Development of an ELISA based bridging assay as a surrogate measure of ADCC 热度: 抗体效价的Elisa测定 热度: Development of a robust reporter-based ADCC assay with frozen, thaw-and-use cells to measure Fc effector function of therapeutic antibodies ...
White Paper: Potency assay development for cellular therapy products: an ISCT review of the requirements and experiences in the industry. Cytotherapy. 2013;15:9e19.Bravery CA, Carmen J, Fong T, et al. Potency assay development for cellular therapy products: an ISCT review of the requirements ...
Gene Therapy Development Improved Gene Therapy Development Develop better gene therapies with added accuracy, efficiency, and consistency from viral vector characterization to potency assay development. Explore Gene Therapy Development Viral Titer Determination Get the speed and certainty of absolute vir...
We have previously shown that intracardiac delivery of autologous CD34+ cells after acute myocardial infarction (AMI) is safe and leads to long term improvement. We are now conducting a multicenter, randomized, controlled Phase I/IIb study in post-AMI to
The partnership between CDMOs and emerging biotech companies in early-stage development can be... Webinar (on-demand) Integrating a High Sensitivity Immunopeptidomics (MAPPs) Assay in Preclinical Immunogenicity Risk... Immunogenicity poses a critical risk to all biologics, including monoclonal antibodie...
Development-of-a-cell-based-potency-assay-for-release-and-stabilit_2018_Toxi 下载积分: 300 内容提示: binding sites. VHHs are re-engineered for expression as multimers, usuallyfused with other peptides for additional properties. VHHs and VHH mul-timers are then produced as proteins or encoded ...
Principal of potency assay development for cell and gene therapy products Although in vitro potency assays have been used in small molecule and monoclonal antibody drug development for more than a decade, applications in cell and gene therapy (CGT) product development are more recent. CGT products ...
By their nature, TE/RM therapeutics pose inherently unique challenges for potency assay development and implementation. These challenges include the heterogeneous nature of both the sourcing material (typically human tissues or organs from allogeneic or autologous donors) and the product itself, the ...
Hemgenix: An Assay Development Case Study Hemgenix is a recombinant AAV serotype 5 (AAV5) based in vivo gene therapy drug indicated for the treatment of adult patients with hemophilia B (congenital factor IX deficiency) to significantly reduce the frequency of bleeding episodes and factor IX ...
There are at least two levels of challenge with the development of a multiplexed potency assay for a DP that contains either a cocktail of multiple mRNA constructs encoding multiple proteins of variant strains or a single chimeric construct encoding these antigens44. First, in a multivalent vaccine...