July 14, 2025
As anticancer drugs become more powerful and complex, GEA is redefining how to safely freeze-dry these life-saving treatments.
A new wave of oncology treatments is changing the face of cancer care. Among the most promising innovations are antibody-drug conjugates (ADCs) – targeted therapies that combine the specificity of antibodies with the potency of cytotoxic drugs. Their strength lies in precision: delivering powerful drugs directly to cancer cells while minimizing damage to healthy tissue.
But as pharmaceutical innovation accelerates, so, too, do the manufacturing challenges. ADCs are not only more effective – they’re also more toxic, sensitive and unstable than traditional chemotherapy agents. To ensure these advanced therapies are both safe and effective for patients, manufacturers must reimagine how they are produced, handled and stabilized.
Freeze drying, or lyophilization, is essential for extending the shelf life of ADCs. Without it, these sensitive compounds degrade rapidly. Yet, while this technique has long been used in pharmaceutical manufacturing, 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.
Antibody-drug conjugates are targeted therapies that combine the specificity of antibodies with the potency of cytotoxic drugs.
This is where GEA steps in. Drawing on decades of experience in aseptic processing and containment, GEA is helping pharmaceutical companies rethink every stage of ADC production. 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.
GEA’s newest innovation, LYOONE, has been developed in direct response to the industry’s evolving needs. Based on extensive customer feedback, LYOONE combines previously separate safety and process enhancements into a single, comprehensive freeze-drying solution. It reflects the specific demand for a future-ready platform that can manage the increasing potency and complexity of oncology drugs.
“It’s a very new kind of application and GEA has position itself as a first mover here,” says Jörg Küpper, Sales Manager at GEA. “Working with ADCs obligates the manufacturer to lyophilize the product. They’re sensitive, labile and, unless stabilized by freeze drying, they have an extremely short shelf life.”
LYOONE combines previously separate safety and process enhancements into a single, comprehensive freeze-drying solution.
Containment is key. Exposure to even trace amounts of ADC powder 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 like 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, another for non-toxic fluids – ensuring 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. In ADC manufacturing, that’s not just a nuisance – it’s a safety risk.
“Just thinking about line clearance,” adds Küpper. “You might look inside the freeze dryer and spot a fallen vial or a rogue cake. This, in the past, might not be a significant issue. Now, with an ADC, it poses a problem. You need to ensure that there is no powder anywhere. It needs to be bound in a liquid so that it doesn’t get airborne.”
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.
Importantly, GEA supports customers from start to finish. Freeze-drying ADCs isn’t just about equipment – it’s about building a comprehensive strategy. This includes evaluating occupational exposure limits (OELs), designing around acceptable daily intake (ADI) thresholds, and configuring systems based on the scale and complexity of production.
“When you formulate an ADC and it’s in liquid form (in a solvent), it’s not overly dangerous,” explains Dr. Benjamin Ledermann, a biochemist from GEA. “The problem arises when it becomes a powder and has the potential to create an aerosol. ADCs suddenly become very hazardous when you start drying them – or they dry out in an unplanned situation.”
Ultimately, the goal is clear: ensure that every ADC product maintains its structure, remains sterile and is safe to administer. If the delicate linker between the antibody and drug payload breaks down, the therapeutic benefit is lost – and the risk of toxicity increases. Freeze-drying must preserve that structure while preventing contamination at each stage.
As the pharmaceutical industry continues to explore the full potential of ADCs – for cancer and beyond – pharma engineers at GEA are proud to be at the forefront. With a track record of innovation, a deep understanding of containment and a customer-centric approach, GEA is enabling manufacturers to bring these groundbreaking therapies to market safely, efficiently and responsibly.