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
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.
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
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
Does Rheology Matter To Manufacturing
You bet it does, whether or not manufacturing realizes it. Rheology is the science that looks at how materials flow. Whether the product is a liquid, cream, paste, or solid, the manufacturing process must transfer raw ingredients through multiple stages to create the finished product. By Robert McGregor, Global Marketing and High End Product Manager, Brookfield Engineering Laboratories, Inc.
Using Quality by Design (QbD) For Process Optimization Of A Novel Oral Solid Dosage Form
As stated in the International Conference on Harmonisation Harmonised Tripartite Guidance on Pharmaceutical Development, ICH Q8 (R2), “The aim of pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product.” By Joe Cobb, R. Justin Brett, Michael D. Ruff, Anthony Berry and Robert Epps