Throughout its 50-year history, WL Gore & Associates has earned its reputation for providing innovative, high-value products such as GORE-TEX® outerwear, Elixir® guitar strings, and GORE-TEX® vascular grafts. Having invented expanded polytetrafluoroethylene (ePTFE), Gore offers an unparalleled level of technical knowledge and experience with this versatile material. This know-how starts with a deep scientific understanding of fluoropolymers, particularly PTFE processing and fluoropolymer development. Gore’s unique technical agility enables the development of a wide range of processes, products, and creative, reliable…

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…

Figure 1. The costs of producing monoclonal antibodies (MAbs) from mammalian cells are extremely high. Producing 500 kg/year of a MAb can run $200,000,000/year or more. Great effort has been made by the biopharmaceutical industry to reduce these costs. Companies have improved or expanded their existing infrastructures for MAb manufacturing, optimized media formulations and feeds, and/or genetically engineered production cell lines, with the current industry goal of 10 g/L titers and productivities of 100 picograms/cell/day. A twofold increase in volumetric…

Figure 1. AmProtein Corporation is a biotechnology powerhouse that has revolutionized the biologics industry with the discovery of a novel expression vector and development of a disposable bioreactor series. AmProtein has used these two discoveries to develop an unbelievably simple and efficient, industrialized CHO cell protein production platform. This platform includes a revolutionary expression vector; a single-use, plastic bag-based bioreactor system based on a novel, patented O2 transfer method; and serum-free cell culture media. The platform is scalable from bench…

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…

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…

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…

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…

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…

Biopharmaceutical manufacturers face increased pressure to commercialize new drugs faster and at a lower cost. As a result, production demand is outpacing available manufacturing capacity. To meet existing and future demand and maintain a competitive advantage, many manufacturers are striving to develop increased efficiencies within their manufacturing processes. This is where single-use systems — particularly single-use transfer lines — can deliver significant value, including added flexibility, improved production yields, and increased cost savings. The trend today is toward transfer lines…