SBIR Phase II: Novel Method for Class Switching IgM Secretors to IgG

这个小企业创新研究（SBIR）II期项目提议开发一种快速IgSwitch检测试剂盒，用于使用体外培养条件、微囊化技术和荧光激活细胞分选从IgM杂交瘤中诱导和分离IgG类别转换变体。预期IgSwitch测定是对用于分离类别转换变体的常规方法的显著改进，并且将可用于细胞系开发和单克隆抗体生产。先前的I期研究已经证明了使用模型IgM杂交瘤的所提出的方法的可行性。该II期项目将开发促进转换为不同IgG亚类的体外培养条件。II期研究还将验证一系列同种型特异性IgSwitch检测试剂。该项目的商业应用将在单克隆抗体领域。在单克隆抗体生产中使用靶向IgSwitch检测将有助于从大量未开发的IgM杂交瘤来源中产生新的IgG特异性抗体，用于潜在的研究、治疗、诊断和成像试剂。

This Small Business Innovation Research (SBIR) Phase II project proposes to develop a rapid IgSwitch Assay for inducing and isolating IgG class switch variants from IgM hybridomas using in-vitro culture conditions, microencapsulation technology and fluorescence activated cell sorting. The IgSwitch Assay is expected to be a significant improvement over conventional methods used to isolate class switch variants, and will be useful in cell line development and monoclonal antibody production. Prior Phase I research has already demonstrated the feasibility of the proposed method using a model IgM hybridoma. This Phase II project will develop in-vitro culture conditions that promote switching to different IgG subclasses. The Phase II research will also validate reagents for a family of isotype specific IgSwitch Assays. The commercial application of this project will be in the area of monoclonal antibodies. Use of the targeted IgSwitch Assay in monoclonal antibody production will help to generate new IgG specific antibodies from a largely untapped source of IgM hybridomas, for potential use as research, therapeutic, diagnostic, and imaging reagents.