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2018 PDA Endotoxins Workshop

Oct 17 - Oct 18, 2018
Bethesda, MD

The Future of Endotoxins Testing: Guidance, Compliance, and Quality

  • Workshop
  • Western Hemisphere Events

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Program Highlights

Whether you're a microbiologist, manufacturing scientist, or work in the quality department, you'll gain valuable insight and learn practical approaches to help you better manage and control endotoxin contamination. Hear the latest in real-world practices for endotoxin testing in bio/pharmaceutical production processes during this Workshop which follows the 13th Annual PDA Global Conference on Pharmaceutical Microbiology

Overview

Endotoxin control of pharmaceutical API and biopharmaceutical drug substances or API production processes is a significant quality and compliance problem today.

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 2018 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:

  • Academic Perspectives on Immune Response to endotoxins
  • Low Endotoxin Recovery (LER)
  • Data Integrity
  • Beta-Glucans: Practical Issues Associated with Pharmaceutical Manufacturing
  • Non-LAL based endotoxin detection methods
  • BET Laboratories: Practical Advice

This Workshop will present practical approaches to endotoxin testing that participants can use in daily work and laboratory operations.

Learning Objectives

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

  • Understand complex interaction of endotoxins with immune system.
  • Describe best practices for your company’s approach to address LER
  • Identify the best test method for endotoxin analysis for your company’s purpose
  • Recognize possible inhibitors and enhancers of the LAL test
  • Select appropriate endotoxin specifications for your company’s products
  • Describe best practices for your company’s new or existing laboratories

Who Should Attend

Department 
Biochemistry | Biology | Manufacturing | Microbiology | Development | Quality | Regulatory Affairs | Research | Technical Operations | Validation

Job Function 
Biologist | Microbiologist | Operator/Technician | Pharmacist | Product Manager | Scientist/Researcher

Conference Inquiries

Annette Bacchus
Manager, Programs
Tel: +1 (301) 656-5900 ext. 221
Email: bacchus@pda.org

Registration Inquiries

Tel: +1 (301) 656-5900 ext. 115 
Email: registration@pda.org

Exhibition/Sponsorship Inquiries

David Hall
Vice President, Sales
Tel: +1 (301) 656-5900 ext. 160 
Email: hall@pda.org

Agenda

  • Wednesday, October 17

    11:30 a.m. – 5:45 p.m.
    Registration Open

    1:45 p.m. – 2:00 p.m.
    Welcome and Opening Remarks fro Co-Chair
    Ned Mozier, PhD, 
    Senior Director, Pfizer, Inc.

    2:00 p.m. – 3:30 p.m.
    P1: rFC and its Application
    Moderator: Ned Mozier, PhD, Senior Director, Pfizer Inc.

    The use of recombinant factor C (rFC) for endotoxin detection has been available for many years as an alternate to LAL-based testing.  However, rFC has not gained a proportional use to date, although new trends suggest this might be changing. There are at least two sources of rFC available, and recent publications that suggest it performs similarly on actual biotech samples to LAL. In some cases, there are advantages afforded rFC. The purpose of this section is to review the background regarding the rFC invention and the data from industry comparing it to LAL, as well as the overall burden of changeover. Other factors, such as sustainability of using a natural animal source for LAL will be discussed, as well as future thinking about where our industry might be headed.

    2:00 p.m. – 2:30 p.m.
    rFC – From Genetic Engineering to Biomedical/Industrial Applications in Endotoxin Detection
    Lynne JL Ding, PhD,
    Professor, National University of Singapore

    2:30 p.m. – 3:00 p.m.
    rFC – The Road Less Traveled:  An Implementation Update and Shared Learning
    Jay Bolden, Senior Consultant Quality-Biologist, Eli Lilly and Company

    3:00 p.m. – 3:30 p.m.
    Questions and Answers/Discussion

    3:15 p.m. – 7:00 p.m. 
    Exhibit Area Open

    3:30 p.m. – 4:00 p.m.
    Refreshment Break and Poster Presentations in Exhibit Area

    POSTER PRESENTATIONS
    The following posters will be presented during all refreshment breaks on Wednesday and Thursday

    1. Faster, Further - Reliably & Sustainably. A New Product Offering for Recombinant Factor C Endotoxin Testing
    Gregory Devulder, PhD,
     Endotixin Program Director, bioMérieux

    2. The Automation of Endotoxin Testing: Streamlining Your QC Testing with Automated Endotoxin Testing and Process Optimization
    Robert Porzio, Product Manager, Lonza Walkersville Inc.

    3. An Organized Data Driven Approach to Endotoxin Investigations
    Matthew Paquette, Product Specialist - Technical Specialist, Charles River Laboratories, Inc.

    4. Which LAL Photometric Assay Is the Best Fit for Your Sample?
    Ann Workman, MSc, Senior Technical Services Representative, Associates of Cape Cod, Inc.

    4:00 p.m. – 5:30 p.m.
    P2: Monocyte Activation Test (MAT): Considerations for Implementation in the Pharmaceutical Industry
    Moderator: Friedrich von Wintzingerode, PhD, Senior Manager Global Analytical Science & Technology Microbiology, Roche-Genentech

    When present in parenteral products, microbial pyrogenic substances (also referred to as Pathogen Associated Molecular Pattern” [PAMP]) can cause life threatening fevers. The human response to PAMPs is regulated by monocytes. The activation starts with PAMP binding to toll-like receptors (e.g. TLR2, TLR4, TLR7, TLR8, TLR9) and involves a cascade of intracellular reactions resulting in a release of pro-inflammatory cytokines. The traditional methods for pyrogen detection either require animal use for the Rabbit Pyrogen Test (RPT), or are limited to the detection of endotoxin (LAL). This session will describe considerations for implementation of the MAT in the pharmaceutical industry.

    4:00 p.m. – 4:30 p.m.
    MAT: The Stony Way to the Stars
    Peter Bruegger,
    Head Bioassay & Microbiology, Lonza AG

    4:30 p.m. – 5:00 p.m.
    MAT: How to Conduct a Risk Analysis and Develop a Test Protocol
    Ned Mozier, PhD,
    Senior Director, Analytical R&D, Pfizer Inc.

    5:00 p.m. – 5:30 p.m.
    Questions and Answers/Discussion

    5:30 p.m. – 6:30 p.m.
    Networking Reception in Exhibit Area

    Thursday, October 18, 2018

    7:30 a.m. – 5:45 p.m.
    Registration Open

    7:30 a.m. – 8:30 a.m.
    Continental Breakfast

    8:30 a.m. – 10:00 a.m.
    P3: Depyrogenation
    Moderator: Jay Bolden, Senior Consultant Quality-Biologist, Global Quality Laboratories, Eli Lilly and Company

    Endotoxin removal by depyrogenation is key to successful parenteral manufacturing. In recent years, USP has dedicated 4 chapters to depyrogenation. This session will discuss general depyrogenation, dry heat depyrogenation, depyrogenation by filtration and endotoxin indicators. A formal risk analysis will be done for the removal of endotoxin in a basic parental process.

    8:30 a.m. – 8:50 a.m.
    Industry Perspective on Depyrogenation
    IJames E Akers, PhD,
     President, Akers Kennedy & Associates

    8:50 a.m. – 9:10 a.m.
    Depyrogenation of Primary Packaging - Pharmaceutical Washing Process Validations.
    Antje Hermelink,
     Sr Manager Laboratory GER, Global SME, West Pharmaceutical Services

    9:10 a.m. – 9:30 a.m.
    Case Study: Dry-Heat Depyrogenation of Glass Articles
    Veronika S. Wills,
    Associate Manager, Technical Services, Associates of Cape Cod, Inc.

    9:30 a.m. – 10:00 a.m.
    Questions and Answers/Discussion

    9:45 a.m. – 5:15 p.m.
    Exhibit Area Open

    10:00 a.m. – 10:30 a.m.
    Refreshment Break and Poster Presentations in Exhibit Area

    10:30 a.m. – 12:00 p.m.
    P4: Endotoxins and Other Immune Modulating Impurities
    Moderator: Johannes Reich, PhD, GM Endotoxins, Microcoat Biotechnologie GmbH

    There are many factors that can stimulate the innate immune systems. Historically, analytical testing has focused on fever and the responses of the innate immune system, which are immediate and measurable responses. However, with the advent of biologics, the adaptive immune system responses have become more and more important. The innate immune system has been found to trigger adaptive immune responses. The growing knowledge of the interface between innate and adaptive immunity needs to be explored to adjust current microbial control concepts. Microbial impurities of parenterals can induce significant immune responses and negative effects on patient safety. In contrast, for vaccines, the presence of “microbial impurities” also may have beneficial effects. Adding defined amounts of stimulating components, such as “detoxified” LPS to the product has shown to improve efficacy. The mechanisms behind this practice are still not fully understood and further research is needed. In this session, innate immune response-modulating impurities are explained and strategies for their control are discussed.

    10:30 a.m. – 11:00 a.m.
    In Vitro Tools to Control Product Quality Attributes Related Risk Assessments for Ocular Biologic Drugs
    Quin (Joe) Zhou, PhD, 
    Associate Director, Allergan

    11:00 a.m. – 11:30 a.m.
    Endotoxin in the Adaptive Immune Response
    Kevin Willliams,
    Senior Scientist, bioMérieux

    11:30 a.m. – 12:00 p.m.
    Questions and Answers/Discussion

    12:00 p.m. – 1:30 p.m.
    Lunch on Your Own. Exhibit Area Closed. A listing of local restaurants is available at the PDA registration desk.

    1:30 p.m. – 3:00 p.m.
    Bacterial Endotoxin Testing and Data Integrity

    • Session 1: 1:30 p.m. – 2:00 p.m.
    • Session 2: 2:00 p.m. – 2:30 p.m.
    • Session 3: 2:30 p.m. – 3:00 p.m.

    Attendees will participate in all breakouts, for 30-minutes each.

    Data integrity continues to be an area of concern among industry and regulatory agencies. The five ALCOA principles encompass all quality data, including data generated using bacterial endotoxin test. In these breakout sessions, data integrity case studies and risk assessments using gel clot, kinetic, and automated endotoxin testing platforms will be presented. Additionally, attendees will participate in small group discussions to better understand data integrity and bacterial endotoxin testing.

    Group A – Gel Clot Endotoxin Testing

    Moderator: Friedrich von Wintzingerode, PhD, Senior Manager Global Analytical Science & Technology Microbiology, Roche-Genentech

    Risk Assessment of LAL Test Using Gel-Clot Technique Requiring Contemporaneous Verification
    Youwen Pan, PhD,
    Sr. Scientist, Genentech

    Group B – Kinetic Testing

    Moderator: Jessica V. Hankins, PhD, Microbiologist, CDER, FDA

    Designing Systems for Data Integrity
    James Henderson,
    Consultant QA, Eli Lilly and Copmany

    Group C – Automated Testing

    Moderator: Jay Bolden, Senior Consultant Quality-Biologist, Global Quality Laboratories, Eli Lilly and Company

    Data Integrity Assessment of the Charles River Endosafe Nexus Testing System
    Scott Kaszuba,
    QC Manager, Pfizer Inc. (Invited)

    3:00 p.m. – 3:30 p.m.
    Refreshment Break in Exhibit Area

    3:30 p.m. – 4:45 p.m.
    P5: Current LER Perspectives: Part 1
    Moderator: Josh Eaton, Senior Project Manager, Scientific & Regulatory Affairs, Parenteral Drug Association

    Members of PDA’s LER Task Force will present an overview of the three main topics from the LER technical report: 1) the underlying mechanisms and contributing factors of LER, 2) the potential clinical impact of the LER phenomenon, and 3) guidelines for developing LER hold-time study design and LER mitigation strategies. Following the technical report overview will be a discussion of a practical example of addressing LER in existing commercial products.

    3:30 p.m. – 3:45 p.m.
    LER Technical Report Overview
    Friedrich von Wintzingerode, PhD, Senior Manager Global Analytical Science & Technology Microbiology, Roche-Genentech

    3:45 p.m. – 4:05 p.m.
    Proposed Mechanism for LER
    Jack Levin, MD, Professor of Laboratory Medicine and Medicine, University of California School of Medicine, San Francisco

    4:05 p.m. – 4:15 p.m.
    Q&A with Jack Levin, MD

    4:15 p.m. – 4:35 p.m.
    Potential Safety Impact of LER and LER Mitigation Strategies
    Ned Mozier, PhD, Senior Director, Analytical R&D, Pfizer Inc.

    4:35 p.m. – 4:45 p.m.
    Q&A with Ned Mozier, PhD

    4:45 p.m. – 5:00 p.m.
    Break

    5:00 p.m. – 6:00 p.m.
    P5: Current LER Perspectives: Part 2
    Moderator: Josh Eaton, Senior Project Manager, Scientific & Regulatory Affairs, Parenteral Drug Association

    Members of PDA’s LER Task Force will present an overview of the three main topics from the LER technical report: 1) the underlying mechanisms and contributing factors of LER, 2) the potential clinical impact of the LER phenomenon, and 3) guidelines for developing LER hold-time study design and LER mitigation strategies. Following the technical report overview will be a discussion of a practical example of addressing LER in existing commercial products.

    5:00 p.m. – 5:20 p.m.
    Industry Perspective on LER
    Anders Thorn, Principal Scientist, Microbiologist, Novo Nordisk A/S

    5:20 p.m. – 5:30 p.m.
    Q&A with Anders Thorn

    5:30 p.m. – 5:50 p.m.
    Case Study: Low Endotoxin Recovery for Existing Commercial Products
    Mark J. Kapeckas, Biologics Corporate Quality Program Manager, Sanofi Biologics

    5:50 p.m. – 6:00 p.m.
    Q&A with Mark J. Kapeckas

    6:00 p.m.
    Closing Remarks from Workshop Chair
    Friedrich von Wintzingerode, PhD, Senior Manager Global Analytical Science & Technology Microbiology, Roche-Genentech



Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.

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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.

Bethesda North Marriott Hotel & Conference Center

5701 Marinelli Rd
Bethesda, MD

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Registration Fees

Regular Price

Conference and Workshop Registration | October 15-18

Member

By August 4, 2018
$3,340

After August 4, 2018
$4,240

Non-member

By August 4, 2018
$3,819

After August 4, 2018
$4,719


Workshop Registration | October 17-18

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By August 4, 2018
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After August 4, 2018
$1,695

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By August 4, 2018
$1,695

After August 4, 2018
$1,895


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$700

After August 4, 2018
$700

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By August 4, 2018
$800

After August 4, 2018
$800


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$700

After August 4, 2018
$700

Non-member*

By August 4, 2018
$800

After August 4, 2018
$800


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By August 4, 2018
$280

After August 4, 2018
$280

Non-member*

By August 4, 2018
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After August 4, 2018
$310


Young Professional Member †

Member

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$998

After August 4, 2018
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All prices in US dollars.

* For this member type or discounted rate, online registration is not available and must be faxed in.

† You must be a member to take advantage of this rate.

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Please read PDA's confirmation, substitution, refund, and photo release policies for this workshop and course.

Group Registration Discount

Register 3 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 4th registration free. Other discounts cannot be applied.

Special Dietary Requirements

Please let us know if you have any special dietary requirement we may assist you with. Please contact us at registration@pda.org for help.

CONFIRMATION: A letter of confirmation will be sent to you once payment is received. You must have this written confirmation to be considered enrolled in a PDA event. Please allow one week for receipt of confirmation letter. If you have submitted a purchase order or requested an invoice please be advised that a credit card guarantee is needed. Please be advised that if your payment or written cancelation notice is not received byAugust 16, 2018 your credit card will be charged the prevailing rate.

SUBSTITUTIONS: If you are unable to attend, substitutions can be made at any time, including onsite for a fee of $200. If you are a non-member substituting for a member, you will be required to pay the difference non-member fee. If you are pre-registering as a substitute attendee, indicate this on the registration form.

REFUNDS: Refund requests must be in writing and faxed to +1 (301) 986-1093. (Emails and phone messages are not accepted). Refunds for Full Conference, Workshops and Events: If your written request in received on or before August 16, 2018, you will receive a full refund minus a $200 processing fee. After that time, no refunds or credit requests will be approved. Onsite registrants are not guaranteed to receive Conference materials until all advanced registered attendees receive them. PDA reserves the right to modify the material or speakers/instructors without notice or to cancel an event. If an event must be canceled, registrants will be notified by PDA in writing as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancelation. For more details, contact PDA at info@pda.org or +1 (301) 656-5900.

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* For this member type or discounted rate, online registration is not available and must be faxed in.

† You must be a member to receive this rate.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Group Registration Discount

Register 3 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 4th registration free. Other discounts cannot be applied.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

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 as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact registration@pda.org or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to registration@pda.org. Phone messages are not accepted.

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