Is your stability storage strategy up to date?
Stability storage plays a crucial role in ensuring the safety and efficacy of pharmaceutical and biological products, but is your strategy keeping pace with industry demands?
In an era of increasingly complex drug formulations, evolving regulations, and rising supply chain pressures, pharmaceutical and biotech companies must optimise their stability storage strategy to avoid compliance risks and costly delays.
The growing challenge of stability storage
As drug portfolios expand the demand for controlled storage conditions is greater than ever. Many companies face challenges such as:
- Limited in-house capacity: Growing product pipelines require more space than existing chambers can provide
- Regulatory compliance risks: Meeting ICH guidelines and regulatory requirements demands rigorous environmental control and monitoring
- Chamber failures and missed testing time points: Equipment failures or missed testing time points can put entire studies at risk
- Rising operational costs: Maintaining in-house storage is expensive, from staffing to equipment maintenance
Why more companies are outsourcing stability storage
Imagine a pharmaceutical company facing a sudden chamber failure. Without a backup plan, their entire study is at risk. This is where Q1 Scientific steps in. Partnering with a specialised provider like Q1 Scientific offers strategic advantages, including:
- 100% on-time sample pulls: No missed stability testing time points
- State-of-the-art, GMP-compliant storage: Conditions from –80°C to +50°C with full humidity control
- Risk mitigation: Backup systems and 24/7 monitoring protect valuable samples
- Scalability: Expand storage capacity without the need for capital investment
To support a product release rationale, we required some urgent short notice aging of samples. The team at Q1 were very helpful in quickly understanding our requirements and determining what they could do to support our short notice request. This allowed us to proceed with the aging plan and testing enabling the release of critical components.
How Q1 Scientific supports your stability program
At our facilities in Belgium, Ireland, and the US, we store critical pharmaceutical, biologic, and medical device stability samples for leading life science companies. By outsourcing to Q1 Scientific, our customers can:
- Focus on research and development while we handle stability storage logistics
- Ensure regulatory compliance with ICH, GMP and regulatory body standards
- Reduce costs and free up internal resources for core business priorities
We’re bringing stability storage expertise to you
Looking to connect with experts in stability storage? Our team is attending key industry events and is ready to discuss your stability storage challenges and solutions. Here’s where you can find us.
Innovative Biologics & CMC Challenges Vol. 2, Charleroi, 11 – 12 March
Stéphanie Moreau is attending the Innovative Biologics & CMC Challenges event in Charleroi tomorrow, engaging with experts on stability requirements for biologics. Many companies struggle with the stability storage of temperature-sensitive biologics. Connect with Stephanie to discover innovative solutions and best practices that can help you overcome these storage challenges.
DCAT Week 2025, New York, 17 – 20 March
Kenley Joseph is heading to DCAT in New York next week, where he’ll be meeting with pharmaceutical leaders to discuss how Q1 Scientific can support their stability storage needs. Are you facing stability storage capacity issues, failing equipment, or missed sample pull dates? Connect with Kenley to discuss how we can streamline your stability storage.
Let’s talk! What’s your biggest stability storage challenge?
What are the biggest challenges you face in managing stability storage? Contact our team to explore how Q1 Scientific can support your needs.