Endotoxin Attributes, Detection, Clinical Relevance and BET – Interference Resolution – New Course

Arlington, VA
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Duration:  1 day
Time: 8:30 a.m. - 4:00 p.m.

This course discusses all aspects of the biological attributes, control, detection and risk management of bacterial endotoxin. Pharmacopeial methods and regulatory guides are discussed in detail with respect to microbiological control of endotoxin, design and validation of depyrogenation studies, creation of procedures for a robust bacterial endotoxin test (BET), and selection of BET methods, instrumentation and software. Management functions include preparation of the endotoxin sections of applications for new drugs or devices, and readiness for audits and inspections.

Agents and conditions that cause interference with the BET are detailed. Discussions include insight into the controversy regarding the role of lipopolysaccharide (LPS) and native endotoxin when conducting BET inhibition studies for in-process and finished parenterals. Experimental design for LPS and NOE recovery studies must address choice and activity of the analytes, incubation periods and BET methods. Case studies provide practical ways to overcoming BET interference conditions.

Participants are given practical examples for design of BET suitability studies, for calculation of alert and action limits for various drugs and devices, and for training and management of an efficient BET operation. The advantages of centralized laboratory versus sample point-of-use in a manufacturing environment are reviewed.

Who Should Attend

Those who work in biologics, small molecule, or vaccine manufacturing for testing, interpreting data, performing risk mitigations, or are involved in regulatory submissions for endotoxin measurement and investigations will benefit from this course.

  • Quality Control/Quality Assurance - Technicians, Microbiologists, Managers and Supervisors
  • Depyrogenation/Validation - Technicians, Specialists, Managers and Supervisors
  • Water Systems - Specialists, Managers and Supervisors
Event Location
Hyatt Regency Crystal City at Reagan National Airport
2799 Jefferson David Hwy, Arlington, VA Get Directions

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More information coming soon.

Day 1

Upon completion of this course, you will be able to:

  • Describe the chemical and physical characteristics of bacterial endotoxin
  • Recognize the clinical relevant of endotoxin levels
  • Identify the clinical symptoms of a pyrogenic reaction
  • Discuss the principal sources of endotoxin contamination in a manufacturing setting
  • Conduct a validation study for depyrogenation by dry-heat, washing or chemical methods
  • Organize and direct a cGMP laboratory for robust bacterial endotoxin testing (BET)
  • Write regulatory compliant procedures for endotoxin measurement
  • Develop selection criteria for endotoxin detection methods and instrumentation/software
  • Calculate product-specific endotoxin limits and set alert and action levels
  • Conduct an endotoxin recovery study to distinguish low lipopolysaccharide or endotoxin recovery from other sources of BET inhibition
  • Discuss sample preparation techniques for overcoming BET-test interference conditions
  • Design a study to validate BET suitability tests for in-process and finished products
  • Develop training and risk assessment programs for endotoxin control
  • Investigate an endotoxin excursion and identify root causes
  • Prepare endotoxin sections of regulatory submissions for new drug or device applications
Agenda is subject to change.

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Hyatt Regency Crystal City at Reagan National Airport

2799 Jefferson David Hwy
Arlington, VA ,
James F. Cooper, Endotoxin Consultant

Beginning in 1970, Dr. Cooper pioneered development of the LAL test as a sensitive detector of endotoxin (pyrogen) in parenteral products. His publications span the history of LAL technology. In 1987, he founded Endosafe Inc., a producer of LAL reagent. He consults on endotoxin issues and is a retired Professor of Pharmaceutical Sciences at the Medical University of South Carolina College of Pharmacy, Charleston. He holds a Doctor of Pharmacy and a Bachelor of Sciences in Pharmacy from the University of Tennessee and a Master of Science from The Johns Hopkins University. He has held many offices in the American Pharmacy Association, Society of Nuclear Medicine, and Parenteral Drug Association, including the PDA Board of Directors (1983-85). He was presented the PDA's James P. Agalloco Award for Excellence in Education in 2013. He served on the USP Council of Experts for Sterile Compounding (2005-2010) for Chapter <797>.

Cheryl Platco, Principal Scientist, Analytical Sciences, Merck Research Laboratories

Ms. Platco has been involved with endotoxin testing for 28 years. She has experience with all three of the major U.S. LAL vendors (ENDOSAFE, LONZA and ACC.) She performs testing for pharmaceutical, vaccine, biological, and monoclonal products as well as a variety of raw materials, active ingredients, and culture media. Ms. Platco is involved with the PDA and BPOG Low Endotoxin Recovery task forces and has published numerous articles on the subject.