OSB: Single-Use vs. Stainless Steel
Definition and Benefits of Bioreactor Systems
Bioreactors are vessels used for growing cells or microorganisms in controlled environments, playing a crucial role in biopharmaceutical production. There are two primary types: stainless steel bioreactors (SSBs) and single-use bioreactors (SUBs), each with distinct advantages and limitations.
Single-Use Systems (SUS) are bioreactors designed for one-time use, eliminating the need for cleaning and sterilization between production runs (Eibl & Eibl, 2019). These systems are typically made from plastic materials such as polyethylene (PE), polystyrene, and ethylene vinyl acetate, often supplemented with additives to enhance durability and shelf life. Depending on their design, SUS can be rigid (molded systems) or flexible (multilayer film bags) and are generally supplied pre-sterilized. Common sterilization methods include gamma irradiation, autoclaving, and gas sterilization. Their ease of setup and operation allows for greater flexibility in production environments (Eibl & Eibl, 2019; Schirmer et al., 2021; Warreth, 2020).
Stainless Steel Bioreactors (SSBs) are durable, reusable systems that have been the industry standard for large-scale production. These systems are constructed from high-grade stainless steel and require rigorous cleaning and sterilization between batches. While their upfront costs are high, they provide long-term reliability and scalability, making them suitable for commercial-scale biomanufacturing.
Industry Adoption and Considerations
Single-use bioreactor systems (SUBs) are increasingly being adopted in the biopharmaceutical industry due to their ability to reduce setup time, lower cross-contamination risks, and support flexible production environments. Their ability to accelerate time to market and enhance process flexibility makes them particularly attractive for contract development and manufacturing organizations (CDMOs) and multi-product facilities (Lopes, 2013; Ruhl et al., 2013; Schirmer et al., 2021). However, concerns remain regarding their scalability and material validation.
Stainless steel bioreactors, on the other hand, remain the preferred choice for large-scale and commercial production due to their reliability, scalability, and established validation processes. While they require extensive cleaning and maintenance, they support high-volume production. (Carbungco, 2022; Page-Belknap, 2022).
Comparison of Single-Use Systems and Stainless Steel Bioreactors
| Characteristics | Single-Use Systems (SUS) | Stainless Steel Systems (SSBs) |
|---|---|---|
| Flexibility | High process flexibility, ideal for multi-product environments and R&D processes. Suitable for ATMP production, CDMOs, and CMOs (Ottinger et al., 2022; Page-Belknap, 2022; Puglia, 2024; Vogel, 2015). | Standardized, repeatable processes that ensure reliability, consistency, and durability in large-scale production (Carbungco, 2022; Page-Belknap, 2022). |
| Scalability | Typically limited in scale but allows for smaller batch sizes with rapid changeovers. | Capable of handling volumes exceeding 20,000 liters, making them ideal for commercial-scale production. |
| Environmental Impact | Reduced cleaning requirements lead to lower water (87%), space (38%), and energy consumption (30%) (Sinclair et al., 2008). Some reports indicate energy savings up to 69% (Scott, 2011). | Requires extensive cleaning (CIP/SIP) as per ASME/BPE guidelines, consuming significant purified water and energy (Page-Belknap, 2022). |
| Material Testing & Validation | Potential concerns with leachables and extractables from new polymers (Puglia, 2024). | Established validation procedures minimize contamination risks through passivation and industry-standard testing. |
Both single-use and stainless steel bioreactors have their own advantages depending on production needs. SUBs offer flexibility, reduced contamination risk, and easier changeovers, making them ideal for adaptive manufacturing environments. In contrast, SSBs provide high scalability and durability making them suitable for large-scale commercial production.
The decision between these systems should be based on factors such as process scale, regulatory compliance, operational goals, and cost considerations. A hybrid approach that integrates both technologies is also an option for manufacturers looking to optimize production efficiency.
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