The increasing popularity of “single-use” or disposable bioreactors for upstream processing can be understood by considering a typical biotechnology manufacturing facility. The infrastructure required to implement traditional glass/steel bioreactors is substantial, and the time and expense required to validate it can be significant. The requirement that both the bioreactor itself and its ingress and egress tubing use inert materials such as 316-L electropolished stainless steel results in a large capital investment and long lead times for components. In addition to…

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…

Figure 1. Select promising leads earlier in the development process with the Octet RED system’s rapid, highly sensitive detection and label-free analysis of small peptides and small molecules. The Octet RED system’s rapid data acquisition and high sensitivity means that even the fastest reactions and smallest binders will be easily characterized. The Octet RED system shares the advantages of the Octet QK system: BLI technology, no microfluidics, eight-channel parallel processing, walk-away automation of up to 96 samples, and affordability —…

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…

Upfront Chromatography A/S is a Danish company with significant expertise in the development of customized industrial processes. Successful operation of industrial separations provides proven scalability for biopharmaceutical manufacturers. Upfront Chromatography’s Rhobust™ technology has been developed to maximize the effectiveness of capture adsorption steps, using second-generation expanded-bed technology. Rhobust™ consists of Mixed-mode ligand chemistry (robust adsorbents with added selectivity) Tungsten carbide densified agarose that enables robust operation of expanded bed Dedicated hardware designs (robust fluid distribution systems without meshes, frits, or…

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…

Biopharmaceutical companies continue to wrestle with how to approach the implementation of process analytical technology (PAT). The accelerated adoption of many new technologies has benefited from the identification of a “killer app,” an early application that enables a readily achieved breakthrough in capability. This can be a totally new capability (e.g., e-mail on the internet) or a major step-change (e.g., 10× or more) in an existing capability. Flashes of inspiration cannot be achieved at will, but we can identify elements…

Figure 1. The demand for biopharmaceutical products is increasing rapidly; however, development timelines of about 12 years leave little time for return on investment before a patent expires. Fast process development is therefore crucial to speed up the market entrance of new biopharmaceuticals. Until recently, chromatographic process development was restricted to a sequential regime. However, new innovative methods have been developed to perform up to 96 parallel chromatographic experiments on a Tecan Freedom EVO® robotic workstation (pictured, right), allowing for…

Invitrogen has 45 years of experience in the cell culture business. Over this time, the Invitrogen name and reputation has made us the recognized leader in cell culture systems. In 2003, Invitrogen expanded on this tradition in innovative cell culture products through the creation of a team focused on process development, PD-Direct® BioProcess services. The PD-Direct team responds to core customer needs by offering customers comprehensive service from cell line and media development, to process optimization. Upstream Optimization Services The…

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…