Newsletter | November 17, 2020

11.17.20 -- Process Characterization: Ready For The FDA?

Industry Insights
Process Characterization: Ready For The FDA?

Realizing the benefits of process characterization requires proper planning and application of a comprehensive process characterization strategy.

Understanding The CMC Regulatory Landscape For Cell And Gene Therapy Products

The curing potential of cell and gene therapies is driving the industry’s passion and motivation to gain a better understanding of the evolving regulatory guidelines for these products, in order to bring them to market faster.

Why, Why, Why… ELISA? A Look At The Benchmark HCP Assay

Biologics developers and manufacturers demand an accurate and reliable assay for host cell protein (HCP) quantitation. Let’s take a close look at why analytical scientists turn to the ELISA, and how it fits into process development.

Engineering Approaches To Respiratory Drug Delivery: Mannitol Case Study

Spray drying and jet milling are commercially viable engineering processes for the development of respirable drug products. This article presents a case study that explores the material and performance properties of spray-dried and jet-milled mannitol for respiratory delivery of crystalline mannitol. Read our article to learn more.

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