11.13.21 -- The Challenges Of Moving A Bioconjugate Candidate From Clinic To Market

There are three major challenges inherent to commercializing a biotherapeutic: technical challenges, regulatory challenges, and market supply challenges. Working with a partner that can provide a one-stop shop for bioconjugate development and manufacturing can help prevent any missteps that could threaten a biopharmaceutical company’s ability to deliver life-saving drugs to patients who need them.

Lonza Biologics recently presented a webinar on the design of dissolution media to support biopredictive dissolution testing, which enables the development of bioavailability-enhancing formulations for poorly soluble drugs.

Size exclusion chromatography (SEC), also known as gel filtration, is the mildest of all chromatography techniques. SEC separates molecules by their differences in size as they pass through a resin packed in a column. You can use SEC for both preparative and analytical studies of your protein. But how do you know which parameters will give you the best resolution of your protein mixture?

A research-based biopharmaceutical company had recently transitioned from paper-based experimental documentation towards increasingly electronic-based systems. Through the integration of their lab informatics systems the customer has observed improvements in both compliance and workflow efficiency.

The number of regulatory submissions in China is increasing. This webinar provides an overview of Chinese regulations with a specific focus on data and requirements for clinical trial applications.