Newsletter | January 24, 2023

01.24.23 -- Application Of A Novel Temperature Shift Process For Particle Engineering

Industry Insights
Application Of A Novel Temperature Shift Process For Particle Engineering

Spray drying of amorphous dispersions improves solubility and bioavailability that enables supersaturation in the intestine, driving higher rates of absorption when compared to crystalline drug forms.

Qualified Reference Standards: Setting The Standard For Product Quality

Qualified reference standards play a critical role in providing validated benchmarks to satisfy regulatory requirements pertaining to purity.

A Versatile Method For Capsule And Depth Filtration

Learn about a solution that can provide a simple, easy, and versatile method for capsule and depth filtration, allowing a quick, efficient move from cell harvest to purification.

Capture Of Bispecific Antibodies And Removal Of Product-Related Impurities

Many antibody variants are prone to aggregation or to forming product-related impurities. Explore the application of a resin with novel selectivity to purify challenging entities.

Speed To Market: API Large-Scale Commercial Manufacturing

A pharmaceutical company was looking to partner with a CMO with commercial manufacturing capabilities, large-scale assets, multinational sites, and exemplary quality systems/U.S. FDA track records.

Development, Manufacture Of Biopharmaceuticals In Microbial Systems

We discuss the trends in new molecular formats, which is one of the current drivers of renewed interest in fermentation technologies, along with some of their challenges. 

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