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Recombinant Chromogenic Assay as Alternate Methods for the Bacterial Endotoxins Test (BET)
October 30, 2020
Recombinant Chromogenic Assay as Alternate Methods for the Bacterial Endotoxins Test (BET)

Recently, there has been a lot of interest associated with the potential use of synthetic (non-animal based) reagents for bacterial endotoxin testing. This workshop will provide an in-depth overview of the global perspective on the use of such reagents, including their regulatory status.

In the hands-on portion of the workshop, we will focus on executing a recombinant kinetic chromogenic assay, testing samples and detailed data interpretation with the primary focus on comparability of the data with conventional amoebocyte lysate- based assays.
 

FEATURED SPEAKERS

Veronika Wills

Veronika Wills

Manager, Technical Services, Associates of Cape Cod

Veronika Wills

Manager, Technical Services, Associates of Cape Cod
Veronika Wills

Veronika has been working in the endotoxin industry for the past 12 years and currently manages the Technical Services department at Associates of Cape Cod, Inc. Veronika is a specialist on testing complex samples, method development, regulatory aspects of endotoxin testing, development and delivery of educational and technical contents. She attends and speaks frequently at scientific conferences and seminars globally and is an established expert on endotoxin testing. Veronika holds a Master’s Degree in Biochemical Engineering from the Institute of Chemical Technology in Prague, Czech Republic.

 

Workshop agenda

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8:30

Registration & Coffee

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9:00

Opening Remarks and Introductions

Veronika Wills, Manager, Technical Services, Associates of Cape Cod

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9:10

Overview of status of recombinant

Veronika Wills, Manager, Technical Services, Associates of Cape Cod

• Status with the US, European and Japanese Pharmacopeias
• Status with the Chinese Pharmacopeia
 

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9:50

Hands-on portion: Kinetic Chromogenic Assays

Veronika Wills, Manager, Technical Services, Associates of Cape Cod

• Preparation of the test
• Software settings
• Executing the test
 

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10:30

Coffee Break

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11:00

Data Interpretation

Veronika Wills, Manager, Technical Services, Associates of Cape Cod

• Basic data interpretation
• Comparability with LAL-based data
• Troubleshooting general issues
 

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11:40

Future outlook

Veronika Wills, Manager, Technical Services, Associates of Cape Cod

• Overview of requirements for alternate testing

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12:20

Closing Remarks

Veronika Wills, Manager, Technical Services, Associates of Cape Cod

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12:30

End of Workshop


Manager, Technical Services
Associates of Cape Cod

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As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

GLOBAL CPD

Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

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