Development
ËÄÉ«AV offers a full range of development services in particle engineering to provides optimal solutions for your drug product.
ËÄÉ«AV has more than a decade of accumulated experience and knowledge in Particle Engineering process development and scale-up. Our multidisciplinary development teams combine science and management to reduce, risk and time-to-market. Chemical engineers, pharmaceutical scientists, material scientists, chemists, analytical chemists, and others, work side-by-side toÌýdevelop the most innovative solutions for your specific needs through the best use of the most up-to-date technologies, and practices in drug product development.
ËÄÉ«AV performs: a) proof of concept studies using the absolute minimal quantities of the drug substance Ìýb) full process industrialization and c) commercialization. We make use of our proprietary framework EDaM (Excellent Development and Manufacturing) toÌýensure that early on in the process development, we are making the right choices concerning the long term commercial manufacturing strategy as well as product lifecycle management. Our development tools are constantlyÌýevolving to provide an enhanced understanding of the product and process. Some of our tools include mechanisticÌýmodeling, scale-up science, statistical design of experiments, respective analysis andÌýprocess analytical technologies (PAT).
As an integrated service provider ËÄÉ«AV can manufacture your drug substance all the way to commercial supplies and perform formulation development and production of early clinical supplies.
Learn more about our technologies, with the following articles by ËÄÉ«AV's experts:Ìý
Scale-up of spray dried amorphous solid dispersions
Published in European Industrial Pharmacy, December 2013
Spray congealing: applications in the Pharmaceutical IndustryÌý
Published in Chemistry Today, September/October 2013
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Development and Manufacturing of Inhalable Drugs Under a QbD Approach
Quality by Design helps understand key critical inhalation process parameters