排序方式: 共有45条查询结果,搜索用时 78 毫秒
1.
The Annual bioProcessUK Conference has acted as the key networking event for bioprocess scientists and engineers in the UK for the past 10 years. The following article is a report from the sessions that focused on continuous bioprocessing during the 10th Annual bioProcessUK Conference (London, December 2013). These sessions were organized by the ‘EPSRC Centre for Innovative Manufacturing in Emergent Macromolecular Therapies’ hosted at University College London. A plenary lecture and workshop provided a forum for participants to debate topical issues in roundtable discussions with industry and academic experts from institutions such as Genzyme, Janssen, Novo Nordisk, Pfizer, Merck, GE Healthcare and University College London. The aim of these particular sessions was to understand better the challenges and opportunities for continuous bioprocessing in the bioprocessing sector. 相似文献
2.
3.
Sharma B 《Biotechnology advances》2007,25(3):310-317
The patents of first-generation biopharmaceutical proteins are expiring, creating opportunities for biosimilar products. Unlike conventional generic pharmaceuticals, the development of biosimilar products is far more complex and requires more than a simple demonstration of pharmacological bioequivalence to establish efficacy and safety. The main concern with biosimilar products, as for any therapeutic protein, is immunogenicity and with it the potential for serious clinical sequelae. In the absence of adequate predictors of immunogenicity outside the clinical trial setting, biosimilar products should be evaluated in the same way that any novel pharmaceutical is evaluated. Herein, the factors involved in breaking host tolerance following administration of a therapeutic protein are discussed. The impact of product handling on immunogenicity is considered in the context of some hard-fought lessons that have helped to shape the current era of biopharmaceutical manufacturing, packaging, distribution, storage, and quality assurance. 相似文献
4.
生物药物分析实验是生物药物分析理论课程的重要补充,是培养学生掌握和巩固理论知识以及实验操作技能的重要途径。为适应现代高等教育对本科生的培养要求,对生物药物分析原有单一的实验教学模式进行改革已势在必行。我学院生物药物分析实验教学改革从实验教学内容、实验教学方法、实验教学手段等方面进行实践探索,建立了"验证性-综合设计性实验教学"、"科研-实验教学相结合"、"开放式实验教学"等新型的实验教学模式,在近几年的本科实验教学活动中,对于培养学生的实际操作能力、独立分析问题和解决问题的能力,团队协作等方面的能力起到了明显的效果,受到学生好评。 相似文献
5.
Jenkins RE Kitteringham NR Hunter CL Webb S Hunt TJ Elsby R Watson RB Williams D Pennington SR Park BK 《Proteomics》2006,6(6):1934-1947
The development of a novel method for absolute quantification of proteins based on isotope-coded affinity tagging using ICAT reagents is described. The method exploits synthetic peptide standards to determine protein content at the femtomole level in biological samples. The approach is generally applicable to any subset of proteins, but is particularly appropriate for quantitative analysis of multiple, closely related isoforms, and for hydrophobic proteins that are poorly represented in 2-D gels. Relative and absolute quantification techniques are applied to an important group of microsomal metabolic enzymes, the cytochromes P450 (P450), which are critical in determining the disposition, safety and efficacy of drugs in man. Measurement of the P450 induction profile in response to chemicals is a fundamental aspect of drug safety evaluation and is currently achieved by low-throughput methods employing poorly discriminatory antibodies or substrates. Tagging technology is shown to supersede conventional methods for P450 profiling in terms of discriminatory power and throughput, exemplified by the simultaneous detection of distinct induction profiles for cyp2c subfamily members in response to phenobarbitone: cyp2c29 expression, but not cyp2c40 or cyp2c50, was induced threefold by treatment. This technology should abbreviate the drug development pathway, and provide a widely applicable, rapid means of quantifying proteins. 相似文献
6.
就当前制约我国生物医药发展的影响因素进行了全面、细致地分析,并相应地对下一步生物医药R&D的发展提出设想. 相似文献
7.
我国生物医药企业发展建议 总被引:1,自引:0,他引:1
近年来,国外生物医药产业发展迅速,在发达国家,生物医药产品在药品市场中已占有了重要地位,哺乳动物细胞表达的产品已经占据生物医药的主流地位。相比之下,我国生物医药品种主要采用简单的大肠杆菌、酵母表达技术,技术难度较高的哺乳动物细胞药品与国外差距显著,因此,哺乳动物表达的生物药品将成为国内生物医药企业的重要发展机会。多年来,鉴于我国从发达国家获得生物技术转让少,国内生物医药发展需立足于自主研发,建立高效的研发技术平台,选择合适的开发项目,促进企业的发展。 相似文献
8.
董良 《现代生物医学进展》2008,8(10):1989-1991
本文系统化的综述了当前一个热门的研发领域-疫苗工业,并详细分析了其背景和潜在的市场,以及中国疫苗工业在发展中可能遇到的机遇和挑战。此外,还对中国疫苗工业存在的某些问题提出了解决方法。只有加强中国生物技术公司在高端疫苗领域的技术水平才能在根本上与国外制药业巨头竞争一席之地,向广大民众提供更好的药物。 相似文献
9.
P. G. Varley A. J. Brown H. C. Dawkes N. R. Burns 《European biophysics journal : EBJ》1997,25(5-6):437-443
Analytical ultracentrifugation (AUC) has re-emerged as a powerful technique for protein characterisation. We report the pivotal
role sedimentation equilibrium AUC has played in the development of macrophage inflammatory protein-1α (MIP-1α) as a protein therapeutic. MIP-1α has potential clinical applications in cancer but its clinical use is limited, since it associates to form large insoluble
aggregates in physiological buffers. Using AUC as a screening technique, we have produced a biologically active variant of
MIP-1α, BB-10010, which has a reduced tendency to aggregate in physiological buffers. The aggregation of protein based pharmaceuticals
is routinely monitored by size exclusion chromatography (SEC). Comparison of the data acquired by SEC and AUC, demonstrates
that owing to the complexity of BB-10010, AUC analysis is required in addition to SEC to provide a rigorous characterisation
of molecular association. This work has been extended to include the use of AUC as an analytical tool to monitor the quality
of BB-10010 during formulation and stability studies.
Accepted: 6 October 1996 相似文献