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
Manager, Technical Services, Associates of Cape Cod
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
Opening Remarks and Introductions
Veronika Wills, Manager, Technical Services, Associates of Cape Cod
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.
Overview of status of recombinant
Veronika Wills, Manager, Technical Services, Associates of Cape Cod
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.
• Status with the US, European and Japanese Pharmacopeias
• Status with the Chinese Pharmacopeia
Hands-on portion: Kinetic Chromogenic Assays
Veronika Wills, Manager, Technical Services, Associates of Cape Cod
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.
• Preparation of the test
• Software settings
• Executing the test
Veronika Wills, Manager, Technical Services, Associates of Cape Cod
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.
• Basic data interpretation
• Comparability with LAL-based data
• Troubleshooting general issues
Veronika Wills, Manager, Technical Services, Associates of Cape Cod
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.
• Overview of requirements for alternate testing
Veronika Wills, Manager, Technical Services, Associates of Cape Cod
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.
Manager, Technical Services
Associates of Cape Cod
Manager, Technical Services, Associates of Cape Cod
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.
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