Stability Testing of Pharmaceuticals and Biopharmaceuticals

Design efficient stability studies that are suitable for global marketing. Be able to carry out appropriate stability studies and manage stability samples and facilities, learning how to save resources on stability testing and improve the likelihood of regulatory approval of stability protocols.

7-8 Jul 2020

& 2-3 Dec 2020

GBP 1,499
EUR 2,099
USD 2,338

Book now

Course overview

By attending this comprehensive seminar, delegates will learn how to:

  • Carry out appropriate stability studies and manage stability samples and facilities
  • Design stability studies that are suitable for gloabl marketing
  • Increase the likelihood of studies receiving regulatory approval
  • Save resource on stability testing with potential large financial savings

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 day one

Delegate introductions
Background to stability testing and guidelines

  • The rationale for stability testing
  • Relevant guidelines Refreshments

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 one

  • 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 two

  • 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 three

  • Data treatment

Programme day two

6 Light stability testing

  • ICH Q1B Guidelines
  • Light sources
  • Required exposure
  • Problems in light testing

Packaging considerations

  • Guidelines available
  • Requirements when changing packaging
  • Demonstrating equivalence
  • Permeation considerations
  • Interaction studies

Exercise four

8 Biopharmaceutical stability

  • ICH Q5C and regulatory guidance
  • Complexity associated with biopharmaceuticals
  • Stability-indicating assays for biopharmaceuticals
  • Stability considerations for new modalities

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 five

  • Designing efficient stability protocols

Exercise five (continued)

Presenters

Ray Munden (7-8 Jul 2020, 2-3 Dec 2020)

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.

Allan Watkinson (7-8 Jul 2020)

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

Book now

7-8 Jul 2020
7-8 Jul 2020 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now
2-3 Dec 2020
2-3 Dec 2020 Venue not yet confirmed GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now

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Previous customers include...

  • Allergy Therapeutics (UK) Ltd.
  • Astrazeneca
  • Bard Pharmaceuticals
  • Bard Pharmaceuticals Ltd
  • Benta SAL
  • Bio Products Laboratory Limited
  • Calderdale and Huddersfield Solutions Ltd
  • Camurus AB
  • CHEMO Espana SL
  • Cheplapharm Arzneimittel GmbH
  • Colonis Pharma
  • Dr. E. Graeub AG
  • GlaxoSmithKline Vaccines
  • Laboratorios Almirall S A
  • LEK Pharmaceuticals d.d.
  • LGC
  • MeiraGTx
  • Mexichem UK Limited
  • Novo Nordisk A/S
  • orphan europe
  • Perrigo
  • Recipharm
  • RPH Pharmaceuticals AB
  • Sanofi
  • Saudi Food and Drug Authority
  • Seven Seas Ltd
  • Torbay Pharmaceuticals
  • Torbay Pharmacy Manufacturing Unit
  • Trio Medicines
  • Vericore Limited

The content was great and covered a lot of areas and aspects. The presentation had a practical flow to the topics. The speaker was very keen on helping and answering any questions.

Holly Harvey, QC Stability Analyst, AstraZeneca Operations

[The speaker was] friendly and helpful. A great course to further understanding of stability. Ray has a wealth of knowledge which was much appreciated.

Emma Grace Hill, Stability Coordinator, Perrigo

Very good, informative, good pace.

Tim Liddy, QC Supervisor, Perrigo UK

Covered all I needed

Claire McGuinness, Research Chemist, Mexichem UK Limited

Very good, good spaced breaks andgood facilities. Good timings and content

Ania Masters, Section head of stability, Bard Pharmaceuticals

Very well managed and presented course, thank you

Jane Stevens, Stability Analyst, Torbay Pharmacy Manufacturing Unit

Very knowledgeable and patient speaker, useful practical workshops, found content covered what I needed and introduced all relevant guidelines that I needed

Joanna Seiffert, Senior Principle Scientist, Trio Medicines

Excellent, content covered all expected aspects. Speaker was highly knowledgable

James Murray, Medical Chemist, Mexichem UK Limited

Well organised, good break structures, good amount of content

Joanna Seiffert, Senior Principle Scientist, Trio Medicines

Well run and presented course. Comprehensive material. Approachable speaker

Lola Cascino, QC Scientist, G-Pharm Ltd

Very useful

Jonathan Purdye, Chemistry Laboratory Manager, Torbay Pharmacy Manufacturing Unit

Informative, well presented, left me feeling clued up about stability, speaker very good at making you think in new ways to solve issues as well as real examples.

Liam O'Malley, R&D Scientist, TEVA

Really good

Thundiyil Pintoo, R&D Analytical Laboratory Manager, Ginsana SA

Very comprehensive but digestible.

Matthew Lait, Regulatory Affairs Officer, RPH Pharmaceuticals AB

Speaker knows his stuff. He answered all questions to the best of his ability. He was very nice and professional.

yetunde Bode, Regulatory Affairs Team Leader (UK Team), RPH Pharmaceuticals AB

Ray is an expert in the field and his knowledge, enthusiasm an willingness to answer questions and target as we go have made the training interactive and enjoyable. Sometimes the pace of going through the slides felt a bit high. I do appreciate the time is limited.

Blagovesta Tomova, Senior Scientist , LGC

Speakers were very helpful and experienced

Lisa Cole, Senior Medical Information Officer, Fresenius Kabi

Useful course with applied knowledge information

Gill French, Astrazeneca

Enjoyable, good content. Able to answer all my questions.

Mark Bell, Bard Pharmaceuticals

Great content, well delivered.

Mark Bell, Bard Pharmaceuticals

The training was well organized. The speaker was receptive to participant comments and questions. The content was organized and easy to follow. The materials distributed were pertinent and useful. Thank you for an interesting course!

Sandra Lickova, Product Development & Regulatory Affairs Manager, Dr. E. Graeub AG

It is a good course about stability

Maria Jose Fernandez, CHEMO Espana SL