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2018 PDA Endotoxins Workshop

The Future of Endotoxins Testing: Guidance, Compliance, and Quality
Oct 17 - Oct 18, 2018 |
Oct 18, 2018 |
Bethesda North Marriott Hotel & Conference Center | Bethesda, MD
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  • Western Hemisphere Events
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Speaker Biographies

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

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

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
Industry Representative Invited

8:50 a.m. – 9:10 a.m.
Industry Perspective on Depyrogenation
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.
Industry Perspective on Endotoxins and Other Modulating Impurities
Industry Representative Invited

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
Industry Representative Invited

5:20 p.m. – 5:30 p.m.
Q&A with Jennifer Farrington, PhD

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



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

Member

By August 4, 2018
$1,495

After August 4, 2018
$1,695

Non-member

By August 4, 2018
$1,695

After August 4, 2018
$1,895


Government/Health Authority

Member

By August 4, 2018
$700

After August 4, 2018
$700

Non-member*

By August 4, 2018
$800

After August 4, 2018
$800


Academic

Member

By August 4, 2018
$700

After August 4, 2018
$700

Non-member*

By August 4, 2018
$800

After August 4, 2018
$800


Student

Member

By August 4, 2018
$280

After August 4, 2018
$280

Non-member*

By August 4, 2018
$310

After August 4, 2018
$310


Young Professional Member †

Member

By August 4, 2018
$998

After August 4, 2018
$1,298

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.

Please note: In order to receive the prevailing registration rate, your registration(s) must be received by PDA by 5:00 p.m. ET on or before the date noted.

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.

PLEASE NOTE: Photo ID will be required in order to pick up badge materials on-site. This important security procedure will prevent anyone other than the registrant from picking up their badge and materials.

RECORDING/PHOTO RELEASE: By registering for these events, I authorize PDA to record and photograph me and to use the recordings/photographs in all formats and media for any purpose, including for education, marketing and trade purposes. I hereby release PDA from all claims arising out of the use of the recordings/photographs, including without limitation all claims for compensation, libel, invasion of privacy or violation of copyright ownership. Tape recordings are prohibited at all PDA Conferences.

Bethesda North Marriott HotelBethesda North Marriott Hotel & Conference Center
5701 Marinelli Rd
North Bethesda, MD 20852
Phone: +1 (301) 822-9200

Rate: Single: $269.00, plus applicable state and local taxes.

Cut Off Date: Monday, September 17, 2018 (Rooms must be secured by this date in order to receive the PDA rate). Rates are guaranteed until the PDA block of rooms are sold out on a first come basis.

Hotel Accommodations

To make reservations at the Marriott Bethesda North Hotel and Conference Center, please call the Hotel at +1 (301) 822-9200 and reference the PDA Meeting to receive the PDA group rate. Check in time is 4:00 p.m. and check out time is 12:00 p.m.

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 6:00 p.m. on the date of arrival otherwise specified on your reservation information.

Amenities

The Marriott Bethesda North Hotel & Conference Center is adjacent to the White Flint METRO Station on the RED line offering easy access to Rockville, Bethesda, Washington D.C. and Northern Virginia. All 220 guest rooms and suites provide high-speed Internet, upgraded Marriott Revive bedding, coffee makers, hair dryers, iron, and an ironing board. This hotel has a smoke-free policy and no pets are allowed.

Travel

Area Airports
Reagan National Airport (DCA) is approximately 20 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, 24 miles away, and Baltimore-Washington International, 34 miles away.

Ground Transportation
Taxi fares from DCA are approximately $55 one way, not including tip, and will take about 30 minutes. One way taxi fares from Dulles is approximately $55 and from BWI about $75.

Driving
Bethesda North Marriott is located on Marinelli Road off of Rockville Pike in Rockville.

Metro
The Bethesda North Marriott is located on the RED line at the White Flint Station.

Hotel Parking
$15 Self Parking


Sponsorship and Exhibit Opportunities are Available!

The 2018 PDA Endotoxins Workshop offers exciting and unique sponsorship and exhibition packages designed to strengthen brand image, increase visibility, and help you connect with industry leaders. Attendees will include industry professionals from manufacturing, microbiology, development, biology, quality, regulatory affairs, technical operations, validation, and biochemistry.

At this conference you will be exposed to high quality attendees from a variety of manufacturing companies – making this a must attend meeting. In addition, high profile sponsorships are available for lanyards, notepads, audience response systems, tote bags, pens, refreshment breaks, lunch and networking reception. We’ll create a customized sponsorship to fit your needs and budget.

For more information about exhibit and sponsorship opportunities, please contact:

David Hall, Vice President, Sales

Tel: +1 (301) 760-7373
Cell: +1 (240) 688-4405
Fax: +1 (301) 986-0296
Email: hall@pda.org

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=3995

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