Stability Testing of Pharmaceuticals and Biopharmaceuticals Training Course
Design efficient stability studies that are suitable for global marketing. Be able to carry out appropriate stability studies and manage stability samples and facilities, learn how to save resources on stability testing and improve the likelihood of regulatory approval of stability protocols.
Details
Course overview
By attending this intensive two-day seminar, delegates will learn how to:
- Carry out appropriate stability studies and manage stability samples and facilities
- Design stability studies that are suitable for global marketing
- Increase the likelihood of studies receiving regulatory approval
- Save resources on stability testing with potential large financial savings
A series of practical exercises will take place throughout the programme to give participants the opportunity to apply their knowledge under the guidance of our experienced trainers.
Please note that we are delighted to confirm that this course will now also include particulars of the stability of biopharmaceuticals.
Benefits of attending:
- Comply with stability requirements for new and existing drug substances, products and line extensions
- Gain knowledge on storage tests, conditions and protocols
- Learn how to design highly efficient protocols for global marketing with potentially large financial savings
- Discover how to manage stability samples and facilities
- Understand what stability testing is required following changes to a product
- Discuss data treatment, shelf-life assignment and extrapolation
Who should attend?
Personnel involved in:
- Stability testing of pharmaceuticals and biopharmaceuticals
- The design of stability protocols
- The management of stability samples and facilities
- The development of pharmaceuticals which require stability testing
- The production of regulatory documents which include stability data
- Quality assurance
Programme
Background to stability testing and guidelines
- The rationale for stability testing
- Relevant guidelines
Storage tests, conditions and protocols
- Tests for drug substance and product types
- Storage conditions and periods required
- Typical protocols
- Developing global stability protocols
- In-use testing
Exercise 1: Designing a simple stability protocol
Management of stability samples and facilities
- Sample management
- Validation of storage facilities
- How to treat excursions from condition
Requirements for existing products, line extensions and variations
- Guidelines available (ICH, EU and USA)
- Requirements for active ingredient
- Requirements for product
- Requirements for variations to marketed products
Exercise 2: Designing a more complex stability protocol
Data treatment, shelf-life assignment and extrapolation
- When is statistical treatment required?
- How much extrapolation beyond real-time data is allowable?
- Presentation of data in submissions
- Setting shelf-life specifications
Exercise 3: Data treatment
Biopharmaceutical stability
- ICH Q5C and regulatory guidance
- Complexity associated with biopharmaceuticals
- Stability-indicating assays for biopharmaceuticals
- Stability considerations for new modalities
Light stability testing
- ICH Q1B guidelines
- Light sources
- Required exposure
- Problems in light testing
Packaging considerations
- Guidelines
- Requirements when changing packaging
- Demonstrating equivalence
- Permeation considerations
- Interaction studies
Exercise 4: Packaging
Sundry considerations
- Bulk stability
- Manufacture in zones III/IV to be sold in zone I
- Out-of-specification in stability
Matrixing and bracketing stability studies
- Bracketing designs
- Matrixing designs
- ICH Q1D guidelines
- What is acceptable for bracketing and matrixing?
Exercise 5: Designing efficient stability protocols
Presenters
Allan Watkinson (More...)
Allan Watkinson, Director of Biopharmaceutical Development CMC, Covance CRS Analytics Ltd. Allan has many years’ experience in a wide range of CMC activities from process development to biopharmaceutical drug product formulation, and extensive knowledge of protein analytics. As Principal Investigator he has been the technical lead in the development of cold-chain-free thermostable vaccines. Furthermore, he has been instrumental in developing novel analytical techniques for understanding protein structure in particulate biopharmaceutical formulations.
Allan’s main focus now is providing scientific expertise in the biologics analysis and all matters GMP CMC for biopharmaceutical development. Specialities:
- Biopharmaceutical analytical development and technology transfer
- Biologics release testing
- Stability testing (including developability, accelerated and forced degradation studies)
- Biotechnology process development cGMP manufacturing
- Biopharmaceutical formulation and biologics stabilisation
Ray Munden (More...)
Dr Raymond Munden has over 40 years’ experience in pharmaceutical research and development and was formerly Head, Analytical Services Europe for GlaxoSmithKline. He has led project teams that developed many new chemical entities and their pharmaceutical products that were successfully taken to market. Dr Munden has particular expertise in stability protocol design and testing, stability storage facilities, experimental design and degradation chemistry. He is now a consultant for all aspects of pharmaceutical development.
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1-2 Dec 2021 Live webinar |
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1-2 Dec 2021 Live webinar |
GBP 1,299 1,099 EUR 1,859 1,579 USD 2,098 1,786 Until 27 Oct* |
Enrol now
to attend Live webinar |
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14-15 Jul 2022 Live webinar |
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14-15 Jul 2022 Live webinar |
GBP 1,299 1,099 EUR 1,859 1,579 USD 2,098 1,786 Until 9 Jun 22* |
Enrol now
to attend Live webinar |
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* Note the early booking discount cannot be combined with any other offers or promotional code