LYOONE® a compact pilot-scale freeze dryer for HPAPI
LYO ONE® enables you to safely and efficiently develop high‑value ADC products in a controlled lab environment by combining robust containment with straightforward operation and maintenance. Key features include ease of cleaning, standardized product design, and a close collaboration with the isolator supplier.
GEA.com
LYO ONE® A COMPACT PILOT SCALE FREEZE DRYER FOR HPAPI*.
A future-ready solution to meet growing industry demand for antibody-drug conjugate (ADC) processing.
LYO ONE® enables you to safely and efficiently develop high‑value ADC products in a controlled lab environment by combining robust containment with straightforward operation and maintenance.
Key features include ease of cleaning, standardized product design, and a close collaboration with the isolator supplier.
* 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.
The ADC sector is burgeoning. First approved by the US FDA in 2000, antibody drug conjugates combine the high target specificity of an antibody with a highly toxic
active pharmaceutical ingredient (API). Designed to seek out and destroy cancer cells without harming the rest of the host organism, these products are sensitive, labile, and have an extremely short shelf- life. In short, they need to be stabilized by lyophilization.
“The market value of ADCs is escalating,” says Thomas Beutler, Senior Director, Lyophilization Technology Management, adding: “Innovator companies are developing drugs that exceed the capabilities of existing equipment. This is where GEA steps in. Drawing on decades of experience in aseptic processing and containment, GEA is helping pharmaceutical companies
worldwide to rethink every stage of highly potent processing.”
He concludes: “The lab-scale LYO ONE® freeze dryer was conceived, optimized and built to support the industry’s requirement to dry highly toxic, highly potent ADC APIs and linkers.”
MEETING MARKET DEMAND. GEA has introduced the pilot-scale LYO ONE® freeze dryer to address the growing demand for advanced solutions in the development of highly toxic compounds, including antibody-drug conjugates (ADCs).
2 LYO ONE Compact Pilot Scale Freeze Dryer.
Offering robust performance and enhanced safety for complex pharmaceutical processes, the LYO ONE® is a cutting-edge system designed to support both laboratory and production-scale applications.
With its unique integration into the isolator’s rear wall, the LYO ONE® combines innovation and safety by allowing full access for cleaning and verification while enhancing containment.
Now available as a research-level version that can accommodate four GORE® LYOGUARD® Freeze-Drying Trays, the lab-scale LYO ONE® is a standardized yet versatile, high-performance solution for the pharmaceutical and biotechnology sectors.
Its compact, space‑saving design fits into a standard isolator footprint. The combined HMI for the isolator and the freeze dryer ensures a consistent look and feel, making the machine easy to handle and operate.
Future plans include the development of a larger, pilot-scale unit that can handle up to 90 LYOGUARD® trays.
THE SOLUTION YOU NEED.
The LYO ONE® is a pilot‑scale, isolator‑integrated freeze dryer designed specifically for ADC development and other highly toxic, highly potent APIs.
3 LYO ONE Compact Pilot Scale Freeze Dryer.
Technical Details • �Four product shelves: 400 x 270mm (temperature range = –60 to +60 °C) • �Fluid ice condenser temperature (<–75 °C | 8 kg capacity) • �Oil-sealed vacuum pump • �Vacuum control from 0.005–1.000 mbar • �Vacuum pressure measurement (chamber: MKS + Pirani | Condenser: MKS) • �Linear drive for 5V1 with bellows • �Cleaning concept through the isolator
The machine also features a vacuum-based extraction mechanism and changeable toxic filters for the vacuum pumps inside the isolator.
Designed with cleanability in mind, the lab- scale LYO ONE® features an evaporator with coil-free Buko plates, a static shelf package and easy access to all critical areas (chamber and condenser) through swing doors that open fully.
The absence of a hydraulic cylinder and the ability to use WIP spray guns within the isolator facilitate the washdown process and minimize both downtime and the amount of wash media required (a significant advantage compared with traditional clean- in-place solutions).
For cost-efficiency, a key criterion during the design process was that the LYO ONE® should fit inside a standard-size isolator. The modest footprint, optimized door design and compatibility with existing plant ensure both initial and long-term value for money.
OWNER AND OPERATOR BENEFITS. Operation is simple and intuitive: the single HMI supports safe manual loading and handling via glove ports.
Further information Joerg Kuepper Area Sales Manager joerg.kuepper@gea.com gea.com/contact
4 LYO ONE Compact Pilot Scale Freeze Dryer.
https://www.youtube.com/GEAPharma https://www.linkedin.com/showcase/gea-pharma-&-healthcare/ https://www.facebook.com/GEAPharma
GEA.com
© GEA Lyophil GmbH 2026. All rights reserved. Subject to modifications. LYO ONE®, GORE® & LYOGUARD® are registered as trademarks in several countries worldwide.
GEA Lyophil GmbH Siemensstrasse 9, 50189 Elsdorf, Germany
Tel +49 2274 93 80 99-0 lyophil@gea.com gea.com/contact