Figure 1. Fed-batch versions of stirred-tank cell culture have become most popular at large scales. The primary driver of a mid-run addition of nutrients to batch cultures is to increase the quantity of product harvested. The prevalence of fed-batch over other modes is attributable to many practical factors such as reliability, scalability, and application latitude. Increases in the integral of viable cell concentration and volumetric productivity are commonly the greatest improvements obtained (1). Factors determining optimum feeding of cultures include…

SAFC Biosciences views supply chain management as a structured process that seeks to evaluate, monitor and control supply chain risk, safeguarding continuity while maximizing profitability for its supply chain partners. Successful supply chain management in the biopharmaceutical industry is no longer simply a case of having the right material in the right place at the right time to guard against production delays. Today, the basis of our supply chain offering includes risk mitigation, robust supplier relationship management and critical raw…

Figure 1. With over 60 years experience in microbial protein expression, Novozymes offers a range of animal-free recombinant supplements — designed and manufactured exclusively for industrial cell culture — that allow developers to “rethink” their media strategy. These products provide proven performance benefits in a defined and regulatory-compliant manner, ensuring optimal media development for enhanced cell productivity. Recombinant Human Albumin (rHA) Novozymes has developed a range of rHas (Recombumin®, albucult™, and CellPrime™ ralbumin AF-S) suitable for industrial cell culture and…

Figure 1. Albumin is used in cell culture media as a replacement for serum because of its positive effect on cell growth and productivity (1,2,3). Albumin is a known transporter of nutrients, lipids, and it removes toxins and waste products (2,3). Albumin is a classic performance-enhancing ingredient in many serum-free media formulations (1). However beneficial, plasma-derived albumin is undesirable because animal products present potential contamination by infectious agents. Cellastim™ recombinant human serum albumin is an animal-free albumin specifically developed for…

Figure 1. As a leading provider of process and analytical solutions for the biotechnology and pharmaceutical industries, Applied Biosystems offers an extensive portfolio of tools to help optimize every stage of biopharmaceutical production — from characterization to purification to pharmaceutical manufacturing. These solutions provide pharmaceutical manufacturers with the tools they require to maximize throughput and yield and ensure product quality. Purification High Performance on a Large Scale: Applied Biosystems POROS Perfusion Chromatography products are today’s best-performing chromatographic media for process-scale…

Figure 1. Manufacture of synthetic peptides ranges from milligram to multikilogram amounts. When a peptide is a biopharmaceutical (API) candidate, the amount required will increase as it moves through clinical trials to marketed product. When developing purification methods, the required “product” API quantity and purity should be considered. Bradykinin is a physiologically and pharmacologically active peptide of the kinin family used in development of antagonists and therapies for hereditary angioedema. Here we describe two different methods of purifying a crude…

Photo 1. Biopharmaceutical processing has been greatly improved over the past 10 years with the introduction of single-use/disposable technology. There has been a landslide of disposable products introduced in the areas of filtration, mixing, sampling, and transferring solutions aseptically. It is common to find papers and studies that detail the efficiencies that disposables offer to the biopharmaceutical market. What about aseptic filling? More importantly, what about the cost of aseptic filling? PDC aseptic Filling Systems offers an answer. The biopharmaceutical…

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. 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. 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…