- email:registration@pti-europe.co.uk
- phone:+44 (0) 20 7017 7481
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CMC Analytical, Comparability and Stability Studies for Biotechnology Products
2 - 3 October 2013 , Radisson Blu Edwardian Grafton
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PRACTICAL SESSIONS
What are the expectations for heterogeneity in biotechnology products?DISCUSSION SESSIONS
discussion of ongoing resources for biotechnology analytical CMC issuesCOMPREHENSIVE OVERVIEW
...of all relevant regulatory, technical and wuality elements necessary to assure successful designKEY DELIVERABLES
...from each phase of development will be illustrated.
CMC Analytical, Comparability and Stability Studies for Biotechnology Products
Course Objectives
This practical 2-day training course presents all of the regulatory, technical and quality elements necessary to produce successful analytical test methods, product reference standards, comparability studies and stability protocols for biotechnology products in the US and EU.
This course will provide attendees with a clear, concise, but comprehensive overview of all relevant regulatory, technical and quality elements necessary to assure successful design, implementation and documentation of the required CMC analytical and stability studies for biotechnology products, including emerging biosimilar products. Key deliverables from each phase of development will be illustrated. Current ‘hot-button’ CMC analytical and stability issues will be presented, and strategies for preventing (or remediating) gaps will be presented.
Key Topics Include...
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Photostability |
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Stability Testing |
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Forced Degradation |
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Stress Testing |
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Brackating and matrixing |
Discussion topics:
- What are the 9 required analytical CMC studies?
- What are the 4 key elements for setting specs?
- What are 7 current and emerging hot-button items?
Attendees will be given a CD containing a complete set of all regulatory documents and industry white papers currently applicable to biotechnology product analytical CMC requirements that covers the entire product development lifecycle.
Dates and Venues
19 Mar 2013 - 20 Mar 2013
Radisson Blu Edwardian Grafton
02 Oct 2013 - 03 Oct 2013
Radisson Blu Edwardian Grafton
Why you should attend
- Create compliant stability protocols
- Ensure EU and FDA regulatory compliance
- Identify specifications for release
What Will You Learn?
Clarify the latest CMC regulatory requirements for biotech products to ensure successful marketing applications
Assess comparability and stability considerations for biotech product specification
Design and develop your biotech stability protocols by identifying the key practical details to address
Validate your stability testing methods appropriate for each phase of development
Identify which characteristics of a biotech product require analytical assessment
Follow the ICH, FDA and USP guidelines for analytical method validation
Identify and implement key considerations for biotechnology laboratory testing
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03 Sep 2013 - 04 Sep 2013
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