Molecular Engineering and Antibody Production

这个核心的主要目标是为该计划项目的参与者提供抗体试剂。 CMMI的抗体生产核心在过去20年里一直在生产抗体，用于研究和 临床应用。该核心具有从杂交瘤中生产和纯化克量抗体的能力。 在组织培养中生长的细胞。它在GLP条件下在100,000级工作区域内运行，并具有书面 所有净化产品的程序和完整文件。这个实验室还制备抗体的结合物， 例如DTP A、DOTA、生物素、过氧化物酶、KLH和其他用于各种目的的物质。超过了 在过去的一年里，CMMI与IBC制药公司合作开发和生产重组 双特异性抗体(BsMAb)。该实验室目前运行的是一个小型发酵罐， 参与了大肠杆菌和毕赤酵母中抗体的产生。最近，这些相同的bsMAb构造 在哺乳动物细胞中表达，因此可以更容易地在现有的GMP细胞中制造 文化设施。 在这个计划项目中，这个实验室将参与生产非霍奇金病的抗体 淋巴瘤和多发性骨髓瘤，包括CD20、CD22和CD74的人源化抗体。化学上 结合的双特异性抗体以及DOTA、DTPA、NOT A和去铁胺的结合物将 为研究研究做好准备。两种新的重组双特异性抗体将用一种 人源化抗CD20和人源化抗HSG(组胺-琥珀酰甘氨酸)抗体。这其中的一个 克隆人将被开发和生产用于临床。

The primary objective of this core is to provide antibody reagents for participants in this program project. CMMI's Antibody Production Core has operated for the past 20 years producing antibodies for research and clinical use. This core has the ability to produce and purify gram quantities of antibody from hybridoma cells growing in tissue culture. It operates in a Class 100,000 work area under GLP conditions with written procedures and full documentation of all purified products. This lab also prepares conjugates of antibodies, such as DTP A, DOTA, biotin, peroxidase, KLH, and others that are used for a variety of purposes. Over the past year, CMMI has collaborated with IBC Pharmaceuticals, Inc. to develop and produce recombinant bispecific antibodies (bsMAb). The laboratory currently operates a small-scale fermenter and has been, involved in the production of antibodies in E. coll and Pichia. More recently, these same bsMAb constructs have been expressed in mammalian cells so that they can be manufactured more easily in existing GMP cell culture facilities. For this Program Project, this laboratory will be involved in the production of antibodies to non-Hodgkin's lymphoma and multiple myeloma, including humanized antibodies to CD20, CD22, and CD74. Chemically conjugated bispecific antibodies, as well as DOTA, DTPA, NOT A, and deferoxamine conjugates will be prepared for research studies. Two newly recombinant bispecific antibodies will be prepared using a humanized anti-CD20 and a humanized anti-HSG (histamine-succinyl-glycine) antibody. One of these clones will be developed and produced for clinical use.