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2021 Endotoxins Workshop

2021 PDA Endotoxins Workshop

Oct 07, 2021
Washington, DC

  • Workshop
  • The Americas
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Overview

On behalf of the Program Planning Committee and PDA, we would like to invite you to the 2021 PDA Endotoxins Workshop on 07 October 2021. The agenda will focus on the theme of “Practical Insights into the Evolution of Endotoxin Testing”.

Endotoxin, a cell wall component of gram negative bacteria, can cause varying levels of immune responses when introduced to the blood system. As a result, the onus is on the manufacturers of all parenteral drugs to control possible endotoxin contamination throughout the manufacturing process. As pharmaceutical manufacturing processes continue to become more streamlined and new therapy delivery continues to evolve, endotoxin control is evolving as well.

The 2021 PDA Endotoxins Workshop will provide scientific understanding and real-world practices for endotoxin testing in bio/pharmaceutical production processes.
Major topics to be covered will include:

  • Recombinant Factor C (rFC)
  • Automation
  • Data Integrity
  • The Pyrogenic Dose, Specifications and Co-infusions
  • Regulatory Compendia

We look forward to seeing you at the 2021 PDA Endotoxins Workshop in Washington, DC!

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Agenda

  • Thursday, 07 October

    09:00 – 10:30 | Plenary 1: Recombinant Factor C (rFC)
    Moderator: Anders Thorn, M.Sc. Pharm, Principal Scientist, Microbial Competence Centre, Novo Nordisk A/S

    Recombinant factor C (rFC) for endotoxin detection has been available for many years as an alternate to LAL-based testing and it has been an official method for test for endotoxin in the European Pharmacopeia since January 2021 although comparison of the performance of rFC and LAL is still subject to discussion. This session will discuss strategies for validation of the rFC method and for implementation of rFC as test for bacterial endotoxins. Furthermore, studies that evaluates the use of recombinant technology for the detection of environmental endotoxin will be summarized.
    Welcome from the Program Planning Committee Co-Chair
    rFC Implementation Strategy for Endotoxin Testing
    Thierry Bonnevay, Sanofi

    Method Validation Strategy for Endotoxin Testing of Water Samples with Recombinant Factor C
    Lindsey Silva and Evelyn Der, Genentech

    PDA Review Article: “Currently Available Recombinant Alternatives to Horseshoe Crab Blood Lysates: Are They Comparable for the Detection of Environmental Bacterial Endotoxins? A Review”
    Author

    Q&A Panel Discussion

    Break

    10:45 – 12:15 | Plenary 2: Automation/Data Integrity
    Moderator: Jessica Hankins, Associate Scientific Director, Microbiology Center of Excellence Analytical Strategy and Operations, Bristol Myers Squibb

    This session will present end user and vendor perspectives.

    CRL Endosafe Technology
    Phil Duncanson, PhD, Chief Microbiologist, Global Quality, AstraZeneca

    End User Perspective
    Mike Knight, Associate Director, QC Microbiology, Genentech

    Holy Crab! A Simple, Automated Sample-to-Answer Recombinant Factor C Assay for Bacterial Endotoxins: A Deeper Dive
    Benjamin Claywell, Eli Lilly and Company

    Q&A Panel Discussion
    • Kevin Miller, Hamilton
    • Kevin Williams, bioMerieux

    Break

    12:45 – 14:15 | Plenary 3: Current Topics in Endotoxin: The Pyrogenic Dose, Specifications and Co-infusions
    Moderator: Jay Bolden, Associate Quality Advisor-Biologist, Global Quality Laboratories, Eli Lilly and Company

    This session will focus on current hot topics.

    TPD, Rabbits/humans, 2X Safety Factor, Real Endotoxin vs. Purified, Impact of FDA-Requested 2X cut
    Karen McCullough

    What Prompted the Draft Guidance, Impacts Endotoxemia and Endotoxin Considerations in the Clinical Setting
    Speaker Invited

    Clinical Relevance of Specification/Co-infusion Impacts to Patient Safety
    Doug Roepke, MD, Medical Fellow, GPS Medical - Product Safety Assessment, Eli Lilly & Company

    Q&A Panel Discussion

    Break

    14:45 – 16:15 | Plenary 4: Regulatory Compendia
    Moderator: Ingo Spreitzer, PhD, Deputy Head, Microbiological Safety, Paul-Ehrlich-Institut (PEI)

    Hear perspectives from global pharmacopeias on the current position towards rFC, next steps and harmonization.

    EDQM
    Emmanuelle Charton, EP General Chapter 2.6.32., European Directorate for the Quality of Medicines

    Global Perspectives on rFC and MAT

    Q&A Panel Discussion

Additional Information

  • Learning Objectives

    Learning Objectives

    Upon completion of this workshop, you will be able to:
    1. Understand complex interaction of endotoxins with immune system
    2. Identify the best test method for endotoxin analysis for your company’s purpose
    3. Select appropriate endotoxin specifications for your company’s products
    4. Describe best practices for your company’s new or existing laboratories
  • Who Should Attend

    Who Should Attend

    More information coming soon.

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Travel

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.

Grand Hyatt Washington

1000 H Street NW
Washington, DC

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Grand Hyatt Washington
  • Accommodations

    Joining us in person? Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room!

    A block of rooms have been reserved for meeting participants at the Grand Hyatt Washington. The rate is $309 for single or double occupancy. Guestroom rates are subject to State and Local taxes. Reservations must be secured by Monday, September 6, 2021. After this date, reservations can be made on a space-and-rate available basis only. Check-in time is 3:00 p.m.; check-out time is 12:00 p.m.

    To make reservations, individuals may click on the reservation link above or call the Grand Hyatt Washington at +1 (202) 582-1234. Be sure to tell the reservationist that you are with the PDA Meeting to receive the PDA group rate.

    Individual Cancellation

    Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Individuals will be responsible for payment of their own cancellation fees. The cancellation policy is 3 days in advance of arrival unless otherwise specified on your reservation information.

  • Amenities

    With a pristine location in the heart of Washington D.C. neighborhood, just steps away from downtown, our hotel ensures that you're never far from where you're looking to go. Explore from Grand Hyatt Washington, conveniently connected to the WMATA Metro Center train station from our lobby, allowing you to travel the red, orange, silver, and blue lines with ease to the city's beloved destinations and neighborhoods. See all of D.C.'s top sights from our front doors.

How to Get Here

By Air

Reagan National Airport (DCA) is approximately 4.2 miles from the hotel and all major carriers service this airport. Two other airports in the vicinity are both serviced by all major carriers: Dulles International Airport (IAD), 27 miles away, and Baltimore-Washington International Airport (BWI), 32 miles away. Taxi fares from DCA are approximately $25 one way, not including tip, and will take about 15 minutes. One way taxi fares from IAD is approximately $70 and from BWI about $85.

By Car

The Grand Hyatt Washington is located at 1000 H Street NW, Washington, DC 20001. $42 (per day) Self-Parking; $62 (per day) Contactless (SMS) Valet Parking.

Other Options

The Hotel lobby is connected to the WMATA Metro Center train station. Metro fare from Reagan National Airport (DCA) is approximately $2.30 (one-way). To plan your trip please visit www.wmata.com.

Directions

Registration Fees

Early Registration
Registration Type Price by 31 August 2021
Member $598
Non-member $738
Govern./Health Authority/Academic Member $280
Govern./Health Authority/Academic Non-member $320
Student Member $112
Student Non-member $124
Early Career Professional
Member		 $299
Regular Registration
Registration Type Regular Registration
 Price after 30 September 2021
Member $837 $1,076
Non-member $1,033 $1,328
Govern./Health Authority/Academic Member $392 $504
Govern./Health Authority/Academic Non-member $448 $576
Student Member $157 $202
Student Non-member $174 $223
Early Career Professional
Member		 $419 $538

* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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