Stability Studies 2023 Conference

How do you approach different aspects of managing and evaluating stability studies across the product life cycle efficiently while meeting regulatory requirements? Download the presentation from our Stability Studies 2023 conference to learn more.

Download the Stability Studies 2023 conference presentation

What happened at the Stability Studies 2023 conference?

The second annual Stability Studies Conference on Wednesday 18th of October 2023, brought together industry experts to share their insights on the latest trends and best practices in stability studies and product development.

Featuring a mix of presentations and discussions, this conference provided ample opportunities for attendees to network and learn from their peers. From gaining insights into regulatory requirements to discovering innovative approaches and expanding professional knowledge and skills, attendees left the conference better equipped to excel in their roles.

To learn more about the conference, please visit our dedicated Stability Studies conference website.

Guest speakers and presentations

Product development and stability considerations for combination products in the EU – A NB perspective on the key areas to be considered and common gaps in data

Theresa Jeary, Principal Technical Specialist, Medicinal & Biologics at BSI

In this session, Theresa covered the complexity of Combination Product legislation in the EU.  Theresa also provided a summary of the requirements for each type of combination and look at key development considerations for both MDR Article 117 Products and MDR Rule 14 Devices.

How stability testing impacts the development of drug products

Darryl Souness, Head of Analytical at Cambrex

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 covered:

  • 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

A practical approach to stability program compliance

Kate Coleman, Principal Consultant at Arriello

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 covered the regulations and requirements, common issues with stability programs, the QP perspective and how to navigate the management of different types of stability programs.

Stability studies in support of pharmaceutical development

Dr. Mark Powell, Director of MP Scientific

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 briefly outlined the QbD model and then considered key stability studies during pharmaceutical development.

During this presentation, Dr. Mark Powell discussed:

  • 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

Revolutionising pharma: How AI will transform process development

Dr. Niamh Mac Fhionnlaoich, Research Fellow at APC

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 reviewed 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.

Q1 Scientific Belgium: A new facility for stability storage services in Europe

Cécile Jacoby, General Manager Q1 Scientific Belgium

Q1 Scientific is a leading provider of environmentally controlled stability storage services to the pharmaceutical, medical device and life sciences industries. In 2023, Q1 Scientific opened a new 20,000 square feet facility in Belgium, expanding its offering across Europe and providing faster and more flexible solutions to customers. In this presentation, Cecile Jacoby, the General Manager of Q1 Scientific Belgium, shared her experience and insights on setting up a new facility for stability storage services in Europe. Cecile covered the:

  • Rationale and vision behind Q1 Scientific’s expansion in Europe
  • Challenges and opportunities of establishing a new facility in Belgium
  • Design and operation of the state-of-the-art temperature-controlled and monitored storage facility
  • Quality and regulatory aspects of providing stability storage services in Europe