Quality and Innovation at the Forefront

At Astrea Bioseparations, ensuring quality is at the core of everything we do. We strive to be the supplier of choice for customer-focused, innovative bio-chromatography products and services. We are dedicated to upholding the highest standards across all aspects of our operations, with a constant and measurable commitment to enhancing QA practices. Our culture of continuous improvement is actively fostered by senior management and supported by clearly defined objectives and meticulous procedures, verifying that every facet of our operations exemplifies our unwavering commitment to our customers.

Maintaining Momentum in Our Quality Improvement Initiatives

Since 2016, we have taken several initiatives to enhance our quality systems:

• A detailed review of our deviation and change control systems
• Ongoing evaluation of root cause analysis and risk management
• Implemented a dedicated Technology Transfer department to support process and analytical validation

These developments and ongoing efforts reflect our dedication to preserving the highest standards of quality and guaranteeing that our products and services consistently meet the critical performance requirements necessary for the manufacture of biopharmaceuticals.

Upholding Quality with ISO 9001:2015 Certification

We at Astrea Bioseparations adhere to the ISO 9001:2015 standard as a foundational requirement for all our quality management activities. A significant step in our recent efforts includes the integration of our sites in Cambridge, UK, the Isle of Man, and most recently, Boston, into a unified and easy-to-use quality management system (QMS). This integration, with the addition of new sites, has not only been successfully audited but is now a recognized part of our ISO 9001:2015 certification. By expanding our QMS to include these sites, we have scaled our quality assurance capabilities efficiently, without the need for a corresponding increase in QA staff. This ensures that all our customers receive the same high-quality service and products, regardless of the site of supply.

Sustaining Progress: Our Ongoing Journey in Quality and Innovation

Our team here at Astrea Bioseparations are dedicated to continuous improvement and innovation. We aim to not only meet but exceed the expectations of our clients by providing high-quality, reliable products and services that are integral to the success of biopharmaceutical manufacturing. As we move forward, our focus remains on expanding our capabilities and enhancing the trust placed in us by our clients worldwide.