Engineered for critical biopharmaceutical processing, the CryoXpert Cryogenic Pelletizer transforms high-value liquids, including cell cultures, viral vectors, gene therapy materials, and biological APIs, into sterile frozen pearls. Featuring a fully CIP/SIP-compatible design, the system can be automatically steam-sterilized to support aseptic manufacturing standards. Direct liquid nitrogen droplet freezing preserves delicate tertiary protein structures and cell viability for reliable downstream processing and storage.
R&D/Pilot to continuous production scale
The CryoXpert Lab Pelletizer is a specialized laboratory system developed by CryoXpert, Dohmeyer’s medical and pharmaceutical division, specifically for R&D, clinical trial formulations, and small-batch production of sensitive biopharmaceuticals. Designed for high-value biological products, the system features a precision peristaltic dosing pump paired with interchangeable dripping nozzles (such as 1.0 mm, 2.0 mm, and 2.8mm orifice diameters) to accommodate varying product viscosities. Liquid formulations including cell therapy materials, gene therapy vectors, viral vectors, diagnostic enzymes, and live biotherapeutic products, are metered into a bath of liquid nitrogen.
Instant contact freezing solidifies each droplet into a spherical pearl, reaching temperatures below -40°C within seconds and yielding a uniform pellet size distribution between 3 mm and 5 mm. This ultra-fast cooling protects delicate tertiary and quaternary protein structures, prevents ice crystal growth, and maintains cell viability without satellite droplet formation.
The compact, small-footprint unit minimizes liquid nitrogen consumption per batch, making it ideal for laboratory fume hoods and cleanroom environments. Engineered under cGMP guidelines and ISO13485 standards, the Lab CryoXpert Pelletizer incorporates 21 CFR Part 11compliant digital controls that record process parameters and generate encrypted PDF audit reports to ensure complete data integrity for regulatory submission.
Engineered for clinical trial manufacturing and campaign-based biopharmaceutical production, the CryoXpert Batch Pelletizer processes up to 50 kg per batch under validated, sterile conditions. Utilizing customized dripping manifolds tuned to specific fluid rheologies, the unit dispenses biological suspensions, such as active pharmaceutical ingredients(APIs), therapeutic proteins, starter cultures, and bulk vaccine intermediaries, directly into a liquid nitrogen immersion bath.
To maintain an uncompromised cold chain and ensure uniform freezing, controlled gaseous nitrogen injection creates an internal liquid circulation that regulates pellet residence time. Solidified cryo-pellets sink into a bottom-mounted retrieval basket inside the enclosed vessel.
Harvesting is conducted via an overhead lifting crane or a pivoting vessel rotation mechanism that discharges frozen pearls directly into sterile collection containers or reactors without ambient exposure. The system operates under strict cGMP guidelines and ISO 13485 certified quality management. Integrated PLC/HMI controls support 21 CFR Part 11 compliance with user RFID access and automated encrypted data reporting, while an optional redundant safety loop and UPS backup safeguard high-value biological batches against power disruptions or sensor errors.
For continuous commercial manufacturing of pharmaceuticals, diagnostic reagents, and industrial enzymes, the CryoXpert Continuous Pelletizer provides high-throughput processing from 50 kg up to 850kg per hour. Biopharmaceutical liquid feeds are metered continuously across multi-nozzle arrays into a liquid nitrogen trough, where instant flash-freezing solidifies droplets into spherical pearls before an internal heavy-duty SS316 stainless steel mesh conveyor continuously extracts them from the cryogen bath.
The machine features an integrated exhaust fan system that safely evacuates excess nitrogen gas from the aseptic workspace. To meet biopharmaceutical sterility requirements, the unit incorporates an automated Clean-In-Place (CIP) system with SS316 rigid piping and multi-circuit spray headers. The entire system is managed via a HMI touch visualization interface running Dohmeyer software configured for 21 CFR Part 11 compliance, autogenerating encrypted PDF batch reports and preserving biological activity for large-scale lyophilization or direct sterile packaging.
The modern processing landscape requires equipment capable of adapting to diverse product portfolios, from biopharma suspensions to viral vectors and mRNA-lipid nanoparticle (LNP) formulations. The Dohmeyer Cryo Pelletizers deliver exceptional flexibility through its modular architecture and precise control systems. The precision dosing module can be finely adjusted to handle liquids with varying densities, including bacteria cultures, proteins, and a whole range of pharmaceutical substances, guaranteeing accurate droplet formation across different recipes. Because the system is engineered for scalability, manufacturers can initially deploy the unit for small-batch clinical trials, and efficiently scale up to continuous, full-scale manufacturing without altering the core freezing dynamics, ensuring complete product consistency at any capacity.
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