Effective Impurity Management within Antibody Drug Conjugates (ADCs)
Examination of Impurity Classes and How they can be Categorised, Assessed and Controlled
Event overview
| NEW COURSE |
The use of Antibody drug conjugates as therapeutic agents is hugely attractive, offering the potential to effective target delivery of a drug to specific site and thus improving efficacy while also reducing toxicity through off target effects. ADCs comprise of 3 components, a drug, a linker and a monoclonal antibody. There are often viewed as a biologic and a small molecule and thus subject to a guidance / regulatory framework covering both. But is this correct?
This Online course will examine the challenges posed in effective and appropriate management of impurities. It will examine each type of Impurity, process and product related, and crucially, the risk posed by conjugated and non-conjugated impurities. In an area lacking an appropriate guidance framework it will examine the latest thinking and how this could shape the future approach taken to effective impurity management
The course will be held over two Live Sessions as follows in UK time:
Wednesday, November 19 | 1.30pm – 5.30pm GMT
Thursday, November 20 | 1.30pm – 5.30pm GMT
Andy also runs the fantastic Practical Management of Impurities and Development of Effective and Comprehensive Control Strategies.
Next course is HERE
Course Outline - Key Topics
Session 1:
- Introduction to ADCs
- Safety profile of ADCs 30 mins
Session 2
- Impurity management – part 1
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- Overview of current regulatory thinking – issues / concerns
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- Small molecules / unconjugated impurities
- Impurity management – part 2
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- Conjugated impurities
Session 3
- Non ADC related impurities and their management
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- Mutagenic Impurities – N-Nitrosamines
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- Solvents ICH Q3C
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- Elemental impurities ICH Q3D
Session 4
- Control of ADCs
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- Specifications, phase appropriate
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- Regulatory Filing
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- Open Discussion
Benefits of Attending
By attending this course people will gain a holistic understanding of the types of impurities that are seen within ADCs and will hear about the latest proposed approach to their effective management; one based on a thorough evaluation of risk factors. This is critical in a rapidly growing area, one though that at present has no clear guidance framework
Who Should Attend
This would be of interest both to those involved in strategy development of an ADC portfolio as well as though involved in practical synthesis of ADCs. Thus it would be of interest to process chemists, pre-clinical toxicologists, analysts and regulatory affairs professionals at all levels up to VP
What's Included
The course fee includes:
- Link to watch all two live sessions
- Electronic version of the course manual*
- Course certificate
For this on line course, there will be no recordings available and *the e reader manual is NOT printable or downloadable (due to copyright). If you prefer a hard copy of the manual you will have the opportunity of purchasing a professionally printed hard copy during the booking process.
Other Information
Wiley Book Discount
Andrew is the author of the book ‘Mutagenic Impurities’ published by Wiley. They are offering a 20% discount – see more information on our blog post.
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