Applikon Biotechnology BV (in the Netherlands) and Aber Instruments Ltd. (in the United Kingdom) have entered into an agreement for the exclusive supply of the first integrated bioreactor controller and sensor for viable cells on the market. Applikon Biotechnology will offer the viable cell sensor and controller option in its EZ Control bioprocess controller portfolio designed for the biotechnological and biopharmaceutical industries. The Aber Biomass Monitor uses a unique in situ probe that incorporates four annular ring electrodes to apply…
July 2008
Advanced Scientifics’ Single Use Systems
Who Is Advanced Scientifics? Advanced Scientifics is an ISO 13485:2003, FDA registered global leader in the design and manufacture of single use systems for the Pharmaceutical and Biotech industries. Our vast array of manufacturing capabilities allows us to provide a custom disposable system in some of the industry’s shortest lead times. From system design, to the highest standard in quality production and assembly, to final packaging and sterilization, advanced Scientifics is your complete single use systems provider. Facilities Advanced Scientifics…
Microfluidics Offers M-110P Microfluidizer® Processor
Microfluidics offers its M-110P Microfluidizer® processor, a benchtop laboratory machine that requires no compressed air or cooling water for hydraulics. Designed to operate reliably, quietly, and efficiently at up to 30,000 psi process pressures, the portable M-110P requires only a standard 20-amp, single-phase “household” electrical outlet and can easily be incorporated into any laboratory setting. Using Microfluidics’ fixed geometry diamond interaction chamber technology and ceramic plunger, the M-110P easily enables the production of nanosuspensions and nanoemulsions, as well as liposomal…
Take the Laboratory to the Sample: Implementing PAT with Miniature Modular Technology
Figure 1. The pharmaceutical industry has relied on laboratory testing for all of the past century. Typically, biopharmaceuticals are manufactured in batches and tested for quality using off-line laboratory test methods of samples extracted from the process line. However, taking the laboratory to the sample changes the way analyses are conducted. The FDA Guidance for industry, PAT: A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance, promulgated in final form in September 2004, encourages the use of available process…
Rapid Profiling of Reduced and Intact Monoclonal Antibodies By LC/ESI-TOF MS
Figure 1. As the pharmaceutical industry focuses on developing biotechnology-derived drugs, bioanalytical groups must produce generic methodologies for antibody characterization with higher throughput and faster sample turnaround times. Although antibody selectivity varies, overall antibody structures are highly conserved. Intact antibody LC/MS analysis is useful for profiling glycovariants and C-terminal Lys processing, and even more information can be gleaned from analysis of a reduced antibody. UltraPerformance LC® (UPLC®) technology permits efficient desalting and rapid LC/MS mass profiling of an intact (4…
Designed for Advanced Application
Emerging lifestyle diseases and an aging population are creating a number of major health challenges. Over the past few years, the food industry has been more focused on functional foods, those intended to be consumed within the normal diet but containing biologically active components with physiological benefits intended to reduce certain chronic diseases. This US$35 billion market has been steadily growing at 8-14% per year, as estimated by the Food and Agriculture Organization of the United States (FAO). Although the…
Octet RED System
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 —…
Single-Use Solutions
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…
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…
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…