Poorly soluble drugs for oral administration present unique formulation challenges, particularly during early development. Formulation in a lipid-based carrier can be a feasible approach, but usually requires extensive testing to find suitable excipient combination.
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The focus on accelerated development of new modalities for advanced therapies and challenges with complex drug candidates has driven the adoption of novel concepts and technologies in pharmaceutical development and manufacturing.
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on24
In this webinar, Anders Högdin, Senior Sales Director at Recipharm discusses the common challenges companies encounter during upscaling. He also outlines the key considerations during the medicinal and process chemistry planning phases, the regulatory requirements and the steps companies can take to streamline the process.
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Bio Pharma Asia
Companies often experience regulatory challenges during an inspection of aging facilities, requiring them to initiate projects to optimize product protection and updating to current standards for classified areas for biopharma manufacturing. For a long time, the company response has been to improve the existing classified areas or maybe even upgrading to a higher grade of classification. However, it may be more appropriate, and improve product protection, to instead implement the use of closed system processes and downgrade room classification during these facility renovation projects. If closed systems are fully utilized, then a CNC space can be used. As well as reducing the complexity of operations, this will reduce capital and operating costs.
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