Stability Studies Conference USA

Registration and light breakfast from 08:30 am.

Start the day by connecting with fellow stability professionals, quality leaders, formulation scientists, and industry experts from across the pharmaceutical and life sciences sectors. Enjoy a light breakfast while exploring the latest trends, challenges, and innovations shaping stability programs today.

Join us as we celebrate the fifth year of the Stability Studies Conference and mark an exciting milestone with our first event in the United States. Stephen Delaney will set the stage for a day of learning, collaboration, and discussion, highlighting the critical role stability studies play in accelerating product development, ensuring compliance, and safeguarding product quality throughout the lifecycle.

Before we begin the day’s presentations, we’ll take a step back and look at the bigger picture. What are the most pressing challenges facing stability professionals today?

Drawing on insights gathered through Q1 Scientific’s Stability Strategy Sessions, Lunch & Learn events, industry conferences, and ongoing conversations with pharmaceutical, medical device, and life sciences companies, this interactive opening session will explore the themes, questions, and concerns that are shaping stability programs across the industry.

From regulatory change and resource constraints to study design, storage strategies, data management, and risk mitigation, we’ll highlight the challenges being discussed most often by stability professionals and explore why these topics continue to demand attention.

This session is designed to start discussion, encourage collaboration, and set the tone for a day focused on shared learning and practical problem-solving.

Live Audience Poll

We’ll also hear directly from you through a live audience poll. What is the biggest challenge facing your stability program today?

The results will provide a real-time snapshot of the issues affecting companies across the industry and will help shape conversations throughout the conference. Attendees will have the opportunity to compare experiences, identify common concerns, and see how their own challenges align with those faced by their peers.

Why Attend?

• Gain insight into the key trends and challenges currently shaping stability programs
• Compare your experiences with those of other pharmaceutical and medical device professionals
• Contribute to a live discussion and help shape the conversation for the day
• Identify common challenges and potential areas for collaboration
• Set the context for the technical presentations and case studies that follow

What You’ll Take Away

By the end of this session, you’ll have a clearer understanding of the challenges affecting the broader stability community, valuable perspective from industry peers, and a roadmap for the topics and discussions that will be explored throughout the conference.

This isn’t a sales presentation, it’s a conversation starter. The Stability Studies 2026 Conference brings together decades of collective stability expertise, creating a unique opportunity to ask questions, share experiences, and learn from others facing many of the same challenges.

ICH provides the framework for stability. The challenge is deciding what is appropriate and expected for the product, phase of development, and patient population. This rapid fire session will cover questions such as:

• How much stability is enough to support an initial IND, including for key drug substance intermediates?
• If a result fails, can the program recover, especially before the IND is filed? How should a T=0 release OOS or a failure at the final accelerated timepoint be evaluated, and what does it mean for product quality and patient risk?
• Data integrity ultimately comes down to whether you can trust the data. Are system suitability failures being counted and trended, or dismissed because no reportable result was generated? Are reference standard trends being evaluated as part of the analytical control strategy?
• From shipment through administration, what additional stability assessments are needed? How should shipping temperature excursions be evaluated? What in-use stability data are needed for a sterile drug product diluted before infusion to enable clinical sites to locally source ancillary dosing components rather than requiring the sponsor to supply them?

Attendees will leave with practical, phase appropriate approaches for designing stability studies, evaluating unexpected results, and learning how these challenges have been addressed in practice.

Take a well-earned break and continue the conversations started throughout the morning. Grab a coffee, enjoy light refreshments, and reconnect with colleagues, speakers, and fellow attendees.

Some of the most valuable conference insights come from informal discussions between sessions. Use this time to ask follow-up questions, exchange experiences, and build connections with peers who share many of the same stability, quality, and regulatory challenges.

Why attend?

• Network with stability professionals and industry experts
• Discuss key learnings from the morning sessions
• Share experiences and best practices
• Explore potential collaborations and new connections

Gene therapy is an emerging therapeutic approach with the potential to treat genetic diseases by delivering genetic material into patients to modify or correct faulty genes. These therapies offer promising benefits but also come with unique challenges, especially in maintaining the stability of the products over time and continuous clinical supply. Well defined stability strategy ensures that gene therapy products remain safe and effective throughout their shelf life, supporting successful clinical outcomes and regulatory approval.

Understanding how gene therapy products degrade through physical, chemical, and environmental influences is essential for identifying risks to product quality and efficacy. By studying degradation pathways and establishing robust Critical Quality Attributes (CQAs)—such as Potency, Viral Genome Titer, Viral Particle Titer, % DNA-containing Capsids, Aggregation, and Capsid Protein Purity one can detect early signs of instability and implement effective controls to preserve product quality, efficacy, and safety. Continuous monitoring of these CQAs across the product lifecycle supports both shelf-life assignment and extension plans, ensuring gene therapy products remain safe, effective, and compliant with regulatory requirements.

This presentation will highlight strategies for analyzing degradation and CQAs, stability study design and a phase-appropriate, risk-based framework that integrates forced-degradation insights with early real-time, accelerated, and stressed stability to justify initial shelf-life assignment and to enable systematic future extensions.

Understanding degradation pathways is critical to ensuring the safety, quality, and shelf life of active pharmaceutical ingredients (APIs) and formulated drug products (DPs). During storage, APIs and DPs may degrade due to exposure to oxygen, moisture, light, or elevated temperatures. In formulated products, these risks are compounded by complex interactions between the API and excipients, often leading to unexpected or accelerated degradation pathways.

In this presentation, Darryl will walk through how stability‑driven degradants are identified, investigated, and structurally characterised when they exceed regulatory reporting or qualification thresholds. He will outline the analytical challenges associated with degradant profiling and explain how definitive structural confirmation is achieved using advanced techniques such as high‑resolution mass spectrometry (HRMS), preparative chromatographic isolation, and nuclear magnetic resonance (NMR) spectroscopy.

Drawing on case studies from Cambrex Durham, Darryl will demonstrate a practical, science‑led approach to degradant identification and structural elucidation, highlighting decision‑making strategies, analytical workflows, and regulatory considerations that support robust stability programs and protect patient safety.

One of the most highly rated aspects of previous Stability Studies Conferences has been the opportunity to connect with peers facing similar challenges. Stability Exchange has been specifically designed to make those connections easier, more meaningful, and more valuable.

Stability Exchange offers a fun, focused, and low-pressure way to meet fellow attendees. This interactive networking session brings stability professionals together through a series of short, facilitated conversations focused on stability challenges. You’ll meet professionals from pharmaceutical, medical device, and life sciences companies, share experiences, compare approaches, and learn how others are navigating complex stability requirements.

Over 30 minutes, you’ll rotate through short, small-group conversations with other stability professionals to share experiences and start conversations that can continue afterwards. Each round includes a prompt or stability-related challenge to start a conversation, so there’s no need to prepare or worry about what to say.

We know networking can feel overwhelming, especially in a large conference setting. That’s why this session is structured to be welcoming and easy to join, whether you’re an introvert, new to the field, or simply looking to expand your network.

Whether you’re looking for fresh ideas, expert advice, future collaborators, or simply reassurance that others face the same challenges you do, Stability Exchange provides a welcoming environment to start those conversations.

Why attend?

• Meet fellow stability professionals from across the industry
• Exchange practical ideas and best practices
• Discuss common challenges in a relaxed setting
• Build valuable professional connections
• Expand your stability network beyond your own organization

As the conference draws to a close, join us for a complimentary lunch and continue the conversations started throughout the day. This informal networking session provides a valuable opportunity to discuss key takeaways, exchange ideas, and build relationships with stability professionals from across pharmaceutical, medical device, and life sciences companies.

Whether you want to ask more questions about a presentation topic, seek advice on a stability challenge, explore potential collaborations, or simply connect with peers facing similar regulatory and operational demands, this final networking session offers the perfect setting to do so.

Take the opportunity to meet our speakers, connect with the Q1 Scientific and Cambrex teams, and continue expanding your professional network within the stability community.

A complimentary shuttle service will be available following lunch, providing convenient transport to the Q1 Scientific Durham facility for attendees who wish to join the site tour.

Continue the conversation as you travel on our complimentary shuttle service to the Q1 Scientific, Durham stability storage facility. Use this time to connect with peers, discuss insights from the facility tour, and share experiences and challenges from your own stability programs.

This exclusive facility tour provides a rare opportunity to explore Q1 Scientific’s state-of-the-art GMP-compliant stability storage facility. Discover how environmental monitoring, risk management, temperature mapping, and operational excellence come together to support stability programs for some of the world’s leading pharmaceutical and medical device companies.