Redefining Cost-Efficiency in Sterile Oncology Manufacturing Under EU GMP Annex 1

Presented by Rodrigo Rial – Business Manager, VIVUNT Oncology

Sterile oncology drug manufacturing operates at the crossroads of scientific precision and life-critical patient care. These therapies often involve highly potent active ingredients, requiring exceptional containment and meticulous aseptic handling. The updated Annex 1 of the EU GMP has raised the bar even higher, demanding enhanced contamination control and stricter environmental monitoring—deepening the complexity of an already exacting field.

Despite these challenges, leading manufacturers are proving that substantial cost reductions are achievable by investing in intelligent facility design, lean operations, and modern technologies—all while maintaining the highest standards of quality and compliance.

A foundational driver behind this success is a development approach that prioritizes early risk assessment and deep process insight. By identifying critical parameters from the outset—those most likely to impact cost and product quality—manufacturers can front-load process knowledge through structured experimentation and robust risk evaluations. This proactive strategy minimizes late-stage surprises and accelerates regulatory alignment under Annex 1. In a high-stakes environment where every batch carries immense value, avoiding rework and deviations is a key lever for cost efficiency.

At the heart of sterility assurance, advanced aseptic technologies are proving indispensable. A notable shift has been the widespread adoption of isolator-based systems, particularly for filling and capping processes. By enclosing these critical steps within sealed, monitored environments, isolators drastically reduce human intervention—a major source of contamination risk. Though initial investments are higher, isolators yield long-term savings by reducing HVAC load, gowning requirements, and the need for expansive Grade A/B space.

Automation has also delivered major gains. Visual inspection systems for vials and syringes now routinely outperform manual checks, halving error rates, reducing labor costs by 20%, and enhancing compliance with Annex 1’s intensified monitoring mandates.

In tandem, lean manufacturing principles continue to drive efficiency. By eliminating waste—whether it’s excessive waiting, redundant steps, or bloated inventory—companies shorten lead times, trim labor costs, and reduce defect rates. When these practices are integrated with digital tools like predictive analytics and electronic batch records, the benefits multiply. Real-time process insights enable early problem detection and optimized maintenance schedules, boosting uptime and ensuring precise documentation for regulatory readiness.

Supply chain agility is another essential piece of the puzzle. Ensuring timely access to high- quality raw materials is critical to preventing costly delays, especially given the sensitive nature of oncology APIs. Just-in-time delivery, vendor-managed inventory, and dual- sourcing strategies help mitigate risk while containing holding costs.

Vivunt Oncology exemplifies how these elements come together. As a CDMO specializing in sterile oncology manufacturing, Vivunt has implemented a strategically engineered aseptic facility aligned with Annex 1 standards. Equipped with state-of-the-art isolator lines and automation, and guided by risk-based process design, the facility delivers both regulatory robustness and economic efficiency.

We don’t just build capacity—we build strategic partnerships. Whether supporting early-stage clinical fills or scaling commercial production, Vivunt offers pharma and biotech companies a forward-looking CDMO model built around compliance, agility, and performance.

Success in this space demands a holistic vision—one that integrates thoughtful development, technological advancement, operational discipline, and strong supplier partnerships. With a culture of continuous improvement, companies can dramatically lower the cost of sterile oncology drug production while enhancing patient safety and meeting the demands of modern regulatory frameworks. The reward: fewer failures, greater efficiency, and improved global access to life-saving therapies.