Submitted by LER moderator, Karen McCullough
Before and Beyond LER is the theme of this year’s Bacterial Endotoxin Summit sponsored by the PMF. It is the ORIGINAL summit on endotoxin testing and the 11th annual summit.
In spite of the recent focus on LER, the rest of the LAL world marches on, and we are still challenged by some new concepts as well as some old ones. We are excited to expand this year’s BES offering to include discussions on some common laboratory concerns including experiences on the validation of the Monocyte Activation Test (MAT), considerations for testing of unique new cell, gene and combination products, the importance of laboratory disposables, and investigation of endotoxin OOS results, including a discussion of the rabbit Pyrogen test.
Because of the ongoing focus on LER in our industry, we will also include two talks focused on the issue. One is to help us understand what’s happening on a molecular level with LER and the other is to look at conclusions drawn from a BPOG study that used a common protocol to assess LER variability across companies.
I’ve provided a list of speakers who have committed to date and their presentation titles, and encourage you to explore the BES website for further information. I hope to see you in Dallas on February 6-7!
Jay Bolden (Lilly) will present “Results of a Harmonized Endotoxin Recovery Study Protocol Evaluation by 14 BioPhorum Operations Group (BPOG) Member Companies” This study is an important multi-laboratory study on LER using a common protocol to collect comparable data.
Allen Burgenson (LONZA) will present Challenges in testing cellular/gene therapy products and combination products which speaks to testing considerations such as calculation of endotoxin limits and test sample preparation for these unique products.
James F. Cooper, Pharm D (endotoxin consultant) will present Pyrogenic Outbreaks: 1970 to Present;OOS Investigations. This presentation will take us through OOS investigations and in the process will bring in a discussion of the rabbit Pyrogen test. Many of us have forgotten about the rabbit test, but the LER discussion has brought it back into the spotlight.
Masakazu Tsuchiya, Ph. D, (Charles River) will present “Case Studies: Invisible Interference in Bacterial Endotoxins Test “, which will help us to understand the mechanism of LER interference
Ned Mozier, PhD (Pfizer) will present “Progress and Pitfalls of the Monocyte Activation Test as Relates to Product Quality Assessment”, which speak to his experience in the validation of the Monocyte Activation Test (MAT), an alternate test to the compendial Bacterial Endotoxins Test
Veronika Wills (Associates of Cape Cod) willpresent The Importance of Using Qualified Disposables for the LAL Based Assays, which will remind us of the importance of laboratory disposables and how they can affect your BET test results.
A representative from USP will speak to the characterization and possible uses of their proposed native Control Standard Endotoxin.
Early Bird Registration ends this Thursday, December 15th. Register now to save $200! Click here to read more and register.