Bioreactors

Updating the Economics of Biologics Manufacturing with 5,000-L Single-Use Bioreactors: A Paradigm Shift

Single-use technologies enable a flexibility and modularity effectively unattainable with more traditional stainless-steel technologies, particularly in upstream bioprocesses. Single-use bioreactors up to 2,000 L are employed largely in preclinical- and clinical-stage bioprocesses to leverage this flexibility. As products reach commercial maturity, scales larger than 2,000 L frequently become desirable to take advantage of economies of scale. With the typical upper limit of single-use bioreactors at 2,000 L, this has traditionally meant transfer to stainless-steel systems. The introduction of the Thermo…

Dissolved Oxygen Control Tuning for Cell Culture Applications

Proper tuning of dissolved oxygen (DO) controller proportional integral (PI) values is essential for optimal cell culture performance in a bioreactor. When DO-PI values are optimized, gas flows are smoothed, and foaming and cell stress are reduced. Traditionally, this tuning has been performed by using nitrogen gas to purge oxygen from a test solution, thus simulating oxygen demand. That method has several drawbacks, however. First, nitrogen gassing cannot simulate the high demands of high-density fermentation. Second, nitrogen competes with other…

Retrofitting Your Bioreactor to Enhance Stirring Processes: Replacing Old Agitators with State-of-the-Art Magnetic Mixing Technology

A key challenge for companies involved in drug development is to meet the highest standards of sterile design and reliability. In this context, magnetic mixers offers many advantages for aseptic stirring processes compared to mechanically sealed agitators. ZETA not only supplies magnetic agitators for new bioreactors, but also supports its customers through the entire retrofitting process, from feasibility studies at the beginning to full process qualification and validation at the end. “Combat the risk of batch contamination in bioreactors and…

A Rapid, Low-Risk Approach Process Transfer of Biologics from Development to Manufacturing Scale

Successful scale-up of cell culture for manufacturing of biopharmaceuticals gives companies time to accelerate clinical development, product commercialization, and market access (1). Scaling a cell culture process in stirred-tank bioreactors ideally includes optimizing that process at laboratory scale and then transferring it through larger pilot-scale and finally to manufacturing-scale bioreactors (2). This is a complex, time-consuming business that can involve process transfer — sometimes to different geographical locations and through many sizes of bioreactors, each of which can operate according…

Navigating Technology Transfer

Technology transfer is a key milestone in the journey from discovery to full-scale good manufacturing practice (GMP)-compliant manufacturing. Navigating this step while preventing unforeseen issues that can create costly delays is supported best by combining knowledge of a given process with understanding of the technological capabilities. Different applications have different needs. Some challenges and goals are common to bioreactor processes for suspension and adherent cell culture for production of viral vectors, monoclonal antibodies (MAbs), other recombinant proteins, and vaccines. All…

Industrialize Your Viral Vector Production in Adherent and Suspension Cell Cultures: Know the Pros and Cons

This educational podcast, “The Evolution of Culture Systems for Viral Vector Production: Advantages, Challenges and Cost Considerations,” recently published by Cell and Gene Therapy Insights, discusses in detail the pros and cons of viral vector production in adherent and suspension cell culture. This special report illustrates how Pall Biotech’s iCELLis 500+ bioreactors and Allegro STR bioreactors can bolster adherent and suspension culture, respectively, for viral vector production. Fill out the form below to read the complete report and learn more now.…

Implementation of Single-Use Miniature Bioreactors to Support Intensified Cell Culture: Using Functional Performance Indicators to Assess a Small‑Scale Model

Changes to bioprocessing in the biopharmaceutical industry are driven by the need for increased speed, lower cost of goods (CoG), and greater flexibility (1). To meet these challenges, the industry is adopting strategies that include intensified processing. During the initial stages of intensified processing, it is essential to identify the most productive and/or stable clones for use before starting pilot-scale studies. That requires screening large numbers of clones and then further testing the most promising ones in benchtop bioreactors. The…

Matrix: The Highly Automated Multibioreactor Solution That Fits to Your Bench Space, Bioprocessing Needs, and Budget

To improve their bioprocess performance, life-science specialists need flexibility in their R&D laboratories because of constantly changing bioprocessing demands. In addition, more experiments need to be performed with more accuracy and reproducibility on less bench space than ever before — and with limited budgets. Therefore, having flexibility in the number of bioreactors that fit available bench space and budget is crucial — along with the flexibility to connect and integrate the right software, sampling tools, and analytical devices. Running multiple…

From Supplying Components to Providing Total Solutions: Overviewing Supplier Side Capabilities

Only a thin line now separates biopharmaceutical manufacturers and suppliers because the latter are increasingly becoming the process knowledge owners in the biopharmaceutical industry. As a result, suppliers are racing to become the most efficient “total solutions” provider. In the 1990s, leading players in the industry such as Pall, Millipore, and Sartorius all supplied membrane filters for upstream and, to some extent, downstream processes with their crossflow and final filtration offerings. Pharmacia (which became GE Healthcare) was the major force…

Production of Transient Lentiviral Vectors in HEK 293T Cells: Cultivation on Fibra-Cel Disks in a Single-Use, Packed-Bed, Stirred-Tank Bioreactor

Although demand for lentiviral vectors (LVs) for cell and gene therapy is increasing, the standard two-dimensional culture systems used to produce LVs present significant disadvantages. Current bottlenecks in LV production are caused mainly by such disadvantages. Switching to use of bioreactors can eliminate those problems because bioreactors offer the benefits of process automation, tight regulation of production conditions, and reduced labor input. The study reported herein was carried out by the group of David Parsons at the University of Adelaide.…