Celebrating World Quality Month 2025 at Abzena – Quality: Think Differently
This November, Abzena proudly celebrates World Quality Month, joining the global community in recognizing the critical role of quality and compliance in the pharmaceutical industry.
This year’s theme, “Quality: Think Differently,” reflects our commitment to challenging conventions, inspiring innovation, and strengthening our culture of quality excellence across all that we do. It’s a reminder that quality is not static, it evolves as science advances, as patients’ needs grow, and as our teams continue to push the boundaries of what is possible.
“This World Quality Month, I want to remind us of what quality really means in our work. Quality is how we earn the right to serve patients — it’s the foundation of the trust they place in us. Quality isn’t just a department’s job. It’s something we all own every day. Whether you’re in the lab, on the shop floor, or in the office, every choice we make contributes to the safety and reliability of what reaches patients. Thank you for keeping quality at the heart of everything we do.” – Sean O’Brien, COO of Abzena
How We Prioritize Quality at Abzena
At Abzena, quality is the foundation of everything we do. As a leading CDMO+CRO for complex biologics and bioconjugates, we are trusted by our partners and customers to uphold the highest standards of product safety, efficacy, and reliability throughout every stage of development and manufacturing.
Upholding that trust is both our responsibility and our purpose. We embed rigorous quality systems, continuous improvement, and scientific precision into every process, ensuring that every molecule, material, and method aligns with our shared vision of delivering life-changing therapies to patients worldwide.
Thinking differently about quality means going beyond compliance; it means anticipating needs, fostering collaboration, and finding smarter, more efficient ways to achieve excellence.
“As we continue our corporate journey of progressing our capabilities to ensure we can take our customers beyond the clinic in support of their drug launches, Quality needs to be at the forefront of everything we do. It needs to guide how we think and how we make decisions because the stakes are higher than ever.” – Geoff Glass, CEO of Abzena
Integrating Quality Across Our Processes, Personnel & Facilities
Last year, we spoke about how quality is the common thread that connects every part of the work we deliver here at Abzena. From early discovery and development through to our GMP manufacturing and commercialization services – our focus on quality drives innovation and performance. It empowers our teams to deliver reliable results, support regulatory confidence, and ultimately bring better therapies to patients faster.
With this year’s theme centered on “thinking differently”, we decided to share how we focus on quality in our processes, personnel, and facilities.
Training and Competency Development
At Abzena, our people are our most important asset. Ensuring every team member is equipped with the knowledge and skills to perform cGMP activities with confidence is central to how we operate. Continuous education keeps our organization aligned with evolving best practices and regulatory expectations. We regularly enhance our standard operating procedures (SOPs) and support our workforce through structured work instructions, classroom training, operational readiness programs, and on-the-job training to ensure consistent, high-quality execution.
Operational Readiness and Preparedness
We invest significant energy into operational readiness and preparedness for every production run, from early phase to commercial manufacturing.
Our teams execute GMP operational readiness activities at defined cadences, supported by standardized checklists that promote robustness, consistency, and early identification of potential issues before they arise.
We also leverage a comprehensive After-Action Review program following each production run, our own “lessons learned” process, ensuring we continually enhance our systems and drive improvement across all operations. These activities are at the core of how we build quality into everything we do, ensuring every customer program benefits from our commitment to excellence.
Audit Preparedness
Audit preparedness is a core element of our Quality culture. Ensuring our facilities and processes align with current regulatory expectations is essential to supporting our customers through both early-phase and commercial manufacturing. We maintain a robust internal audit program that mirrors the rigor and structure of regulatory inspections, enabling consistency, transparency, and readiness at all times. This approach supports successful customer audit outcomes and reinforces our commitment to compliance and continuous improvement.
Achieving ‘Zero Harm’ and Environmental Sustainability
The company strives to achieve a ‘Zero Harm’ target in terms of injuries to people and environmental impact:
“This principle guides how we operate and maintain our business to ensure a safe and healthy environment for our sites, employees, and neighboring communities. Our vision is to become an incident- and injury-free organization, supported by proactive safety programs, continuous improvement, and a deeply embedded safety culture.” – Sean Rasmussen, Director of EH&S at Abzena
Aligned with our safety commitment is a five-year sustainability strategy to reduce energy use, solid waste, and water consumption by 5% by 2029. We are driving this as part of site objectives and ISO14001 continual improvement initiatives —such as HVAC and high-purity water system efficiencies, site-level waste reduction initiatives, and recycling programs.
Our Commitment to Quality Excellence
“In an industry built on quality, safety, compliance, and trust, thinking differently means more than innovation it means challenging assumptions, simplifying where we can, and continuously improving how we deliver for patients. Quality is not just about adherence to standards; it’s about anticipating risks, driving efficiency, and finding smarter, more sustainable ways to achieve excellence!” Troy Wright, SVP and Global Head of Quality at Abzena
This World Quality Month, we reaffirm that quality is at the heart of everything we do. It defines our culture, drives our innovation, and unites our global teams. By continuing to think differently, we strengthen our commitment to delivering safe, effective, and reliable products that advance global health and improve patients’ lives, and we stay focused on moving medicines forward.
Click here to learn more about our focus on quality at Abzena.
