Conference on 4th Annual Stability Testing

4th Annual Stability Testing
Examining current challenges and exploring more cost-effective strategies.
22nd – 23rd November 2010, BSG Conference Centre, London, UK

Key Speakers:

Garry Scrivens, Senior Principal Scientist, Pfizer,
David Elder, Externalization Director, GlaxoSmithKline,
Ahmed Yasin, BioPharm Analytical & Formulation Research, GlaxoSmithKline,
Dagmar Mohr, Group Head Analytical R&D and QC Biotech Products, Roche,
Simona Bohanec, Head of Regulatory Analytics, Sandoz,
Duu-Gong Wu, Executive Director, PharmaNet,
Jan Jiskra, Project leader, Synthon,
Jane Robinson, Principal Scientist, Biotherapeutics, National Institute for Biological Standards and Control,

Conference Introduction
4th Annual Stability Testing
22nd - 23rd November 2010, London, UK

Failing to conduct a proper stability testing can be very time consuming and costly for companies, and damaging to their reputation. The cost of taking NCE through the development stages can range anywhere between $800 million to $1.2 billion (source: Springer, 2009). It is therefore, important for companies to understand key factors affecting the stability profile of a potential product, and carry out an effective stability program. 4th Annual Stability Testing Conference will feature key industry
experts who will aim to share their experiences and explore key themes, including criteria for product stability, challenges associated with specific product types
(including biotechnology products). Attendees will gain latest insights into the regulations, risk management, as well as the application and limitations of stability test procedures.

Why you should attend this conference:
• Understand strategies to design and implement a compliant stability program.
• Hear the latest regulations guidelines, including FDA and ICH requirements.
• Examine when it is best to perform stability tests: at what stage in the lifecycle?
• Debate the best approaches for data management of statistical data.
• Understand the importance of risk assessment.
• Review current methods used to reduce costs.
• Explore the benefits of outsourcing.
• Discuss challenges associated with specific product testing
• Use this opportunity as a platform for future collaborations

Who should attend this conference?
Senior VPs, VPs, Chief Scientific Officers, Directors, Managers,
Professors, and Principal Investigators in:
• Stability/ Stability Testing
• Analytical Laboratory
• Formulation Development
• Contract Laboratory
• R&D
• Quality Assurance
• Quality Control
• Analytical Development
• Analytical Chemistry
• Pharmaceutical & Biopharmaceutical Production
• Product Development
• Product Submission
• Validation
• Documentation and Technical Writing
• Regulatory Affairs
• Project Management
• Technical Operations
• Regulatory Affairs

Day 1
4th Annual Stability Testing
Monday 22nd November 2010

09:00 Registration and refreshments

09:30 Opening address from the chair

09:40 US regulatory perspective on stability testing of pharmaceutical products

• The objectives of stability studies during drug development
• US regulatory requirements for stability testing of drug substances and drug products during different phases of drug development
• Regulatory and scientific considerations on design of stability protocols
• Special issues on stability testing for drugs, biological products and combination products
• Stability testing and Quality by Design (QbD)

Duu-Gong Wu
Executive Director, PharmaNet, USA,

10:20 Early screening of key stability issues of biopharmaceuticals

• Key BioPhysical and PhysicoChemical properties of proteins that are key in stability testing
• Characterisation of various pathways
• Stable Formulation options available for proteins
• Stability options and a case study
• ETC

Ahmed Yasin
BioPharm Analytical & Formulation Research, GlaxoSmithKline,

11:00 Morning refreshments.

11:20 Challenges in using bioassays in stability studies.

• For most biopharmaceuticals, testing for potency by bioassay is a required part of stability studies.
• The bioassay used must be shown to be stability indicating.
• The precision of the bioassay may limit its detection of small changes in potency.
• Interpretation of changes in potency can be complicated and usually requires complementary physicochemical data

Jane Robinson
Principal Scientist, Biotherapeutics, National Institute for Biological Standards and Control,

12:00 Thinking smart about stability testing for post market products
• Implement stability programs to answer the specific needs: Change, Ongoing, Deviation programs
• What is the risk to changing stability programs
• How do we mitigate the risk to change
• Implementing the changes

12:40 Networking lunch

13:40 Stability challenges of amorphous compounds.
• Chemical and physical stabilisation of amorphous API/drug product
• Correlations between molecular mobility and chemical stability - Learnings from Ritonavir.
• Approaches to stabilise poorly soluble drugs, some case examples.

David Elder
Externalization Director, GlaxoSmithKline,

14:20 Role of thermal methods in stability testing.
• Application of DSC:
- polymorph screening and characterization application of isothermal calorimetry.
- amorphous content quantification.
- final product stability.

Simon Gaisford,
Senior Lecturer in Pharmaceutics, The School of Pharmacy, University of London,

15:00 Afternoon Refreshments

15:20 Evaluation of stability data (Q1E ICH guideline)
• Implementation of the Q1E guideline: Evaluation of Stability Data
- Understanding and using linear regression analysis (intercept, slope, confidence intervals)
- Why to test for pool ability of batches?
- How to test for pool ability of batches?
• Using calculations to predict shelf-life and release limits
(Case studies 1–3)
• Application of linear regression analysis to long-term data for climatic zones 3 and 4

Simona Bohanec, Head of Regulatory Analytics, Sandoz

16:00 Bracketing and matrixing (B&M)
• Success in reducing stability testing
• Limitations of these procedures
• Applicability
16:40 Closing remarks from the chair
16:50 Networking drinks
Take your discussions further and build new relationships in a relaxed and informal setting.

Day 2
4th Annual Stability Testing
Tuesday 23rd November 2010

09:00 Registration and refreshments.

09:30 Opening address from the chair.

09:40 Increasing the reliability of shelf-life predictions from accelerated stability studies.
• Description of ‘accelerated stability assessment program’
• Focus on the prediction of degradation rates in the solid-state, i.e. degradation of API (active pharmaceutical ingredient) and solid-oral drug products (e.g. tablets and capsules).
• Prediction of degradation of packaged drug products, and how this tool may be used for packaging selection.
• Case studies are briefly described that demonstrate the potential power of this approach.

Garry Scrivens,
Senior Principal Scientist, Pfizer,

10:20 Statistical shelf life estimation from multiple batch stability studies.
• What do the ICH guidelines have to say about the statistical methods I should use?
• Should I use a linear or non-linear model?
• How to select the right model and test for differences between batches.
• Do I need (to be) a statistician - or - to what extent can/should the analysis be automated?

Matthew Coates,
Senior Statistical/Technical Consultant, StatSoft,

11:00 Morning refreshments

11:20 Developing fast chromatography methods to support your stability programmes from development through to registration.
• Developing Fast UPLC/Non-UPLC stability indicating methods.
• Savings that can be made by streamlining your development efforts early in the drug development cycle.
• How does the future of stability analysis look?

Mark Benger,
Director, Aptuit,

12:00 Stability testing of generic medicines.
• Understanding guidelines and regulatory requirements for generic products.
• Stability testing programme for generic products
• Specific issues on filing generics worldwide and/or different regions
• Strategies to keep costs low, including bracketing and matrixing
• Comparison of the generic product to the innovator, prove the similarity in stability through analytical testing.

Jan Jiskra,
Project leader, Synthon,

12:40 Networking lunch.

13:40 Stability testing: the case for out-sourcing.
• Assessing the benefits.
• Factors to consider when considering outsourcing.
• Choosing the right partner.

Jacinta George.
Commercial Director, Reading Scientific Services,

14:20 Monitoring and evaluation of single amino acid modifications of therapeutic monoclonal antibodies.
Modifications of single amino acids may be observed during stability testing differing in their extend and their impact on product quality. This talk comprises drivers, methodology and evaluation of the following single amino acid modifications:
- methionine oxidation.
- asparagine deamidation.
- N-terminal glutamine / glutamate cyclization.

Dagmar Mohr,
Group Head Analytical R&D and QC Biotech Products, Roche,

15:00 Afternoon refreshments

15:20 Photostability testing.
• Strategies to design a compliant photostability program.
• Analytical approaches for assessing photostability.
• Evaluation of illumination sources used for photostability testing.

16:00 Importance of risk management in predicting success.
• Why it is important to perform risk assessment at every stage of development.
• Methods for predicting success early on.

16:40 Chair’s closing remarks

16:50 End of conference.


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