Discover the Ultimate One-Step Method to Perfectly Cultivate Prokaryotic Cells ! Revolutionize Your Cell Cultivation Experience!
February 6th 2024

The global biopharmaceutical market is experiencing steady growth, fueled by advancements in biotechnology, continuous global population expansion, an aging demographic, and numerous unmet medical needs. However, the complexity of bioproducts, especially gene and cell therapy products, presents challenges such as their diverse nature, high sensitivity, lengthy production processes, complex manufacturing requirements, and various raw material types. These factors underscore the importance of stringent aseptic risk control during the production process, making single-use technology a crucial asset in mitigating such risks.

At the end of 2022, ReportLinker published a report titled Global Single-Use Bioprocessing Market, which underscored the prevailing use of stainless-steel tank production processes in commercial biopharmaceutical manufacturing. due to their economic feasibility. However, concurrent with evolving regulatory requirements, demand for production flexibility, risk reduction in cross-contamination (particularly in smaller-scale commercial stages), enhanced production efficiency, and reduced investment costs, single-use bioprocessing systems have surged in popularity. They now dominate the pre-commercialization market for biophåarmaceutical production and are gradually expanding their footprint in commercial production.

The Benefits of One-Step Disposal  

The initial iteration of disposable production processes, labeled as Version 1.0, predominantly focused on disposable upstream fermentation techniques. This methodology frequently employed disposable bags for Escherichia coli fermentation, particularly in plasmid production. Nonetheless, the landscape has since evolved significantly. Innovations in both upstream and downstream supply chains, alongside the embrace of the Quality by Design (QbD) framework, have catalyzed the emergence of a novel approach: the one-step disposable process for prokaryotic cell culture, specifically tailored for plasmid production.

This innovative approach ensures complete aseptic control throughout the entire process, with all steps — from inoculation to fermentation, cell harvesting, lysis, clarification filtration, ultrafiltration, and chromatography — conducted in a fully enclosed manner. It addresses the challenges of aseptic control in producing viral vector plasmids, naked plasmids, and bacterial preparations. Moreover, employing disposable consumables eliminates the risk of cross-contamination between different products, obviating the need for residual testing during product changeover. Consequently, this simplifies cleaning process development and alleviates challenges related to regulatory compliance regarding residual testing specificity and sensitivity, maximizing cross-contamination risk mitigation. 

Challenges of the one-step disposable process for prokaryotic cell culture (plasmid) production

Despite its advantages, the one-step disposable process presents challenges compared to highly automated stainless-steel systems, particularly in terms of process complexity and manual intervention requirements. Challenges include:

  • Process Complexity: The production process involves multiple steps, including inoculation, fermentation, harvesting, lysis, clarification filtration, ultrafiltration, chromatography, etc. Each step requires precise control and optimization to ensure product quality and yield.
  • Control of Cell Culture Conditions: Strict control of parameters such as temperature, pH, oxygen content, nutrient concentrations, etc., is crucial for promoting cell growth and expression of the target product during prokaryotic cell culture.
  • Selection and Maintenance of Strains: Proper selection of bacterial strains is essential for the success of the production process. Effective preservation and maintenance of strains are also necessary to ensure their stability and viability.
  • Aseptic Control of Production Processes: While disposable processes can reduce the risk of cross-contamination, strict aseptic operation control is still required to ensure product purity and safety.
  • Stability of Plasmid Construction and Expression: The stability of plasmid construction and expression directly impacts the quality and yield of the final product, requiring careful design and optimization.
  • Product Purification and Refinement: Multiple purification and refinement steps, including lysis, clarification filtration, ultrafiltration, chromatography, etc., are necessary during the production process. Each step needs to effectively remove impurities and improve the purity of the target product.

Maintaining Quality and Quantity - Comparable Yield to Stainless-Steel Systems

With over 20 batches of disposable GMP plasmid production experience, OBiO Tech has demonstrated that the yield of disposable process systems matches that of stainless-steel systems, as shown in Figure 1. 

Figure 1: Comparison of Plasmid Yield from Escherichia coli Fermentation

Apart from the performance of cultivation, another important factor affecting production capacity is turnover rate. Due to the faster turnover rate of disposable process systems, the capacity of this platform is double that of stainless-steel fermentation tanks. The one-step disposable process for a prokaryotic cell culture (plasmid) production system can produce 135 batches per year, while stainless-steel systems can produce 67 batches per year.

A comprehensive and flexible platform for prokaryotic cell culture (plasmid) production

Located within a sprawling 77,000-square-meter Lingang Industrial site, OBiO Tech's facility stands as a cornerstone in the precision medical industry. It boasts three distinct production lines tailored for commercial GMP production of prokaryotic cell culture (plasmid), including: a cutting-edge, one-step disposable process production line, a versatile 10L-50L-500L bioreactor production line, and a reliable stainless-steel system production line.

Guided by the principles of QbD and BSL-2, OBiO Tech's CDMO platform offers rapid, tailored solutions for various plasmid products and bacterial preparations, catering to diverse production requirements. Whether it’s plasmids for viral vector production, naked plasmids, or bacterial preparations, OBiO Tech's platform provides a spectrum of equipment with varying capacities and flexible facility configurations, ensuring adaptability to unique needs.

Distinguished by its meticulous design, the platform delineates between areas for live organisms and non-live organisms, with meticulously planned flows for personnel, materials, and waste. This segregation not only enhances biosafety but also accelerates product transformation speed, exemplifying our commitment to efficiency and excellence in biopharmaceutical production.

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