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Autumn 2013

   
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News and Press Releases

Vetter further expands its Development Service with new site in Austria

CDMO addressing growing customer demand Investment in additional clinical filling options in Europe Planned ‘go live’ in 2021 Ravensburg, Germany and Rankweil, Austria, July 8, 2020 – With biopharmaceutical development heavily focused on specialized therapeutics, drug sponsors are increasingly turning to expert outsourcing partners to meet growing demand for complex fill and finish solutions. Vetter, a leading global Contract Development and Manufacturing Organization (CDMO) is further investing in additional capacity to meet that growing global demand with the purchase of a clinical manufacturing site located in Austria.
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White Papers

Backward Thinking: The Reverse Engineering of A Pressurized Metered Dose Inhaler

Development of a generic equivalent to a current marketed pressurized metered dose inhaler (pMDI) product brings immense challenges. Thorough analysis is critical to gain a comprehensive understanding of the physical attributes and pharmaceutical performance of the reference marketed product. Many factors need to be assessed, understood and combined in order to successfully develop a generic pMDI which will meet the regulatory and quality requirements as an equivalent product in the anticipated target market. Significant information about the reference marketed product can be obtained from a thorough review of published literature, specifically the Summary of Product Characteristics (SPC) and Patient Information Leaflet (PIL). Additionally, baselining the reference marketed product for pharmaceutical performance offers a working target specification for in-vitro correlation. It will ensure the smoothest possible path to commercialization and maximize return on investment. In addition, baselining of the reference marketed product is done to understand batch-to-batch variability and product performance over the stated shelf life to establish targets for critical quality attributes (CQAs), which can be applied to the generic equivalent pMDI.
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Industry Events

World Vaccine Congress Europe

18-21 October 2020, Barcelona, Spain

The World Vaccine Congress is an award-winning series of conferences and exhibitions that have grown to become the largest and most established vaccine meeting of its kind across the globe. Our credibility is show through the prestigious scientific advisory board that spend months of hard work creating a new and topical agenda, year on year.
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