Future of Endotoxins and Pyrogen Testing: Reference Standards and Procedures

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Overview

The production of parenteral products requires not only that products be sterile, but that they are also free from harmful levels of pyrogens. Bacterial Endotoxins, components of the gram-negative bacterial cell wall comprise the vast majority of pyrogens found in parenteral manufacturing. For the last thirty-eight years, the predominant methods of evaluating parenteral products for the presence of bacterial endotoxins in vitro have been defined in the Bacterial Endotoxins Test <85>. This assay is analytically calibrated against the USP Endotoxin RS. The in vivo evaluation of the Pyrogenicity, however, may be measured using the in vivo Pyrogen Test employing rabbits as outlined in Pyrogen Tests<151>, USP <85>, Bacterial Endotoxins Test, although now harmonized with the Japanese Pharmacopeia and the European Pharmacopeia since 2002, has remained essentially unchanged since its introduction in USP 20-NF 15 (1980). Recently there have been reports of interferences in recovery studies, as well as the appropriate utilization of endotoxin/pyrogen calibration standards and the potential use of alternative control standards. Also, there is increased interest in non-LAL test procedures or adaptation of alternative LAL analog methods in which the reagents are recombinant rather than derived directly from animals. Additionally, the recent uptick in the use of the Rabbit Pyrogen Test has been widely debated among stakeholders.

The USP Microbiology Expert Committee has developed this workshop to enable open objective discussions of practical and science-based issues evolving in endotoxin and pyrogen testing. The purpose of this workshop is to consider new reference endotoxin standards and the requirements for the inclusion of new endotoxins test methods in the near future.

Objectives

• Engage stakeholders and provide background on USP’s effort to consider the development of a new reference standard for endotoxins and its potential applications in overcoming test interferences and depyrogenation.
• Discuss experimental design for spike recovery studies and how they can be made more representative of product manufacturing conditions.
• Examine the implementation alternate test methods for endotoxin testing
• Review current challenges and strategies for use of alternate in vitro methods and reference standards for pyrogen testing.

Why Attend?

Be a part of the discussion that will begin to address the challenges that we face as we consider the future of Endotoxin and Pyrogen Testing.

Who Should Participate

• Quality Assurance/Quality Control specialists
• Regulators & Regulatory Affairs professionals
• Research and development scientists, engineers
• Contract research organizations
• Contract manufacturing and testing organizations

Participant Resources

• <85> Bacterial Endotoxins Test
• <1085> Guidelines on Endotoxins Test
• <151> Pyrogen Test
• <1228> Depyrogenation
• <1228.5> Endotoxin Indicators for Depyrogenation

Workshop Registration Information

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Registration

Advance registration will be available through Friday, June 7 at 12:00PM (Eastern). After that time, registration will be available on-site at the USP Meetings Center.

Pricing Information

Registration is payable by credit card only. Registration fee includes the full two-day program, meeting materials, coffee breaks and lunch. Registration fees for this workshop have been set as follows:

Cancellation and Substitution Policy

Cancellation must be received on or before May 19, 2019 via email to conferences@usp.org. Refunds will not be issued for cancellations received after this date. There is a $50.00 processing fee on all cancellations; however, it is permissible to send a substitute registrant from your same organization. Substitutions must be submitted in writing via email to conferences@usp.org.

Invitation Letters for Visas

USP cannot provide an invitation letter to potential workshop attendees; however, once you are registered, USP will provide a registration confirmation that may be utilized to obtain a visa.

Registration Questions

Please contact conferences@usp.org or +1 301-816-8130.

Hotel & Travel Information

Please note that the headquarter hotel for this workshop is the Cambria Hotel and Suites Rockville. Shuttle service on Monday and Tuesday will be provided between USP and the Cambria only. The rate is $157 per night plus tax when you book using the link below by Monday, May 20th:

• https://www.choicehotels.com/reservations/groups/JH25O8

For information on additional local hotels, please click here. Please note that transportation on Monday and Tuesday will not be offered from any hotel except the Cambria.

USP Headquarters

12601 Twinbrook Parkway
Rockville, MD 20852
United States
Phone: +1-301-816-8130