Newsletter | July 9, 2019

07.09.19 -- 3 Steps To Better Extractables And Leachables Studies

Five Questions On Extractables And Leachables In Clinical Development Studies

Extractable and leachable (E&L) safety assessments can be some of the most challenging review issues in an FDA application. That is because they require a coordinated effort between review staff from chemistry, manufacturing, and controls and toxicology. When should you begin your E&L studies? Do the FDA and EMA consider them differently? Learn the answers to these questions and more in this Q&A.

3 Steps To Better Extractables And Leachables Studies

There is no shortage of guidance for conducting extractables and leachables (E&L) studies. The trick is aligning standards that overlap. This summary just scratches the surface of the complexity involved in extractables and leachables studies, but it shows the value of aligning different recommendations to form a coherent strategy.

Model Extraction Studies Examined For Monoclonal Antibody In Prefilled Syringe

It’s been more than 30 years since monoclonal antibodies (mAbs) were first licensed for clinical use. But product developers are still inventing novel ways to improve their safety and efficacy.

API To Clinic In Four Months

Speed to clinic is crucial to a client's success, and a seamless package of CMC analytical development and testing, as well as manufacturing services from early phase through commercialization, can make that success possible.

Container/Closure Innovation Delivers New Complexity In Drug Quality

Many new delivery systems make dosing less cumbersome for patients and healthcare providers. But they also add more complexity for drug developers.