18. December 2015
Pharmaceutical formulations have to fulfil various requirements with respect to their intended use, either in the development phase or as a commercial product. New drug candidates with their specific properties confront the formulation scientist with industrial challenges for which a strategy is needed to cope with limited resources, stretched timelines as well as regulatory requirements. More
06. September 2015
Pharmaceutical excipients have different functions within a drug formulation, consequently they can influence the manufacturability and/or performance of medicinal products. Therefore, critical to quality attributes should be kept constant. Sometimes it may be necessary to qualify a second supplier, but its product will not be completely equal to the first supplier product. More
30. July 2015
A key challenge of manufacturing is variability. Variability is caused by many operational and human factors including human error, environment, wear and tear, variability in raw materials and active ingredients, and unclear procedures. It could also result from product and process design, for example, due to insufficient raw material controls and poorly defined processes. More
09. June 2015
Highlights • Qualification of entire processes based on CQAs of the final product (excipient). • Use of analytical methods (Raman, X-ray- and laser diffraction) with MVDA. • The value of such combined strategy is to produce a better diagnostics of quality. • Evidence-driven diagnostics of which process delivers a more consistent end-product. • Strategy for a risk-based supplier qualification using an analytical data matrix. Read more
03. May 2015
Event Description Drug delivery strategy plays a major role within the future potential success of your product. Whether nurturing a new compound or developing a line of generic products, choosing the most effective delivery strategy can open the door to both opportunities, and hurdles. According to Markets and Markets, the drug delivery technologies market will eclipse $224 billion by 2017. http://curtiscoulter.com/event/drug-delivery-strategy-advanced-mechanisms-product-design-2/