2018 PMF Bacterial Endotoxin Summit - Investigating BET Out of Specification (OOS) Results 

The 2018 Bacterial Endotoxin Summit (BES) is the 12th annual meeting in a series devoted to the dissemination of non-commercial, scientific information on various topics of interest to scientists interested in the Bacterial Endotoxins Test. 

Join this hands-on workshop to unearth clues and execute an endotoxin failure (OOS) investigation for a virtual biologic combination product.  A faculty of top endotoxin testing experts will work with participants to understand the following topics for determining the root cause:

• Case study: Example of a real life LAL failure investigation
• Organizational strategies for investigation OOS
• Calculating endotoxin limits and testing strategies for medical devices and c combination drugs
• Depyrogenation of product contact components
• Where does Endotoxin come from?
• Points to consider for BET testing of biological product formulations
• Monocyte Activation Testing - how does this fit in?
• Controlling your laboratory

 

Moderator/Speaker: Karen McCullough 

Karen Zink McCullough is principal consultant at MMI Associates, a consulting firm specializing in Endotoxin and Microbiology Testing, GMP Auditing and Compliance, Laboratory Auditing and Compliance and Quality Assurance including nonconformance investigation and CAPA.  Ms McCullough has over 35 years of experience in the Pharmaceutical Industry, and has worked in aseptic manufacturing, oral dosage, and diagnostics sectors. She is a highly respected speaker and trainer both nationally and globally.  Karen's current interests are the use of microbiological assays as tools for process control.

 Ms. McCullough is a charter member and current Chair of the LAL Users' Group.  She is an elected member of the Microbiology General Chapters Expert Committee of the United States Pharmacopeia and serves as a member of the United States delegation to TC2-9, WG02, revision to ISO 14698 (Biocontamination standard).  She recently edited the book, "The Bacterial Endotoxins Test:  A Practical Guide", which provides background and advice on a range of topics related to the compliant performance of the Bacterial Endotoxins Test.

 

Speaker: Allen Burgenson, LONZA

Allen L. Burgenson is the Regulatory Affairs Manager for Lonza Walkersville, Inc. and has over 30 years of experience in industries regulated by the FDA, including Foods, Drugs, Biologics, Medical Devices, and Cosmetics. He has worked in R&D, QC, QA and Regulatory Affairs.

Allen is the President of the Capital Area Chapter of the Parenteral Drug Association (PDA), and is involved in PDA activities on the local, national, and international level.  He has been a Program Committee member for the annual PDA/FDA Joint Regulatory Conference in Washington, DC, and served as the Chair for this meeting in 2004. He is a member of the Horseshoe Crab Advisory Panel for the Atlantic States Marine Fisheries Commission (ASMFC).

 

Speaker:  Jim Cooper

James F Cooper, PharmD, was Professor of Pharmacy at the Medical University of South Carolina before founding Endosafe in 1987.   This year he received the James P. Agalloco Award for teaching excellence at PDA.  His thesis work under Dr. Jack Levin at The Johns Hopkins University in 1971 led to application of the bacterial endotoxin test (BET) for parenteral products. His publications span the history of LAL technology.  Since retirement in 2001, he continues his consultation, teaching, publishing related to endotoxin issues, BET root-cause investigations and CGMPs for positron-emission tomography drugs.

 

 

Speaker:  John Dubczak 

John Dubczak is the General Manager for the Endotoxin and Microbial Detection division of Charles River Laboratories.  Prior to joining Endosafe® , he was a long term employee of Baxter Healthcare Corp.  While in the R&D Lab, he developed Baxter’s proprietary LAL formulation and manufacturing process.  He also developed methods for product testing and explored the clinical applications of LAL.  His 7 years of Large Volume Parenteral manufacturing experience provides a complete perspective to LAL testing in the pharmaceutical industry.

 

 

Speaker: Veronika Wills 

Veronika Wills serves as the Associate Manager, Technical Services at Associates of Cape Cod, Inc.  Her interests include biochemistry, microbiology and immunology, and she holds a Master’s Degree in Biochemical Engineering.  Veronika has been with Technical Services at Associates of Cape Cod, Inc., for nearly 10 years and has been conducting BET training workshops, seminars and webinars in the U.S. and abroad.

 

Speaker: Tammy Thurman

Tammy Thurman is a Scientist in Pfizer’s Analytical Research and Development organization within the division of Biotherapeutics Pharmaceutical Sciences.  She developments, optimizes and qualifies bioassays, supports in-process endotoxin testing and performs all low endotoxin recovery studies.  She has a considerable amount of cell based functional assay experience and has worked for the past several years supporting Pfizer’s Biosimilar Projects.  Pfizer has a diverse portfolio including monoclonal antibodies, conjugates, therapeutic proteins and vaccines.  Tammy was previously an employee of Pharmacia, Monsanto and Searle.  She received her B.S. in the Teaching of Biology from the University of Illinois (Champaign, IL U.S.).

Speaker:   Radha Tirumalai

Dr. Radhakrishna Tirumalai is a Senior Scientist in the USP,

 Division of Documentary Standards. He is the Staff Liaison to the USP Expert Committees on microbiology and sterility assurance, and generaltoxicology and medical device biocompatibility. He works with the industry/ academia/ government and the USP Expert Committeen the development and revision of general chapters and monographs in these areas. He has been with the USP since 2003. Prior industry experience encompasses process and product research &development, process and product transfer and product manufacturing. He holds a PhD degree in biochemistry. His postdoctoral work included studies on HIV and MuLV reverse transcriptases and bacteriophage lambda integrase. He has authored several publications, and, has been a speaker at many national and international scientific meetings.

Speaker:   Kevin Williams 

Kevin studied microbiology at the Texas A&M University and has worked in the pharmaceutical field for 35 years. The bulk of his career was spent at Eli Lilly & Company (30 years) developing QC tests for microbial and endotoxin detection. Kevin‘s current role at bioMérieux as Senior Scientist focuses on endotoxin test method development, and he has also helped setting up a dedicated endotoxin service laboratory in the USA. He is the author of: Endotoxins 2nd Edition (Marcel Dekker, 2001) and Endotoxins 3rd Edition (Informa Healthcare, 2007).

Schedule of Events

TRAVEL INFORMATION

Nearest Airport:  PHL

Location of conference:

DoubleTree by Hilton Hotel - Philadelphia Center City

237 S. Broad Street

Philadelphia, PA   19107 

Register Now! 

Cancellation Policy: PMF and Microbiology Network reserve the right to modify or cancel any event.  In the event of a cancellation, registrants will be notified as soon as possible and all registration fees will be reimbursed.  PMF and Microbiology Network are not responsibile for lost airfare due to cancellations.  Refund requests received at least 14 days prior to the date of the event will receive a full refund, less a $200 processing fee.  After that, no refunds will be issued.You may enroll a substitute at any time before the conference begins.