Monitoring and control of endotoxin are critical aspects of an overall microbial control strategy necessary to ensure drug product quality and patient safety. It has been over a decade since Low Endotoxin Recovery (LER) came into prominence as a major challenge in biologics manufacturing, due to the common use of formulation excipients such as polysorbate, phosphates, etc. that have been shown to interfere with the compendial endotoxin detection methods. Since then, industry and regulators have made gains in understanding LER and developing standardized approaches for evaluating and overcoming it. However, there still is much progress to be made. Developing alternative methods that address LER is sometimes a labor intensive task and may result in complicated methods that lack robustness or are difficult to implement, in some occasions leaving Sponsors with the Rabbit Pyrogen Test as the “only option” for endotoxin detection. This is further complicated as some health authorities and industry take steps towards removing animal testing. The purpose of this session is to provide an overview of endotoxin methods and microbial controls to mitigate LER and discuss evolving regulatory expectations, challenges, and potential solutions.

Session Speakers:

Overcoming Low Endotoxin Recovery from Theory to Practice

Jessica Hankins, Bristol-Myers Squibb Company

Defining the Microbial Control Strategy for Low Endotoxin Recovery Impacted Biologics

Lindsey Silva, Genentech, a Member of the Roche Group

Additional Panelists:

Jay Bolden, Eli Lilly and Company

Claudia Müller, Swissmedic

Jody Peraino, Pfizer, Inc.

Arne Staby

Appearances