Registration
Welcome and opening remarks by bioMerieux
Bacterial Endotoxin Testing – Progressive Science and Sustainability
Jay Bolden

We are in the midst of a generational shift in the bacterial endotoxins test towards a more sustainable future using modern biotechnology. Attendees will learn what is changing, why change is inevitable and how it can occur. Data will be shared that illustrates equivalence between the animal-derived LAL test reagent and modern recombinant reagents. Additionally, the current regulatory and pharmacopoeial landscape will be presented including updates from the United States Pharmacopoeia Microbiology Expert Committee.

  • Jay Bolden (Senior Director – Quality – Biologist of Eli Lilly & Company)

    Jay Bolden

    Senior Director – Quality – Biologist of Eli Lilly & Company
Coffee Break
Transforming Sterility Testing in Australia: CBE Pure Solutions' Pioneering Journey
Robyn Hofer

Traditional microbiological methods are established and have been used for decades but are time consuming and take several weeks to generate results. Rapid microbial methods (RMM), on the other hand, leverage novel technologies and can provide efficient microbiological control and assurance to allow expedited release of products. Attendees will gain insights into the different RMM available, the considerations surrounding the choice of a technology, its validation and implementation and take a look into CBE Pure Solutions’ journey to implementing solid-phase cytometry technology, a first in Australia.

  • Robyn Hofer (Operations Manager at CBE Pure Solutions)

    Robyn Hofer

    Operations Manager at CBE Pure Solutions
Interactive Case Study Session
Summary and Closing Remarks

Topic Details

Bacterial Endotoxin Testing – Progressive Science and Sustainability


We are in the midst of a generational shift in the bacterial endotoxins test towards a more sustainable future using modern biotechnology. Attendees will learn what is changing, why change is inevitable and how it can occur. Data will be shared that illustrates equivalence between the animal-derived LAL test reagent and modern recombinant reagents. Additionally, the current regulatory and pharmacopoeial landscape will be presented including updates from the United States Pharmacopoeia Microbiology Expert Committee.


Transforming Sterility Testing in Australia: CBE Pure Solutions' Pioneering Journey



Traditional microbiological methods are established and have been used for decades but are time consuming and take several weeks to generate results. Rapid microbial methods (RMM), on the other hand, leverage novel technologies and can provide efficient microbiological control and assurance to allow expedited release of products. Attendees will gain insights into the different RMM available, the considerations surrounding the choice of a technology, its validation and implementation and take a look into CBE Pure Solutions' journey to implementing solid-phase cytometry technology, a first in Australia.