A reality check on bulk drug substance cold chain operations Freezing and ultra-low temperature storage operations are becoming increasingly complex as manufacturers manage greater variability in batch sizes, multiple container formats, and growing pressure on existing facility capacity. Expanding freezer capacity alone does not solve the challenge.
This webinar challenges common assumptions in cold chain design and highlights practical approaches to reducing handling complexity, minimizing product-loss risk, and creating scalable freeze-to-store workflows for bulk drug substances.
Biologics manufacturers face growing pressure from stricter regulatory expectations, sustainability goals, and the need to scale freeze-thaw operations without compromising product quality. Traditional approaches increasingly fall short in delivering the required level of control and reproducibility.
Gain practical insights in this webinar into compliant, sustainable, and scalable freeze-thaw strategies for both bags and bottles.
Bottled Potential: Redefining bottle filling & freezing in bioprocessing
Speaker: Markus Fürhapter,Chief Technology Officer
Bottles remain a key primary packaging solution in biopharma fluid management, but when it comes to aseptic filling and freezing drug substances, they are often riddled with inefficiency and risk. Manual filling processes can lead to inefficiencies, product loss, and increased contamination risk. Meanwhile, uncontrolled freezing can compromise product integrity and stability.
In this webinar Markus Fürhapter discusses how an integrated, end-to-end fluid and cold chain process for bottles can help you harness the potential of handling drug substances in bottles.
Freezing is a critical operation in downstream processing for bulk drug substances, offering increased product stability and extended shelf life. However, challenges like cryoconcentration and protein denaturation can impact product quality. This presentation delves into experiments conducted with Single Use Support's RoSS.pFTU plate-based freezing and thawing platform, showcasing how it addresses these issues through scalable and controlled processes.
Watch the presentation to discover the science behind uniform freezing, the limitations of static methods, and the crucial role of scalability in biopharma logistics.
Temperature matters: Fluid management for cell-based applications
Speaker: Jonathan Haider,Product Line Manager Fill-Filtration Platforms
In the dynamic field of bioprocessing, maintaining precise temperature control is essential to ensuring the integrity and efficiency of fluid management systems. This webinar will explore the critical role temperature plays in optimizing bioprocesses, from preserving the stability of biological products to achieving fully closed, controlled processes.
Watch on demand as we dive into the
challenges of cell aliquotation, including cell death, homogenization, and cooling inefficiencies
solutions to implement a temperature-controlled filling process
path towards a fully automated process control of fluid management
Ensuring High Viability CHO Cells in Seed Train Intensification
Speaker: Brian Moloney & Khalil Essani, Product Line Manager
Seed train intensification is an upstream development approach to reduce manufacturing time, cost and contamination risk while increasing process consistency and yield. High cell density cultures or cell intermediates are aliquoted into single-use bags that help eliminate multiple expansion steps. However, the CHO cell viability is threatened by exposure to DMSO for a prolonged period at room temperature and uncontrolled freezing processes.
Watch this webinar on demand to learn more about the process of seed train intensification, the challenges of aliquotating and cryopreserving CHO cells, and how to achieve high cell viability and recovery.
What if your supply chain for single-use equipment was robust?
Speaker: David Seifert, Head of Sales Application Engineering (Sterile Consumables) & Khalil Essani, Product Line Manager (Sterile Consumables)
The pandemic should have taught us that dual or multi-sourcing helps to strengthen supply chains. But did you know that the implications for manufacturers and CDMOs are even greater? Watch this webinar on demand to learn more about the possibilities of using vendor-independent components for your biopharmaceutical fluid path.
Key Takeaways:
Increasing the robustness and reliability of the biopharmaceutical fluid path
Saving on supplier validation costs and time
Analyzing how pricing regulations affect market dynamics and production efficiency
What is the optimal freezing rate to enhance cell viability post-thaw?
Comparison of freezing methods and its impact on a CHO cell
What technologies can take control over ATMP freezing?
Rewatch our webinar to learn more about controlled-rate cold chain management technologies for Advanced Therapy Medicinal Products that optimize cell viability and process efficiency in different areas of biomanufacturing.
