Figure 1. A virus validation study is required for virus-removal filters prior to employing them in a biopharmaceutical purification process. Validation conditions are determined on a case-by-case basis by each filter user. Optimizing conditions for removal of parvovirus is important to achieve LRV = 4. However, the optimal conditions are often unclear for validation studies, because each product may behave differently. We attempt to establish optimal conditions for human IgG and show the effects of varying IgG concentration, purity of the virus…

Figure 1. CIM Convective interaction Media® are monolithic chromatographic supports used for purification of plasmid DNA, viruses, and other large biomolecules on a laboratory and industrial scale. CIM® monoliths are characterized by large flow-through channels (average diameter of 1,500 nm), which enhance the mass transfer between the mobile and stationary phase. This results in a high and flow-independent dynamic binding capacity and resolution. For plasmid DNA purification on an industrial level, these characteristics increase productivity, making CIM® monolithic columns attractive…

Figure 1. Accurate and rapid IgG titer determination is critical in the selection of cell lines and culture development for antibody production. ForteBio’s Octet QK and Octet RED Systems provide rapid and accurate IgG quantitation in a label-free format that is easy to use. The Octet family of instruments offers analytical capabilities that provide greater value in applications where existing methods such as HPLC and ELISA have limitations in throughput, performance, workflow, and ease of use. Principle Different protein concentrations…

Figure 1. Finding optimal conditions for a downstream purification process is critical to achieving high productivity and a robust biopharmaceutical manufacturing process at large scale. In addition, the FDA’s new Quality by design initiative may increase demands on process development work because a higher degree of process understanding must be acquired. This understanding/knowledge can be obtained if a larger experimental space is considered and/or more detailed studies are performed. The introduction of high-throughput techniques for process development partially addresses these…

Figure 1. Tangential-flow filtration (TFF) cassette operations are known for reusable cassettes; however, a single-use model is less established because production-scale single-use TFF cassettes are not readily available. Novasep (through TangenX Technology Corp.) offers the first presanitized, purposely built, single-use TFF cassette for the biopharmaceutical industry. Sius™ cassettes have been designed to offer performance comparable with that of reusable products at a fraction of the cost. Each cassette arrives presanitized, ready to be equilibrated with buffer and used for processing.…

Figure 1. Monoclonal antibodies (MAbs) are expected to dominate the future biopharmaceutical landscape (1). Although chromatography is the mainstay of MAb downstream purification processes, more efficient and cost-effective chromatography technologies are needed to address increasing MAb titers in mammalian cell culture supernatants. Ion-exchange membrane chromatography has been demonstrated to capture large biomolecules such as viruses and plasmid DNA with higher dynamic binding capacity than ion-exchange beaded column chromatography (2, 3). Recently, anion-exchange membrane chromatography has been viewed as a viable…

Figure 1. Antibody-based drugs represent a growing segment of the pharmaceutical industry and one of the most promising classes of therapeutic drugs. The demand for protein-based drugs is expected to grow steadily for the foreseeable future. However, production of monoclonal antibody (MAb)–based drugs remains very costly, and solutions to lower production costs are needed. Downstream purification steps are becoming a target for cost reduction. The use of ion-exchange chromatography to directly capture MAbs from cell culture streams or as a…

Cook Pharmica is a full-service biopharmaceutical contract manufacturer located in Bloomington, IN. Cook Pharmica’s mission is to provide process development, flexible manufacturing, and comprehensive analytical services to the global biotech community; enabling its partners to bring their life-saving discoveries to patients. And with the recent announcement of its expansion into parenteral contract manufacturing, Cook Pharmica will serve the industry as a complete one-source solution. The current API manufacturing facility was designed to support clinical and small-scale commercial products and features…

Figure 1. Effectively working with a contract manufacturer’s project management team to ensure project success is a key goal for not only Althea Technologies, but for all companies working on difficult and complex manufacturing projects. Project management tools are widely used to effectively manage biotechnology and pharmaceutical product development. Implementing a project management office (PMO) is still a challenging undertaking for a contract manufacturing organization that has a wide array of project requirements to address. There are a number of…

Figure 1. Optimization of key factors in a biopharmaceutical process is necessary to meet the continuous rise in production demands. Choice of cell culture media and peptone supplementation is critical to process performance. However, medium development can be a multifaceted process requiring a large number of resources. To comprehensively cover all variables with the least time and effort, statistical methods are employed. Using statistical methods can help identify an animal free (AF) peptone that effectively enhances protein production for a…