Stability Testing in Biological Product Development and Manufacturing

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Quality by Design principles are being applied throughout the pharmaceutical development process and stability testing is no exception. Stability testing of biological products presents specific challenges in respect of product type and characterisation, especially the complexity of both active substances and the products.

This course covers all of the relevant regulatory, ICH and GMP guidance including stability study design and principles of QbD on Day 1. On Day 2, we look at the specifics of evaluating biological products, generation of stability data, specification setting and shelf life evaluation.

The course will include:

  • Stability Testing and QbD
  • Why is stability testing required for product registration and GMP purposes?
  • What are the stability test requirements for Clinical Trials, new, and existing products?
  • How can stability testing be applied during product development to shorten development times as well as improve product quality
  • Stability testing outsourcing - successful management and execution


  • Biological product evaluation and analytical methods
  • Product characterisation
  • Setting specifications and shelf lives
  • Ongoing stability testing of biological products for product maintenance and GMP

Start time:
8.30 Coffee/tea and registration, course proper 9.00 and we anticipate the course will finish at 17.00.

Day 1

  • Introductions
  • The life cycle approach to product development and Quality by Design
  • Stability testing in product development
  • ICH Guidance Q1A (R2) – a comprehensive review
  • Case study
  • “Effect of Processing and Formulation Variables on the stability of a salt of a weakly basic drug candidate (tablet)” Badawy et al, BMS
  • EU GMP guidance on stability testing


  • Key techniques for analysing biological products
  • ICH Q5C Stability testing of Biotechnological/Biological Products.
  • Taking account of the unique properties of biological materials.
  • “ICH Q6B Specifications: Test procedures and acceptance criteria for Biotechnological/Biological Products”.
  • Role of specifications in stability testing.
  • Putting the guidance into practice.
  • Approaches to identifying and handling out of trend data.
  • Bringing it all together – using stability data in Marketing Authorisation Applications including the Quality Overall Summary.
  • Workshop – bring your data for review and evaluation

Workshop and examples based on delegate’s interests

Group discussion, problem solving and consultancy

Additional Resources

Online access to comprehensive publications including all relevant guidance will be provided as well as colour copies of all presentations and case studies .

The course is designed for people working in:

  • Analytical and Product Development within Biotech organisations
  • Analytical Chemistry
  • Stability Testing
  • Formulation Development
  • Regulatory Affairs
  • Pharmaceutical & Biopharmaceutical Production
  • Quality Control and Quality Assurance
  • Technical Operations


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