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Parenteral Drug Association Connecting People, Science and Regulation ®

2017 PDA Endotoxins Workshop

Oct 18 - Oct 19, 2017 |
Oct 19, 2017 |
Bethesda North Marriott Hotel & Conference Center | Bethesda, MD
  • Workshop
  • Western Hemisphere Events
Exhibition: October 18-19
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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 2017 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 the Limulus Amebocyte Lysate (LAL) Assay and Endotoxin Structure and Diversity
  • Data Integrity
  • Beta-Glucans: Practical Issues Associated with Pharmaceutical Manufacturing
  • Setting Endotoxin Specifications
  • Monocyte Activation Test
  • BET Laboratories: Practical Advice

Best practices for setting endotoxin specifications will be reviewed with case studies presented in small breakout groups, giving participants the opportunity to discuss actual problems and potential solutions. This Workshop will present practical approaches to endotoxin testing that participants can use in daily work and laboratory operations.

Contact

Brooke Schneider, CMP
Manager, Programs
Tel: (301) 656-5900 ext. 111
Email: schneider@pda.org

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

Exhibition Inquiries
David Hall
Vice President, Sales 
Tel: +1 (240) 688- 4405
Email: hall@pda.org

Course Inquiries
Stephanie Ko
Senior Manager, Lecture Education 
Tel: +1 (301) 656-5900 ext. 151
Email: ko@pda.org

Wednesday, October 18, 2017

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

1:15 p.m. – 1:30 p.m.
Welcome and Opening Remarks from Conference Co-Chair
Jennifer Farrington, PhD,
 Associate Director, Regulatory Affairs, Associates of Cape Cod, Inc.

1:30 p.m.– 3:30 p.m.
P1: Opening Plenary: Academic Perspectives on the Limulus Amebocyte Lysate Assay and Endotoxin Structure and Diversity
Moderator: Jessica V. Hankins, PhD,
 Microbiology Reviewer, CDER, FDA

Session Description: The Limulus Amebocyte Lysate (LAL) assay is the standard test method used to detect endotoxin in pharmaceutical products and medical devices. Although the overall biosynthesis of endotoxin is well conserved among Gram-negative bacteria, many organisms possess quite diverse endotoxin structures. This session will highlight the discovery and background of the LAL test and standardization of the lysate and reference standard endotoxin used in bacterial endotoxin testing. Additionally, this session will give attendees a broad overview of endotoxin biosynthesis, the structural diversity of endotoxins, and the mechanisms which regulate this enzymatic machinery.

1:30 p.m. – 2:15 p.m.
The Limulus Amebocyte Lysate (LAL) Test: Discovery, Development & Applications
Jack Levin, MD, Professor of Laboratory Medicine, University of California, San Francisco

2:15 p.m. – 3:00 p.m.
How Gram-Negative Bacteria Harden Their Armor: Diversity of Endotoxin Structure
M. Stephen Trent, PhD, Professor, Department of Infectious Diseases, The University of Georgia

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

3:15 p.m. – 7:30 p.m.
Exhibit Area Open

3:30 p.m. – 4:15 p.m.
Refreshment Break in Exhibit Area

4:15 p.m. – 6:15 p.m.
P2: Practical Issues with Endotoxin Testing and Regulatory Responsibilities of Sponsors
Moderator: Allen L. Burgenson, MS, Manager, Regulatory Affairs, Lonza Walkersville, Inc.

Session Description: This session will provide information about the regulatory responsibilities of sponsors filing New Drug Applications (NDAs) or Biologics License Applications (BLAs) applications with U.S. FDA, and practical testing information.

4:15 p.m. – 4:45 p.m.
FDA Case Studies: Problems and Solutions... or Problems and More Problems
Maria "Reyes" Candau-Chacon, PhD, Biologist, CDER, FDA

4:45 p.m. – 5:15 p.m.
Determining Endotoxins Limits for Raw Materials and APIs
Amber Dellar, Senior Operational Excellence Specialist, Pfizer Inc.

5:15 p.m. – 5:45 p.m.
Horseshoe Crabs and the Limulus Test: The Blue Bloods of Parenteral Quality Control
John A. Dubczak, General Manager Endotoxin and Microbial Detection, Charles River Laboratories, Inc.

5:45 p.m. – 6:15 p.m.
Questions and Answers/Discussion

6:15 p.m. – 7:30 p.m.
Networking Reception in Exhibit Area

Thursday, October 19, 2017

7:00 a.m. – 4:30 p.m.
Registration Open

7:00 a.m. – 8:30 a.m.
Continental Breakfast

7:15 a.m. – 8:15 a.m.
Breakfast Session: Data Integrity
Moderator: Jennifer Farrington, PhD, 
Associate Director, Regulatory Affairs, Associates of Cape Cod, Inc.

Session Description: This session will provide the latest regulatory perspective on Data Integrity and Part 11 compliance specific to endotoxin testing. We will cover why it is a concern to the Regulatory authorities and areas of concern during Limulus Amebocyte Lysate (LAL) testing.

7:15 a.m. – 7:45 a.m.
Regulatory Representative Invited

7:45 a.m. – 8:15 a.m.
Questions and Answers/Discussion


8:30 a.m. – 10:00 a.m.
P3: Beta-glucans: Practical Issues Associated with Pharmaceutical Manufacturing, Effects on Bacterial Endotoxin Testing, and Potential Impact on Patient Safety
Moderator: Jessica V. Hankins, PhD, 
Microbiology Reviewer, CDER, FDA

Session Description: Beta-glucans are large polysaccharides found in the cell walls of various eukaryotic and prokaryotic organisms. These polysaccharides possess immunostimulatory properties and are potential contaminants of parenteral drugs and medical devices. This session will focus on the structure (1→3)-β-D-glucan, its sources as a contaminant, its effect on LAL-based endotoxin testing, mitigation approaches, and potential impact to patient safety.

8:30 a.m. – 9:00 a.m.
(1→3)-β-D-Glucan: Properties, Sources, Bacterial Endotoxins Test Interference and Mitigation Strategies
Malcolm A. Finkelman, PhD, Director, Clinical Development, Associates of Cape Cod, Inc.

9:00 a.m. – 9:30 a.m.
Parenteral Safety of Beta-Glucans
Christine Schubert, PhD, Roche Pharmaceutical Research and Early Development, Roche Innovation Center Basel

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

9:45 a.m. – 4:15 p.m.
Exhibit Area Open

10:00 a.m. – 10:45 a.m.
Refreshment Break in Exhibit Area

10:45 a.m. – 12:50 p.m.
Concurrent Sessions
Attendees will participate in both breakouts, each 60 minutes long. After Session 1, attendees will switch and the breakouts will be repeated.
Session 1: 10:45 a.m. – 11:45 p.m. | Session 2: 11:50 a.m. – 12:50 p.m.

Session 1

Group A – Case Study 1: Setting Endotoxin Specifications
Moderator: Jay Bolden, Associate Senior Consultant Biologist, Global Quality Laboratories, Eli Lilly and Company

Session Description: Endotoxin specification calculations for injectable drug products are harmonized in the major compendia. This session will present a case study and give participants the opportunity to create a drug product and drug substance endotoxin specification control strategy, while mitigating for unusual circumstances and balancing considerations for patient safety, the threshold pyrogenic dose constant, analytical and process capabilities, and reliable market supply.

10:45 a.m. – 11:05 a.m.
Review of Case Study

11:05 a.m. – 11:25 a.m. 
Small Group Discussion

11:25 a.m. – 11:45 a.m.
Group Reports

Group B – Case Study 2: Setting in-Process Endotoxin Limits | Room B
Moderator: Friedrich von Wintzingerode, PhD, Senior Manager Microbiology, Roche Diagnostics GmbH

Session Description: There is a lack of detailed guidance for setting endotoxin in process limits (alert levels and action limits) for biologics. This session will present a case study which allows participants to understand the underlying rationales and challenges. Aspects of method alignment between different production sites will also be discussed.

10:45 a.m. – 11:05 a.m.
Review of Case Study

11:05 a.m. – 11:25 a.m. 
Small Group Discussion

11:25 a.m. – 11:45 a.m.
Group Reports


Session 2

Group A – Case Study 1: Setting Endotoxin Specifications  
Moderator: Jay Bolden, Associate Senior Consultant Biologist, Global Quality Laboratories, Eli Lilly and Company

Session Description: Endotoxin specification calculations for injectable drug products are harmonized in the major compendia. This session will present a case study and give participants the opportunity to create a drug product and drug substance endotoxin specification control strategy, while mitigating for unusual circumstances and balancing considerations for patient safety, the threshold pyrogenic dose constant, analytical and process capabilities, and reliable market supply.

11:50 a.m. – 12:10 p.m.
Review of Case Study

12:10 p.m. – 12:30 p.m. 
Small Group Discussion

12:30 p.m. – 12:50 p.m.
Group Reports

Group B – Case Study 2: Setting in-Process Endotoxin Limits 
Moderator: Friedrich von Wintzingerode, PhD, Senior Manager Microbiology, Roche Diagnostics GmbH

Session Description: There is a lack of detailed guidance for setting endotoxin in process limits (alert levels and action limits) for biologics. This session will present a case study which allows participants to understand the underlying rationales and challenges. Aspects of method alignment between different production sites will also be discussed.

11:50 a.m. – 12:10 p.m.
Review of Case Study

12:10 p.m. – 12:30 p.m.
Small Group Discussion

12:30 p.m. – 12:50 p.m.
Group Reports

12:50 p.m. – 2:00 p.m.
Networking Luncheon

2:00 p.m. – 3:30 p.m.
Small Group Discussion: Pyrogen Test Comparison
Moderator: Friedrich von Wintzingerode, PhD, Senior Manager Microbiology, Roche Diagnostics GmbH

Session Description: During this session, the main difference between the rabbit pyrogen test (RPT) and the monocyte activation test (MAT) on one hand (biological impact of the sample) and the bacterial endotoxins test (BET) on the other hand (quantification of Endotoxin) will be illustrated. The relevance of Non-Endotoxin Pyrogens (NEP) and synergistic effects will be discussed. The legal and regulatory implications of the MAT in Europe and the US will be highlighted.

2:00 p.m. – 2:25 p.m.
Monocyte Activation Test: Industry Perspective
Ned M. Mozier, PhD, Senior Director, Pfizer Inc.

2:25 p.m. – 2:50 p.m.
Monocyte Activation Test: Development
Ingo Spreitzer, Deputy Head, 1/3 Microbial Safety, Paul-Ehrlich-Institut

2:50 p.m. – 3:30 p.m.
Small Group Discussion

3:30 p.m. – 4:15 p.m.
Refreshment Break in Exhibit Area

4:15 p.m. – 5:45 p.m.
P4: BET Laboratories: Practical Advice
Moderator: Jennifer Farrington, PhD, 
Associate Director, Regulatory Affairs, Associates of Cape Cod, Inc.

Session Description: Whether you use the Bacterial Endotoxin Test to analyze in process materials, finished pharmaceutical drugs, medical devices, biologics or water systems, proper laboratory controls, and understanding of the test is critical to success. This session will explore Limulus Amebocyte Lysate (LAL) test interferences and essential laboratory controls and assay set up. Attendees will leave with practical advice to solve common inhibitory or enhancement problems as well as a more extensive knowledge of areas to look out for when setting up a new laboratory and ongoing review of the existing labs.

4:15 p.m. – 4:45 p.m.
Detection of Endotoxins in Pharmaceutical Operations
John A. Dubczak, General Manager Endotoxin and Microbial Detection, Charles River Laboratories, Inc.

4:45 p.m. – 5:15 p.m.
Laboratory Prerequisites for a Successful Bacterial Endotoxins Test
Veronika Wills, MSc, Associate Manager, Technical Services, Associates of Cape Cod, Inc.

5:15 p.m. – 5:45 p.m.
Questions and Answers/Discussion

5:45 p.m.
Closing Remarks from Conference Co-Chair
Friedrich von Wintzingerode, PhD, Senior Manager Microbiology, Roche Diagnostics GmbH

Conference and Workshop Registration | October 16-19, 2017

Member

Before August 4, 2017
$3,340

August 4 - September 5, 2017
$3,790

After September 5, 2017
$4,240

Non-member

Before August 4, 2017
$3,819

August 4 - September 5, 2017
$4,269

After September 5, 2017
$4,719


Workshop Registration | October 18-19, 2017

Member

On or before September 5, 2017
$1,495

After September 5, 2017
$1,695

Non-member

On or before September 5, 2017
$1,695

After September 5, 2017
$1,895


Government/Health Authority/Academic

Member

On or before September 5, 2017
$700

After September 5, 2017
$700

Non-member*

On or before September 5, 2017
$800

After September 5, 2017
$800


Student

Member

On or before September 5, 2017
$280

After September 5, 2017
$280

Non-member*

On or before September 5, 2017
$310

After September 5, 2017
$310


All prices in US dollars.

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

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.

Group Registration Discount

Register 4 people from the same organization as a group (at the same time) for the Workshop and receive the 5th registration free. Other discounts cannot be applied.

Special Dietary Requirements

Please let us know if you have any special dietary requirement we may accommodate. 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 by August 17, 2017 your credit card will be charged the prevailing rate.

SUBSTITUTIONS: If you are unable to attend, substitutions can be made at any time, including on site at the prevailing rate. 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). If your written request in received on or before August 17, 2017, you will receive a full refund minus a $200 processing fee. After that time, no refunds or credit requests will be approved. On-site registrants are not guaranteed to receive Workshop 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. 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: $264.00, plus applicable state and local taxes.

Cut Off Date: Monday, September 18, 2017 (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 Endotoxin Workshop to receive the PDA group rate. Check in time is 4:00 p.m., and check out time is 12:00 noon.

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 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.

Find the Best Exhibit and/or Sponsorship Option for Your Ideal Audience

The 2017 PDA Endotoxins Workshop will enable you to connect key decision makers from the pharmaceutical manufacturing industry.

High-profile sponsorships are available for lanyards, notepads, tote bags, pens, refreshment breaks, luncheons and the Networking Reception. Don't miss this opportunity to strengthen brand image, increase visibility and gain access to industry leaders.

For exhibit and/or sponsorship information, please contact:
David Hall, Vice President, Sales | Cell: +1 (240) 688-4405 | Email: hall@pda.org
Alison Caballero, Senior Coordinator, Sales | Phone: +1 (301) 656-5900 x 135 | Email: caballero@pda.org

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https://store.pda.org/Meetings/Login.aspx?ID=3599

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