Evaluating your product beyond standard characterization can provide a comprehensive understanding of a molecule in early phase development. Allan Watkinson, PhD, Director of Biopharmaceutical Development CMC at Covance, recently discussed a few of the assays that can help drug development sponsors gain new insights about their product and making earlier …
生物学的生物分析:了解LC-MS的作用
随着基于生物学的疗法扩展,LC-MS越来越多地应用于支持定量生物分析以检测不同的肽和蛋白质。与配体结合测定(LBA)的传统方法相比,LC-MS可以提供一些显着的优点,但通常被认为是互补方法。
用于宿主细胞蛋白质的抗体试剂:经验计数
通过使用源自细菌,哺乳动物,酵母,植物或昆虫细胞的各种宿主细胞表达系统,通过重组DNA技术产生大多数Biotheraptics。在涉及病毒载体的基因治疗产品的情况下,空和部分组装的病毒衣壳是产物相关的杂质,可以产生重大影响......
IND-enabling Programs for Gene and Cell Therapies Webinar Questions
Get insightful answers to some common questions on IND-enabling studies for cell and gene therapies (CGTs) from a recent Covance presentation. For more information on Covance solutions, visit our Cell & Gene Therapy Education Center here.
The importance of bees in crop pollination
普拉纳州保护是目前的热门话题,当之无愧地。为了养活77亿人口的全球人口,我们必须控制损害食物作物的不必要的害虫,而不会杀死有助于生产食物的昆虫;这主要是指蜜蜂。各种索赔被声称为......
分散临床试验(DCT)每月博客 - 11月2020年11月
Welcome to the November 2020 edition of the Covance DCT blog. The current discussions around the clinical trial industry are heavily weighted around Decentralized Trials (DCT) and how COVID19 has been a catalyst. This has heighted the awareness across our industry as we are finding many new technology companies entering this …
Biological characterization of mAbs: target binding – importance and characterization
展示生物制药的效力对于毒品的成功发展和市场释放至关重要。对于治疗性抗体,与靶抗原的结合是其作用机制的第一步,因此是该产品的关键质量属性(CQA)。由于效力测定......
What is an Inhalation reprotoxicology study – insights, advice, and secrets
什么是吸入的再定毒理学,何时相关?当怀疑有可能导致生殖或发育毒性的有可能导致生殖或发育毒性的潜在潜力并且有可能通过呼吸系统发生,需要吸入进行再陶器学研究。
免疫组织化学免疫蛋白酶型:Interpecies考虑因素影响您的非纯期研究的成功
Immunohistochemistry (IHC) is a useful tool for immunophenotyping because it enables the visualization of immune system cells in context of their tissue environment. This post examines IHC in relation to other immunophenotyping tools and highlights the challenges of interspecies interpretation of IHC from toxicological pathology during early drug or preclinical …
Covid-19大流行和超越汽车T临床试验中医学监测的关键考虑因素
以下博客是在2020年9月2020年9月的COVANCE调整的适应,这里还在这里重新录制和提供背景:医学监测支持正确测定汽车T细胞疗法的患者资格,并在监测质量患者中发挥关键作用护理整个汽车T临床......