Clinicians have formed the view that anyone with an infection of Gram-negative bacteria can develop a life threatening prognosis caused by Bacterial Endotoxin (pyrogen, LPS, LAL, TAL, etc). As a result, it is mandatory for manufacturers to perform endotoxin testing to ensure the safety of their product.

The traditional rabbit pyrogen test (animal testing) has all but disappeared. Newer rapid methods have been developed, however, choosing which method to use can be very confusing. As technology advances, methods such as recombinant Factor C Test (rFC), have been developed and made commercially available. This seminar will explore how robust these newer test methods are compared with USP compendial methods for endotoxin testing.

To ensure that there are no threats posed to the general population from endotoxin contaminated products, Regulatory bodies approve the use of various methodologies for testing for endotoxins in manufactured products prior to market release. Pharmaceutical, Radiopharmaceutical, Biotechnology and Medical Device Industries that manufacture cGMP product all require validated bacterial endotoxin release assays.

The Seminar will provide an insight into some of the challenges currently faced within these industries – from the perspective of validation and testing, and how the production and process control of a manufacturing facility can affect the endotoxin levels of their final products. It will be a useful guide to Quality Control Analysts, Manufacturing Quality Assurance Associates, Production Associates and Management.


5:00 pm - 5:40 pm Registration

5:40 pm - 5:50 pm Introduction: Yung Dai, CAPSIG Committee Member

5:50 pm - 6:20 pm Adam Smith, Immunobiology Section, TGA Laboratories “Common Mistakes and Misconceptions with Endotoxin Testing”

6:20 pm - 6:50pm Tanya Spence and Renuk Bandaranayake, AstraZeneca “Design of Pharmaceutical Water Systems for Exclusion of Endotoxins in Parenteral Products”

6:50 pm - 7:20pm Karolina Heed, Hyglos bioMérieux “Recombinant Horseshoe Crab Factor C (rFC): The Future is Here”

7:20 pm - 7:30pm Question Time

7:30 pm - Onwards Dinner

$75 per person. Cheques payable to CAPSIG - NSW (CAPSIG is a non-profit group with annual turn-over less than the statutory limit and hence GST is not applicable).

Friday 19 July 2019

Melissa Bourke
Email: melissa.bourke@biomerieux.com

Download and Print Seminar Booking Form

NSW Upcoming Events

24 JULY 2019

Heritage Room
Canterbury-Hurlstone Park RSL
20-26 Canterbury Road, Hurlstone Park


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