RoSS.pFTU: Scalable Freezing And Thawing For Process Development And Manufacturing
RoSS.pFTU is a plate-based freeze-thaw platform designed for controlled, scalable freezing and thawing of biopharmaceutical drug substances. Compatible with single-use bags and bottles from multiple suppliers, the platform supports a vendor-independent freeze/thaw strategy from process development through commercial manufacturing.
By combining controlled ice front growth with reproducible process parameters, RoSS.pFTU helps maintain product consistency across scales while reducing variability between batches. The platform supports both freezing and thawing applications and enables the development of scalable freeze/thaw recipes for a wide range of biologics, including monoclonal antibodies, recombinant proteins, and advanced therapy medicinal products (ATMPs).
RoSS.pFTU Product Family
- RoSS.pFTU Benchtop for early process development, formulation screening, and freeze/thaw characterization studies at small volumes.
- RoSS.pFTU Lab Scale for process development, clinical manufacturing, and cell & gene therapy applications.
- RoSS.pFTU Mid Scale for pilot and early commercial operations with batch volumes up to 100 L.
- RoSS.pFTU Large Scale for commercial bulk drug substance manufacturing with batch volumes up to 400 L.
- RoSS.pFTU XL for large-scale bulk drug substance freezing and thawing, supporting higher throughput and storage demands in commercial manufacturing environments.
Key Benefits
- Vendor-independent platform for 2D single-use bags from multiple manufacturers
- Scalable freeze/thaw recipes from development to commercial manufacturing
- Controlled ice front growth for reproducible freezing conditions across scales
- Protection of primary packaging through dedicated RoSS® shell systems
- Support for batch volumes with up to 50 L single-use bags
- Automated and GMP-compliant operation
- Freeze temperatures down to -80°C
- Designed to support process consistency, product quality, and operational efficiency