Figure 1. Established in 1997, integrated Genomics (IG) provides a full range of products and services to support research in microbial genomics, metabolic analysis, and engineering. Our flagship genome analysis system, ERGO™, provides a bioinformatics toolkit enabling better and faster identification of gene function and pathways across organisms, which is evident within more than 100 scientific publications in top peer-reviewed journals (www.integratedgenomics.com/igpubs.html). The ERGO in silico metabolic discovery and analysis tool set is the world’s largest commercially available database of…

Figure 1. How well does absorbance correlate with cell density and viability measurements in batch and fed-batch cell culture? As expected in science and nature, the answer depends on a set of factors. Many people working with batch or fed-batch cell culture will reference discrete offline measures of cell activity. Total cell density (TCD), viable cell density (VCD), and percent viability can be evaluated offline using a hemocytometer and accepted trypan blue exclusion method. Cedex® and Vi-CELL™ are two examples…

Whether applied to business security, product specification, financial exposure or personnel safety, quality is a key element underpinning any biopharmaceutical risk mitigation strategy. A quality system should not be inherently dependent upon personnel, nor should it rely solely on people to ensure the quality of the products manufactured. Irrespective of human resources, the system itself should provide consistency, addressing risk from design inception through to product delivery, ensuring that robust processes are in place that minimize risk to the product…

Photo 1. Demand for single-use bioprocess systems in the biotech and pharmaceutical industry has increased significantly in recent years. Among other reasons — such as operations, sourcing, and validation — their lower initial investment capital makes disposable systems very attractive for the pharmaceutical industry. When Wave Biotech introduced the first wave-action reactor/mixer, it was seen by some as the start of single-use technology. Once containers become single-use, all other parts of the manufacturing process ideally have to follow the same…

The development of single-use bioreactor technologies is focused on bringing new designs onto the market for effective oxygen transfer and cultivation of not only cell culture processes, but also microbial cultures. The advantages of disposable technologies are: ease of use, prevention of cross-contamination, labor and capital investment savings, reduced qualification and validation, and increased flexibility. The costs of disposables are lower compared with conventional stainless-steel bioreactors because the capital investment is lower. Therefore, the need is reduced for qualification and…

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. 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. 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.…