Molecular Engineering and Antibody Production

分子工程和抗体生产

基本信息

批准号：
7728851
负责人：
Robert M Sharkey
金额：
$ 6.83万
依托单位：
CTR FOR MOLECULAR MEDICINE/IMMUNOLOGY
依托单位国家：
美国
项目类别：
财政年份：
2008
资助国家：
美国
起止时间：
2008-08-01 至 2009-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7728851
关键词：
18 year old Antibodies Antibody Formation Area Ascites Binding Bispecific Antibodies Boxing Budgets CD20 Antigens CD22 gene Carbon Dioxide Cells Certification Charge Chromatography Class Clinical Clinical Research Condition Core Facility Cultured Cells DOTA-biotin Deferoxamine Development Developmental Therapeutics Program Documentation Engineering Ensure Environment Epratuzumab Equipment Fermentation Freeze Drying Funding Glass Glycine Guanosine Monophosphate High Pressure Liquid Chromatography Histamine Housing Human Resources Hybridomas Immunoelectrophoresis Immunoglobulin G Incubators Institution Iron binding capacity measurement Keyhole Limpet Hemocyanin Laboratories Laboratory Research Learning MS4A1 gene Mammalian Cell Methotrexate Molecular Monoclonal Antibodies Multiple Myeloma Mus New Brunswick Non-Hodgkin&apos s Lymphoma Participant Pentetic Acid Peptides Peroxidase Peroxidases Pharmacologic Substance Phase I Clinical Trials Pichia Preparation Procedures Process Product Labeling Production Property Pump Purpose Pyrogens Reagent Recombinants Research Research Personnel Rest Roller Bottle Standards of Weights and Measures System Testing Time Training Ultrafiltration Work Writing air filter antibody conjugate antibody engineering base cell growth cost experience foot pressure programs research study size tissue culture

项目摘要

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.

该核心的主要目的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年中一直运行，生产研究和临床用途。该核心具有产生和纯化杂交瘤抗体量的能力细胞在组织培养中生长。它在GLP条件下以100,000级工作区域运行所有纯产品的程序和完整文档。该实验室还准备抗体的缀合物，例如DTP A，DOTA，生物素，过氧化物酶，KLH以及其他用于多种目的的其他。在过去一年，CMMI与IBC Pharmaceuticals，Inc。合作开发和生产重组双特异性抗体（BSMAB）。该实验室目前经营小型发酵罐，并且已经参与E. coll和Pichia中的抗体生产。最近，这些相同的BSMAB结构已经在哺乳动物细胞中表达，因此可以在现有的GMP细胞中更容易地制造它们文化设施。对于该计划项目，该实验室将参与生产非霍奇金的抗体淋巴瘤和多发性骨髓瘤，包括对CD20，CD22和CD74的人源化抗体。化学共轭的双特异性抗体以及DOTA，DTPA，而不是A和脱氟胺偶联物将是准备研究。使用A将制备两种新的重组双特异性抗体人源化抗CD20和人源化抗HSG（组胺 - 辛基 - 甘氨酸）抗体。其中之一克隆将开发和生产供临床使用。