Materials science is now helping pharmaceutical companies to standardize and control areas such as drug form and manufacture to deliver new products more quickly and with greater quality.
QbD starts with an understanding of the quality target product profile. This allows potential critical quality attributes (CQAs) to be established and a risk assessment performed.
What can you do when the identification method defined by the USP monograph does not provide clear guidance? The authors decided to improve the method with a Quality by Design (QbD) approach.
With continuous manufacturing, it is possible to monitor product quality continuously, and make adjustments in real time to keep the product in spec.
Manufacturers safeguard biologic materials during the development process through a set of measures commonly referred to as the “Safety Tripod.”
Continued Process Verification (CPV), Process Analytical Technology (PAT) and Quality by Design (QbD), are driving pharma to improve product and process quality and efficiency.
Porosity is a good prediction of how liquids enter into the tablet matrix, and the expectations can be validated by experiment. Dissolution rates do not exclusively depend upon porosity; other predictors are also valid including solubility, surface area, and particle size. In addition to carrying out dissolution testing, establishing porosity, surface area and other characteristics are key to establishing the optimal dissolution rate.
In the pharmaceutical world, particle size analysis has traditionally been the method of choice to “characterize” raw materials.
Products packaged for consumer use by the pharma industry go through a battery of tests related to how the user applies the product.
Every component used in biopharmaceutical processing — large or small — is pivotal to the ultimate goal of delivering safe and effective medication. Advancements associated with tubing may not necessarily be perceived as revolutionary, but there is an ability to innovate in this space. To deliver cleaner materials and actively mitigate risk in biopharmaceutical manufacturing, evaluation of single-use tubing based on the three development principles in this article should take place.
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