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MedTech Outlook | Wednesday, May 03, 2023
Modern single-use systems offer numerous advantages, including transferring liquids across manifolds quickly and precisely.
FREMONT, CA:Fluid management in biopharma has seen a significant change recently. Biopharmaceutical businesses' manufacturing and supply chain divisions are undergoing a significant paradigm shift due to the developments in life science and the corresponding changes in healthcare.
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Since the supply chains for cutting-edge therapies like gene and cell therapies (CGT) frequently start and end at the patient rather than the distribution network in traditional pharma, these therapies call for fundamentally different drug manufacturing methods. These business concepts are difficult to scale up when they are made more widely available. Partnerships with businesses that provide scalable solutions to their process obstacles are helping the sector.
Single-use equipment:Since the vast majority of stages in the manufacturing departments of biotech businesses involve liquids, such as feed media, buffer solutions, cell extracts, and product fractions, these departments are heavily invested in fluid control systems. Process engineers distinguish between "greenfield" needs for fluid management, or those with no stringent limits in the process setup, and "established plant floors," or those with boundary conditions in the process architecture defined by existing equipment. In the latter scenario, more flexibility is made possible by single-use equipment. For instance, a facility that makes seasonal vaccinations must frequently set up new procedures. Single-use systems can benefit from their major advantages at such facilities with many manufacturing campaigns: no cross-contamination hazards and no requirement for cleaning or sterilization procedures along the fluid route.The flow diagrams for the liquids involved, their flow volumes, and the daily and long-term storage requirements can all be determined using process simulations. Considering the materials used in the fluid transfer process is another crucial factor since they must possess the necessary mechanical and chemical characteristics, such as flexibility, toughness, and solvent compatibility, to reduce the danger of leakage. They also need to be compliant with regulations and biocompatible. Since they satisfy both requirements, silicone, TPE, and PTFE are frequently used to make single-use equipment.
Good manufacturing practices: Liquid control systems face difficulties in biopharmaceutical manufacturing processes beyond simply fulfilling logistical process needs. The stringent requirements of regulatory authorities must be met to guarantee the security of biopharmaceutical products. A significant component of current good manufacturing practice (cGMP) is that biomanufacturing operations are typically carried out under sterile or aseptic settings to attain bioburden levels that adhere to the appropriate criteria. Before any contact with process liquids, traditional processes utilizing stainless steel pipes require cleaning and sterilization techniques (such as cleaning and sterilizing in place) and the corresponding validation. Naturally, this impacts cost-effectiveness and scalability because resources (labor, time, and plant footprint) are tied to these phases.The analysis of the bioprocessing workflow demonstrates that switching to single-use solutions provides sufficient resources to outperform the potentially reduced purchase cost of multi-use equipment throughout the campaign and enable higher productivity and efficiency. For most process steps regularly carried out by biopharmaceutical industry facilities, single-use components are available.
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