July 2008

Reducing Elution Volumes with High Capacity and Improved Mass Transfer Ion Exchange Resins

Figure 1. At recent scientific conferences on downstream processing, there was much discussion about the need to reduce process volumes. Many manufacturing sites are space-limited and to take advantage of chromatographic process improvements, they must be made without the need to increase buffer and holding tankage. One significant opportunity to increase process throughput is to replace conventional with higher capacity ion exchange resins. Recently developed high capacity resins allow more protein to be loaded without the need to replace existing…

Preparative Peptide Purification

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…

The Global Biotech Community’s One-Source Contract Manufacturing Solution

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…

From Cell Line Optimization to Aseptic Filling

The biopharmaceutical industry is faced with a challenging task: planning, developing, manufacturing, and bringing to market a highly specialized and complex biopharmaceutical product. Competitive pressures, cost, and — above all — time to market are of key concern. The wide range of implementation options, from in-house resources to outsourcing companies of various calibers and capabilities, adds yet another layer of complexity to the decision-making process. Our objective is to offer our customers a full-service alternative to the development and manufacturing…

Supplements for Enhanced Cell Productivity

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…

Holistic Solutions Available As Single Parts

Bioengineering AG has 30 years of experience in the construction of hygienic plants. Thereby holistic process equipment from the feed line to the valve system for the final cleaning has become the status quo. Our new BioAccessories department focuses on all our components and accessories. Now you do not need a Bioengineering system to be able to use our developments. For special applications we offer the possibility of custom-made or even newly developed parts. Safety with Leak-Proof Couplings: Sterility begins…

Closed-Loop Solutions to Improve Efficiencies and Yields Using Automated Online Sampling Systems for Bioreactors

Improving production quality, efficiency, and yield is the objective of every commercial biotechnology process. Automation of assay tasks now routinely performed manually directly improves production bioprocesses. The US FDA supports and encourages this activity through the process analytical technology (PAT) initiative within its regulatory structure. The features and benefits of the online series of Automated Reactor Sampling (ARS-M™) systems supplied by Groton Biosystems are detailed here. Online Automatic Assays Today the most vital late-stage and production assay measurements — with…

Purification of a Monoclonal Antibody Using a Combination of UNOsphere™ Rapid S and UNOsphere Q Media Ion Exchange Chromatography After Protein A Capture

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…

Developing Scalable, Robust Processes That Result in Stable, Active Products

KBI Biopharma is a leading contract development organization for the biopharmaceutical industry. We accelerate and optimize drug development and manufacturing programs for our client partners, including global pharmaceutical and biotechnology companies and organizations in biodefense. Our clients benefit from faster time to market and lower cost of manufactured goods. Ongoing Innovation We are continually working on new technologies and new partnership opportunities to enhance biomanufacturing. Our expertise in biophysical and biochemical protein characterization makes us highly successful in delivering optimal…

Cellastim™ Recombinant Human Serum Albumin

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…