A basic guide to particle characterization

whitePaper | February 16, 2023

Monoclonal antibody drugs (mAbs) make up more than 50 percent of the biologics on the market today, as well as a significant number of new drugs in the development pipeline. The value and impact of these therapies has been dramatic.

whitePaper | July 1, 2023

As its title implies, Annex 1 is the European guidance document for good manufacturing practices of medicinal products. As such, it serves as the road map for sterile drug manufacturers to follow in order to arrive at the pathway to the highest level of sterility, assuring that their medicinal drug products deploy operational best practices, are certifiable, and regulatorily safe.

whitePaper | February 24, 2022

The COVID-19 pandemic and resulting economic dislocation revealed long-standing vulnerabilities in our supply chains. The pandemic’s drastic impacts on demand patterns for a range of medical products including essential medicines wreaked havoc on the U.S. healthcare system.

whitePaper | March 11, 2022

Blockchain technology is accelerating digital transformation across multiple industries, including the pharmaceutical industry.

whitePaper | May 11, 2022

CDER is taking another step towards realizing the vision for pharmaceutical quality in the 21st century: a maximally efficient, agile, flexible manufacturing sector that reliably produces high-quality drug products without extensive regulatory oversight.

whitePaper | January 20, 2023

Understanding an antibody’s mechanism of action (MOA) is critical to its clinical success. Not only does MOA have a large impact on safety and efficacy.