July 2010

Process Development for Cell-Based Influenza Vaccine

          Influenza virus vaccines have traditionally been produced by infection of fertilized hen eggs. This labor-intensive approach requires large facilities, which has led to the development of large-scale mammalian cell culture methods for future virus vaccine production processes. The main focus of these studies was to use generic, established, and scalable techniques for industrial production of live influenza vaccines (Figure 1) and potentially also for other viruses independent of type or size. Development of three different…

Turn-Key Bioreactor Solutions

        top) and TruBio µC (bottom ()   In order to reduce scale-up costs and facility capital expenses, biotechnology companies are adopting single-use systems. To fully enable the single-use paradigm, automation software, hardware, and single-use sensors must be optimized; moreover, both validation documents and materials certifications must be readily available for cGMP implementations. Finesse provides turn-key, configure-to-order measurement and automation solutions for many single-use bioreactor types: “stirred-tank,” “paddle,” or “rocker” systems. The Finesse turn-key system is optimized…

Simple, Innovative Technology Improves QC Processes and Streamlines Production

          As production facilities strive for greater efficiency, a common practice is to seek process improvements in quality control (QC) operations. All production facilities share some common requirements for these QC checks, especially that they can be fast, simple, proven, and economical. In addition to this, the production of biological materials such as proteins frequently presents additional requirements, including the need to perform QC tests using very small volumes and the ability to measure the protein…