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The growing demand for immunoglobulin (IG) requires development of improved plasma fractionation methods to provide higher yields in a cost effective, scalable manner without compromising product purity and efficacy. A novel protein extraction method, utilizing expanded bed adsorption (EBA) chromatography, has been developed. PlasmaCap IG (10% liquid formulation intravenous IG [IVIG]) is the first plasma-derived product manufactured using PlasmaCap EBA technology.The PlasmaCap EBA platform consists of a series of consecutive columns which bind a target protein, or group of proteins, in their native state directly from cryo-poor plasma. EBA chromatography includes five key steps: (1) expand, (2) sanitize and equilibrate, (3) load, (4) wash and (5) elute. These steps are made possible using high-density tungsten-carbide agarose beads, suspended by upward flow. The PlasmaCap EBA process was evaluated during Evolve's clinical campaign for scalability, product quality and yield.PlasmaCap EBA technology can be predictably scaled by maintaining the minimum residence time and residence time distribution for EBA columns of different diameters. Scalability of the manufacturing process was demonstrated by the 50-fold volumetric increase from laboratory-scale lots to clinical-scale lots. The process is also associated with enhanced product purity, such as lower aggregates. The PlasmaCap EBA process is expected to have the same or better yield and purity at commercial scale production compared to the clinical campaign.The PlasmaCap EBA platform was used to successfully develop PlasmaCap IG (10% liquid formulation IVIG) with proven scalability, product quality and yield.

There are new prospects for the use of extruded aluminium for structurally loaded components such as in the wheel suspension or for stabilizing. Connecting links made from chamber-extruded wrought aluminium alloy for instance show superior properties when compared to the widely used steel designs with ball joints. The potential of this wrought alloy in combination with high-performance slit elastomer/steel bearings is explored by the companies Vorwerk autotec and B&T Exact on the basis of the connecting link module in the Porsche Cayenne’s front axle.

This Corrective Action Decision Document (CADD) presents information supporting the selection of corrective action alternatives (CAAs) leading to the closure of Corrective Action Unit (CAU) 562, Waste Systems, in Areas 2, 23, and 25 of the Nevada Test Site, Nevada. This complies with the requirements of the Federal Facility Agreement and Consent Order (FFACO) that was agreed to by the State of Nevada; U.S. Department of Energy (DOE), Environmental Management; U.S. Department of Defense; and DOE, Legacy Management. Corrective Action Unit 562 comprises the following corrective action sites (CASs): • 02-26-11, Lead Shot • 02-44-02, Paint Spills and French Drain • 02-59-01, Septic System • 02-60-01, Concrete Drain • 02-60-02, French Drain • 02-60-03, Steam Cleaning Drain • 02-60-04, French Drain • 02-60-05, French Drain • 02-60-06, French Drain • 02-60-07, French Drain • 23-60-01, Mud Trap Drain and Outfall • 23-99-06, Grease Trap • 25-60-04, Building 3123 Outfalls The purpose of this CADD is to identify and provide the rationale for the recommendation of CAAs for the 13 CASs within CAU 562. Corrective action investigation (CAI) activities were performed from July 27, 2009, through May 12, 2010, as set forth in the CAU 562 Corrective Action Investigation Plan. The purpose of the CAI was to fulfill the following data needs as defined during the more » data quality objective (DQO) process: • Determine whether COCs are present. • If COCs are present, determine their nature and extent. • Provide sufficient information and data to complete appropriate corrective actions. A data quality assessment (DQA) performed on the CAU 562 data demonstrated the quality and acceptability of the data for use in fulfilling the DQO data needs. Analytes detected during the CAI were evaluated against appropriate final action levels (FALs) to identify the COCs for each CAS. The results of the CAI identified COCs at 10 of the 13 CASs in CAU 562, and thus corrective action is required. Assessment of the data generated from investigation activities conducted at CAU 562 is shown in Table ES-1. Based on the evaluation of analytical data from the CAI, review of future and current operations at the 13 CASs, and the detailed and comparative analysis of the potential CAAs, the following corrective actions are recommended for CAU 562. • No further action is the preferred corrective action for CASs 02-60-01, 02-60-06, and 02-60-07. • Clean closure is the preferred corrective action for CASs 02-26-11, 02-44-02, 02-59-01, 02-60-02, 02-60-03, 02-60-04, 02-60-05, 23-60-01, 23-99-06, and 25-60-04. The preferred CAAs were evaluated on technical merit focusing on performance, reliability, feasibility, safety, and cost. The alternatives were judged to meet all requirements for the technical components evaluated. The alternatives meet all applicable federal and state regulations for closure of the site and will reduce potential exposures to contaminated media to acceptable levels. The DOE, National Nuclear Security Administration Nevada Site Office provides the following recommendations: • No further corrective action is required at CASs 02-60-01, 02-60-06, and 02-60-07. • Clean closure is recommended for the remaining 10 CASs in CAU 562. • A Corrective Action Plan will be submitted to the Nevada Division of Environmental Protection that contains a detailed description of the proposed actions that will be taken to implement the selected corrective actions. « less

A simulation model for millet-cowpea intercrop is presented. The model is developed within the generic GROWIT framework and uses a spreadsheet, In addition, a spreadsheet template is used for making stochastic dominance comparisons. The millet-cowpea model and the stochastic dominance spreadsheet are applied to the evaluation of millet and cowpea production strategies in Niger, West Africa. The validations suggest that the model captures the main tendencies of the yield distribution. In the economic analysis, simulation-derived distributions were used to rank crop production strategies according to risk characteristics using the stochastic dominance template. The simulation results complemented information from yield trials and reinforced the conclusion that a technology incorporating improved varieties, higher plant population and fertilizer has potential in south central Niger. In particular, the analysis showed that the risk characteristics of this technology could be acceptable to farmers, in comparison with the traditional practices.