July 2008

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…

Mixing and Resuspension of High Powder Loads Using a Magnetic Mixer

Figure 1. The Newmix-Levtech Magnetic Mixer system is a compact and noninvasive single-use mixing system. Its heart is a mixing bag that incorporates an innovative, bottom-mounted, magnetically driven impeller capable of providing efficient high-torque mixing for all powder-liquid and liquid-liquid mixing applications. The impeller rides on a low-friction, inert bearing assembly designed to ensure low particle shedding while allowing mixing of very high powder loads in large liquid volumes. All product-contacting surfaces are 100% disposable. Introduction Powder-liquid mixing is a…

Method for Evaluating Bio-Container Transportation Applications

Figure 1. Single-use components are finding more use in the biopharmaceutical industry. One application increasing in use is transportation of sterile liquids. There are many challenges to consider when shipping a flexible container with sterile liquids. Typical Bio-Containers used in shipping applications are constructed of multiple layers. The fluid-contact layer is typically constructed of low, linear low, or ultralow density polyethylene (LDPE, LLDPE, or ULDPE). A variety of gasbarrier layers can be used in construction of the multilayer film, and…

Contaminant Removal by Mustang® Q Membrane Chromatography from a Protein A-Purified Monoclonal Antibody

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…

CMC Continues to Grow

With expansion of production capacity, range of services, and customer base, CMC continues to grow. Earlier this year, CMC acquired the former ICOS Biologics development and manufacturing facility in Seattle, WA, from Eli Lilly. Now known as CMC ICOS Biologics, this facility focuses primarily on mammalian production, and during 2008 it is being upgraded to enable production of in-market biopharmaceuticals as well as late-stage clinical trial material. Dr. Gustavo Mahler, previously with Bayer Healthcare, has been appointed president of CMC…

Optimization of Peptone Supplementation in the Development of a High-Performance CHO Growth and Production Medium

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…