Stability Studies Conference 2023

How can you ensure the quality and safety of drugs from start to finish? Analytical testing is essential for ensuring the quality and safety of drugs throughout their development and production stages. It helps to confirm the chemical properties of the drugs and to detect any potential issues that could hinder their progress. Therefore, having reliable, precise and high-quality analytical support for your testing needs is vital.

During this presentation, Darryl will cover:

• The importance of early method development with regard to stability testing
• The role of forced degradation and its impact on method development
• Initial elucidation of unknown impurities during early-stage development to assist in method development

Followed by a Q&A session with Darryl Souness.

With over 20 years of experience in the pharmaceutical industry, Kate is a practising Qualified Person, Principal Consultant, Lead Auditor and an SME in several areas including Quality Control and Stability.

In this presentation, Kate will cover the regulations and requirements, common issues with stability programs, the QP perspective and how to navigate the management of different types of stability programs.

Followed by a Q&A session with Kate Coleman.

Pharmaceutical manufacturers are now expected to adopt a Quality by Design (QbD) approach when developing their drug products. The critical elements to successful QbD are product understanding and risk management, which are achieved by conducting appropriate experiments during development. This presentation will briefly outline the QbD model and then consider key stability studies during pharmaceutical development.

During this presentation, Dr. Mark Powell will discuss:

• Introduction to Quality by Design
• ICH Q8 (Pharmaceutical Development) – stability requirements
• API and drug product stress studies
• Excipient compatibility and prototype stability studies
• In-use/reconstitution stability studies

Followed by a Q&A session with Dr. Mark Powell

AI in our everyday lives has already become commonplace, from the facial recognition that unlocks our phones to digital assistants like Siri and Alexa.  The pharmaceutical industry has already benefitted from AI in drug discovery and clinical trials. Still, as cutting-edge investigations delve into pivotal domains like reaction kinetics and crystallization design, the potential to revolutionize pharmaceutical process design becomes increasingly evident.  This talk will review some of the current research being done in:

• Reaction design
• Crystallisation
• Particle property prediction

And how these developments will improve efficiency while reducing waste and cost, ultimately accelerating the delivery of a high-quality product to the patient.

Followed by a Q&A session with Dr. Niamh Mac Fhionnlaoich