Efficient bulk drug substance freezing & ULT storage

Existing facilities, new demands: Optimizing cold chain biomanufacturing capacity in brownfield sites

Biopharmaceutical manufacturing has undergone a shift toward higher production volumes, more diversified modalities, and more flexible production models. Despite these new demands for handling varying batch sizes and customer-specific requirements, expectations placed on CDMOs for new programs continue to rise. However, many of these operations still rely on brownfield facilities; sites that were not originally designed to accomodate today's level of variability in bioprocessing and hence limited biomanufacturing capacity. Expanding infrastructure is often not an option. Instead, teams are increasingly challenged to optimize existing workflows within fixed spatial and technical constraints.  So, how is it possible to increase biomanufacturing capacity without expanding their facility footprint?   What are brownfield and greenfield facilities in biopharma manufacturing? Brownfield facilities are existing production environments with fixed and already existing layouts, utilities, and equipment footprints. As processes evolve, these constraints limit flexibility and make operational adjustments more complex.  Greenfield facilities are designed from the ground up, allowing equipment, material flow, and process steps to be aligned from the beginning. This enables more efficient and scalable workflows.  Both facility types face the same pressure: increasing volumes and cost constraints make space-efficient freezing and storage essential. However, greenfield sites can plan for these equipments, while brownfield facilities must optimize within existing limitations.    Why are freezing and storage critical bottlenecks? CDMOs are dealing with increasing process complexity and variability in cold chain management due to the fact that: Single-use bioprocess container formats vary Batch sizes fluctuate Regulatory expectations continue to increase Sustainability plays a larger role There are purpose-built freezers used during drug substance production: while freezing drug substances in different bioprocess containers formats is about controlled heat transfer from ambient temperature down to -80°C (or colder), ultra-low temperature storage focuses on mid-to-long term temperature stability and consistency for cryopreservation.  Freezing and storage are closely linked but often not designed as a continuous system. This mismatch becomes particularly visible in constrained (brownfield) environments.  When freezing capacity does not align with storage capacity, materials are transferred between incompatible systems. This is why frozen batches are often split or handled together with other batches that perhaps would require other storage specifications. As a result, storage is often expanded incrementally by just adding new systems, without improving overall efficiency. And in most cases facility space is limited.  Cold chain compliance for drug substances   How can CDMOs increase biomanufacturing capacity without expanding facility space? In many cases, physical expansion is simply not feasible. Therefore, the question is more about how to increase usable capacity within the existing footprint. This shifts the focus from infrastructure to workflow design. Instead of adding more equipment, the goal is to make better use of available space by reducing inefficiencies between process steps.  One key concept that emerges in this context is full-batch handling. Rather than managing multiple partial batches across different systems, the entire drug substance batch remains in a consistent format throughout freezing and storage.  This approach reduces intervention points and allows processes to run more predictably, even in constrained environments.      How does harmonizing freezing and storage improve process efficiency? Too often, freezing and storage operations are treated in isolation despite being operationally interdependent. To be fair, there has been a lack of such compatible systems for freezing and storage available too. The result is unnecessary product handling, process interruptions, and increased operational complexity.  Harmonization improves efficiency in brownfield facilities and addresses this disconnect by aligning system capacities, chamber geometries, and operational workflows. When both steps are built around identical batch formats, processes become more predictable, transitions more seamless, and manual interventions are minimized.  Single Use Support's RoSS.BLST and RoSS.ULTF systems translate this principle into practice. While serving different purposes - controlled blast freezing and thawing on the one hand, and ultra-low temperature storage on the other, both systems feature fully compatible chamber dimensions. As a result, entire batches can be transferred directly from freezing to storage without repacking, preserving process integrity while significantly simplifying operations.  Efficiency gains extend beyond workflow optimization to facility layout and space utilization. With best-in-class usable chamber volume per footprint, RoSS.BLST enables high-capacity blast freezing within a minimal footprint - a critical advantage in space-constrained brownfield environments.    [[download-1-email-detailed]]   What does that mean for process engineers and MSAT teams?  Harmonized freezing and storage systems support a consistent, streamlined process that reduces handling, optimizes space utilization, and increases overall throughput.  Complementary systems that work together as one process help considerably to reduce the number of handling steps, aligning process capacities, and standardizing batch formats. All of these improvements can have a measurable impact on both performance and efficiency.  Equally important, these changes support compliance and documentation. When full batches are processed consistently across steps, traceability improves, and validation efforts become more straightforward.    RoSS.BLST RoSS.BLST is a controlled blast freezing & thawing system for drug substances. It is suitable for any primary packaging from all manufacturers and allows freezing and thawing down to -80°C. Its modular and mobile internal rack system offers maximal flexibility and enables a simple transfer from blast freezing to ultra-cold storage. RoSS.ULTF RoSS.ULTF is an upright ultra-low temperature storage freezer for frozen drug substances in different batch sizes. The ultra cold storage freezer maintains the desired set point temperature down to -80°C.