Influenza vaccine has historically been produced in embryonated chicken eggs. However, to meet the needs for pandemic preparedness and the scalability of vaccine production, cell-based processes are now being developed and implemented in the industry. The methods for purification processes have typically involved a combination of sucrose density gradient ultracentrifugation, ultrafiltration/diafiltration (UF/DF) with hollow-fiber membranes, and chromatography using affinity, ion-exchange, and/or gel filtration media (resins). In these processes, both sucrose density gradient ultracentrifugation and gel filtration have…

    Figure 1: ()   Antibody fragments (e.g., Fab, scFv, DAb, etc.) are set to become the next important class of protein-based biotherapeutics after monoclonal antibodies (MAbs). One of the advantages is that due to their structure and smaller size, antibody fragments possess unique properties (e.g., easier tissue penetration) that suit a range of diagnostic and therapeutic applications. The industry standard for purifying MAbs is a platform approach using affinity chromatography with protein A as the capture step. The…

      Protein A chromatography is still the preferred capture step in monoclonal antibody (MAb) production because of its high selectivity and robustness, although cation-exchange (CEX) or multimode chromatography techniques are claimed as alternatives. Kaneka Protein A Cellulose increases the value of protein A affinity chromatography for MAb production. Kaneka’s unique combination of a proprietary designed alkaline stable protein A ligand and a highly cross-linked cellulose base matrix meets customer requirements for improved performance, high binding capacity, alkaline and…

      LEWA developed its first pulseless pump for liquid chromatography in the late 1970s and delivered its first chromatography system in the early 1980s. LEWA is the leader in supplying pumps used for pilot and industrial HPLC, SMB, and LPLC chromatography worldwide. A customer came to us several years ago requesting a low-pressure liquid chromatography system with a flow range of 20–2,200 L/h. They also wanted the ability to achieve linear gradient from 1 to 99%. We designed…

      Anion-exchange (AEX) products are commonly used as a polish step in product flow-through (FT) mode to bind impurities. Comparing resins with membranes and membranes with membranes is challenging because of the complicated and unique scaled-down model formats of the products offered by different vendors. A novel approach to AEX FT using a short, 5-cm length, packed-bed format with a faster operating flow rate is explained. The performance of commonly used AEX resins and membrane adsorbers, detailing dynamic…

The capture step in the downstream processing of monoclonal antibodies (MAbs) is often the bottleneck and the most expensive step due to the use of protein A media. In recent years, several new-generation protein A media have been launched on the market claiming improved MAb capture, or improved resistance to cleaning agents. AbSolute® High Cap, the new revolutionary protein A media by Novasep, maintains excellent DBCs at low and high velocities, therefore, providing substantially improved productivity and strongly reduced costs…

    Figure 1: Sartopore® Platinum TwinPleat ()   Sterile filtration using 0.2-µm rated filters is a critical step in upstream and downstream biomanufacturing alike. Typical applications comprise sterile media addition into the bioreactors, cell harvest clarification post-depth filter, chromatography column protection, and final sterile filtration of purified bulk drug substance. Total throughput, flow rate, unspecific adsorption, and wettability of sterile filters can have direct impact on total cost of ownership. There have been innovative application-specific approaches in sterile filtration…

Speed to market has become a key factor of success in the biopharmaceutical industry, yet it can be difficult to achieve without compromising product quality. By seeking out products that are able to provide maximum efficiency while simultaneously maintaining first-rate quality, companies can not only get to market quicker, but also gain a competitive advantage. A new bag port line, manufactured by Value Plastics (VP), both addresses these concerns and tackles them head on by incorporating them into the product…

      Cation exchange resins are used in many protein purifications. The high capacity of these resins is very important to process throughput particularly as protein expression levels reach titers >10 g/L. In many cases the feedstock may need to be diluted before loading onto a cation exchange resin to maintain the high protein dynamic binding capacity (DBC) reported by the manufacturer. The additional water, buffer volumes, and process time add cost to the loading step. Tosoh Bioscience is…

      Single-use technologies are a growing market and becoming increasingly common in biopharmaceutical manufacturing. Because of this growth and their increasing use in further reaches of upstream and downstream processes, understanding the safety and sanitation of single-use technology is vital. One of the key benefits of single-use systems is their potential to eliminate cross-contamination during pharmaceutical manufacturing. In processes that are entirely single-use, replacement of the fluid path assembly during production eliminates the concern for contamination in any…