The concepts and methods of Quality by Design (QbD), which the automobile, airline, and electronics industries have utilized to enhance the quality and reliability of their finished products, are gaining traction in pharmaceutical manufacturing. QbD enables pharmaceutical and biotechnology companies to identify, analyze, and control the sources of variation in manufacturing processes that can lessen the quality of drugs and other therapeutic products.
The goal of every pharmaceutical developer is to create quality products which generate consumer satisfaction, require low cost, and have low risk. Quality starts from the moment of conception of an idea and continues throughout production.
As the pharmaceutical industry implements PAT and QbD, their symbiotic nature becomes increasingly obvious. Both are catalysts towards the longer term goals of continuous operation and real-time release — the realization of a transformed way of working. This article reviews changing practice within the pharmaceutical industry using the example of real-time particle size analysis to explore the analytical solutions needed and the benefits they deliver. By Malvern Instruments
Setting meaningful and realistic specifications is an essential element of Quality by Design (QbD). Well-defined specifications control product performance since they derive from correlations between clinical behaviour and the variables measured routinely during processing and for QC. This paper examines the process of setting specifications, taking as an example particle size, a critically important parameter for many pharmaceutical formulations. By Malvern Instruments
QbD is increasingly required in our industry, but there are still gaps in understanding how QbD applies to the biomanufacturing process.
Competition in the generics market has never been greater. At a time when many of the most successful drugs are reaching the patent cliff, opening the floodgates for generic substitutes, generic companies are rushing to target the best candidates and enter the market first.
Formulation and automated manufacture of capsules for early phase dose escalation clinical trials can be costly and wasteful. By Lisa Z Crandall