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02.23.21 Cleaning Of Multipurpose API Plants: 9 Rules To Follow
Orphan drugs are notorious for their high costs and risk factors, which are attributed to smaller patient pools and higher development and launch costs.
Attend this webinar to learn more about key trends that are causing the rise of orphan drug indications, fast-tracking early development phases that will lead to commercial success, and more!
By Grant Mordue
Cleaning validation continues to be a hot topic during regulatory inspections and industry discussions. The cleaning required in an API plant between one manufacturing process and the next can present a huge challenge, particularly when multipurpose plants are used.
Effectively Managing Data In Process Development
By Alexander Kele, Senior Global Product Manager – Digital, Cytiva
The primary role of a process development (PD) scientist is to develop robust processes that can successfully transition from laboratory scale to a safe and reliable commercial manufacturing plan. Data management plays a critical role in doing this, as the decisions process developers make about critical quality attributes, process parameters, yield, purity, and other factors are based on information collected from a wide range of sources. Traditional ways for capturing, storing, querying, and managing data are time-consuming, prone to error, and can hinder collaboration. They also make it harder to find and access data already created.