By Dr Kevin Ward
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
Hydrogen Peroxide Decontamination: Vapor Vs. Aerosolized Systems
When facing a microbial contamination challenge, hether from multidrug-resistant organisms in a hospital or in bio-pharmaceutical production facilities, not all hydrogen peroxide-based decontamination systems are the same.
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.