To achive the coarse purification of a monoclonal antibody from whole hybridoma fermentation broth a fluidized bed cation exchange process was used. The procedure consisted of application of the crude sample and washing of the bed in a fluidized mode and elution in a fixed bed mode. A completely clarified eluate was obtained with purification factors between 4 and 8 and a concentration of the desired product (monoclonal antibody) by a factor of more than 3 was achived. Thus, a combination of the three early steps of the downstream process clarification, concentration and coarse purification was possible. Two different materials were tested: a commercially available agarose-based matrix (Stream-line-SP), and a self-derivatized material based on controlled-pore glass (Bioran). Initial experiments were performed to describe the fluidization of the glass material. Comparison with the agarose material showed several differences, the agarose matrix allowing liquid flow closer to plug flow than the glass material. Increased backmixing in the liquid phase was detected when fluidizing the glass adsorbent compared with the agarose-based matrix. Despite this fact, comparison of the two materials with respect to antibody binding and elution demonstrated a similar performance. (c) 1995 John Wiley & Sons, Inc.
Objectives To report participant recruitment experiences in a large, US randomized controlled trial (RCT) of lung cancer screening, with the aim of providing information that may be of use to researchers who wish to conduct similar future studies. Setting The National Lung Screening Trial (NLST), an RCT that demonstrated a 20% lung cancer mortality reduction with low dose helical computed tomography screening, relative to single-view chest radiograph screening. Thirty-three US medical centres recruited 53,454 participants from August 2002 through April 2004. Methods After recruitment was completed, centre co-ordinators were asked to complete a questionnaire addressing the extent to which specific methods were used and, for each specific method, numbers enrolled and total cost of the effort. Cost per enrollee was calculated. Coordinators also were asked to report lessons learned. Results Twenty-two centres returned questionnaires. Use of recruitment method varied by centre. Among centres reporting number enrolled by method, about 19,000 participants were enrolled with direct mail, about 4200 with mass media, and about 1000 with community outreach. Cost per enrollee varied across centres but medians were (US)$101 (direct mail), $79 (mass media), and $4 (community outreach). Co-ordinators reported that it was important to know where to find persons likely to be eligible and interested, and how best to approach them. Conclusions Most NLST participants were recruited through direct mail, although median cost per participant was highest for that method.
1. There appears to be a relationship among the improved overall behavior of this patient, anatomical changes in the brain, and enhanced performance of both psychophysical and electrophysiological central auditory tests.2. The right-sided peripheral hearing loss was one of the primary indicators for further diagnostic workup, but probably is unrelated to the lesion that was later discovered.3. In demonstrating structural as well as functional improvement, this case demonstrates the plasticity of the young human brain.
Rationale and Objectives As one of the newest cooperative groups funded by the National Cancer Institute in 1999, the American College of Radiology Imaging Network (ACRIN) is interested in conducting successful clinical research programs and pursuing quality research. The ACRIN Research Associate (RA) committee was formed in 2000 and felt it important to better understand the demographics, duties, needs, and concerns of ACRIN RAs. Therefore, in 2008, the committee conducted a survey of ACRIN RAs regarding these issues. Materials and Methods The survey instrument consisted of 33 multiple choice questions covering demographics, salary, job satisfaction, work load, educational background, and training. RAs completed the survey electronically in June 2008. Results A total of 110 responses were received. All regions of the United States were represented. The years of experience and salary ranged widely from <1 year to 28 years and ≤$20,000 to ≥$80,000 per year. The majority of respondents held at least a bachelor’s degree, with many having previous health-related clinical training; only a small percentage of respondents having had formal training in research. Conclusion Our survey summarizes the demographics and educational background of the research associates within ACRIN. This may help administrators understand the needs and characteristics of RAs participating in cooperative group research. In today’s environment with tight regulatory control, it may become necessary to improve educational standards or require certification through one of the professional research organizations.
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