Workshop Details

Dates

February 26, 2025

Time

1:00 pm – 2:00 pm

Cost

FREE

Location

Online

Deadline

February 19, 2025

Workshop Overview

The upcoming release of Chapter <86> to the United States Pharmacopeia will open the door for non-animal-derived reagents in endotoxin testing, including innovative methods utilizing recombinant cascade (rCR) and recombinant Factor C (rFC) reagents. This workshop will explore the integration of these sustainable methods with the Sievers Eclipse Bacterial Endotoxins Testing (BET) Platform.

Through a comprehensive case study comparing traditional Limulus Amebocyte Lysate (LAL) reagents with their non-animal counterparts, the workshop will demonstrate the efficacy and reliability of these alternative reagents across a diverse range of pharmaceutical products. Real-world samples will be analyzed to provide valuable insights into testing methodologies and the practical benefits of adopting non-animal-derived reagents.

Attendees will gain practical knowledge on how to implement rCR technology in their endotoxin testing protocols, paving the way for more ethical and sustainable practices in pharmaceutical quality control while ensuring compliance with USP <86> guidelines.

Who Should Attend​

This workshop is ideal for professionals involved in pharmaceutical quality control, laboratory managers, regulatory affairs specialists, and anyone involved in endotoxin testing. It is particularly beneficial for those seeking to stay ahead of regulatory changes and implement non-animal-derived reagents in endotoxin testing. Attendees will gain valuable insights into new methodologies, technology integration, and sustainable practices in endotoxin testing.

Workshop Outline

This workshop covers the following topics:

  • Introduction to USP <86> and the upcoming changes in endotoxin testing regulations
  • Overview of non-animal-derived reagents for endotoxin testing, including rCR and rFC technology
  • The role of the Sievers Eclipse Bacterial Endotoxins Testing (BET) Platform in supporting these sustainable methods
  • Case study comparison: Traditional LAL reagents vs. non-animal-derived reagents across various pharmaceutical products
  • Efficacy and reliability of rCR and rFC reagents in endotoxin testing
  • Practical insights into implementing rCR technology in endotoxin testing protocols
  • Ethical and sustainable practices in pharmaceutical quality control with non-animal-derived reagents
  • How rCR technology aligns with USP <86> guidelines and enhances testing practices

Learning Outcomes

Understand the Impact of USP <86> on Endotoxin Testing

Gain a comprehensive understanding of the upcoming changes to USP <86> and how they open the door for non-animal-derived reagents in endotoxin testing.

Master rCR and rFC Technology

Learn the application of recombinant cascade (rCR) and recombinant Factor C (rFC) reagents in endotoxin testing, understanding their advantages over traditional LAL reagents.

Evaluate the Efficacy of rCR Technology

Understand how rCR technology performs across a diverse range of pharmaceutical products and how it compares to traditional endotoxin testing methods in terms of reliability and accuracy.

Implement rCR Technology in Testing Protocols

Gain practical insights into integrating rCR technology with the Sievers Eclipse Bacterial Endotoxins Testing (BET) Platform and adapting testing protocols for compliance with USP <86> guidelines.

All participants will receive a certificate of attendance upon completion of the workshop.

Note: Registration closes one week prior to the start of workshop.

Beyond LAL: Embracing rCR Technology for USP Compliant Endotoxin Testing

February 26, 2025

Other Workshops Available

Meg Provenzano

Veolia Water Technologies & Solutions

Product Manager - Sievers bio-detection instruments

Meg Provenzano is the Product Manager for Sievers bio-detection instruments at Veolia Water Technologies & Solutions. She has over 10 years of experience in the bacterial endotoxin testing industry and has held several positions in Quality Control, Technical Support, and Product Management. Prior to joining Veolia, Meg was a Product Manager with Charles River Laboratories. She is customer-centric and enjoys hands-on problem solving, whether for technical issues, assay assistance, or software. Meg holds a B.S. in Marine Science and Biology from Coastal Carolina University where she focused on Bottlenose Dolphin population research.