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THE FUTURE- READY FREEZE- DRYER FOR HIGHLY POTENT APPLICATIONS. Tailored to meet the specific challenges of handling anticancer drugs, GEA’s next-generation lyophilization technology sets new standards of safety and efficiency.

With an increasing emphasis on both operator safety and product protection, manufacturing oncology drugs, hormonal products and/or other highly potent compounds has been put under the pharmaceutical spotlight in recent years. Among the most promising innovations in anti- cancer therapy, for example, are antibody-drug conjugates (ADCs). These targeted therapies combine the specificity of antibodies with the potency of cytotoxic drugs to deliver potent actives directly to cancer cells while minimizing damage to healthy tissue.

Freeze drying or lyophilization is essential when it comes to extending the shelf-life of potent compounds and preventing degradation. And although this technique has a long history

of use in pharmaceutical manufacturing, drugs such as ADCs introduce a new level of complexity. Once freeze- dried, these potent molecules become hazardous if even microscopic particles become airborne. What was once a standard process is now fraught with risk.

This is where GEA steps in. Drawing on decades of experience in aseptic processing and containment, GEA is helping pharmaceutical companies to rethink every stage of highly potent processing. From risk assessments and system design to cleaning protocols and environmental safety, GEA offers fully integrated solutions that prioritize both product integrity and operator protection.

Based on extensive customer feedback, GEA’s latest innovation for pharmaceutical freeze-drying applications has been developed in direct response to the industry’s evolving needs.

The LYO ONE® freeze dryer meets the growing demand for a future-ready platform that can handle the increasing potency and complexity of highly potent compounds.

Featuring a safety-focused design, the freeze dryer and condenser chamber have been integrated into the rear wall of the isolator. Each is accessible via separate entry points to ensure optimal accessibility for cleaning and visual inspection.

Likewise, the specially engineered condenser plates facilitate both cleaning and inspection. In addition, the vacuum line has been reconfigured to use the isolator’s HEPA filtration system for better particle retention.

Available in two configurations, the research and small- scale development version can accommodate three GORE® LYOGUARD® freeze-drying trays, whereas the machine designed for commercial-level production can fit 32 of these fully enclosed, single-use containers. This scalability makes LYO ONE® an ideal choice for pharma and biotech companies aiming to accelerate the transition from R&D to large-scale production.

The Future-Ready Freeze-Dryer for Highly Potent Applications.

Introducing LYO ONE®.

2 The Future-Ready Freeze-Dryer for Highly Potent Applications.

For further information GEA Pharma & Healthcare pharma@gea.com gea.com/contact

Exposure to even trace amounts of highly potent active pharmaceutical ingredients (HPAPIs) can pose serious health risks. That’s why GEA places a strong focus on preventing airborne contamination — whether from damaged vials, dried residues, or hidden crevices in the equipment.

This means developing systems with minimal dirt corners, easy-to-access components, and validated clean-in-place (CIP) procedures that reduce water usage and manage toxic wastewater effectively.

Even components such as vacuum pumps need special attention. To protect them from contamination, filters must be installed, cleaned, and maintained in a way that isolates any toxic particles.

In some cases, dual drainage systems are required — one for toxic discharge and another for non-toxic fluids — to ensure that no harmful material enters the environment.

GEA also addresses line clearance, one of the most overlooked yet critical phases of production. A single fallen vial or unbound powder residue could result in significant operator exposure.

Another essential factor is the design of the loading and unloading systems. During the initial liquid phase, ADCs are less hazardous. But as soon as drying begins — or if an unexpected spill occurs — the risk escalates. GEA’s technologies are engineered to reduce the chance of contamination at these transition points, keeping both product and people safe.

Containment is Key.

3 The Future-Ready Freeze-Dryer for Highly Potent Applications.

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© GEA Lyophil GmbH 2025. All rights reserved. Subject to modifications. LYO ONE®, GORE® & LYOGUARD® are registered as trademarks in several countries worldwide.

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