Physiochemical and functional evaluation of the first-in-class anti-cancer IgE antibody drug, MOv18, through process development and good manufacturing practice production.

Antibodies used for cancer therapy are monoclonal IgGs, but tumor-targeting IgE antibodies have shown enhanced effector cell potency against cancer in preclinical models. Research-grade recombinant IgE antibodies have been generated and studied for several decades. The recent Phase 1 clinical trial of the first-in-class MOv18 IgE, however, necessitated the inaugural process development and scaled manufacture of a recombinant IgE to clinical quality standards.

Governance of Indigenous data in open earth systems science.

In the age of big data and open science, what processes are needed to follow open science protocols while upholding Indigenous Peoples' rights? The Earth Data Relations Working Group (EDRWG), convened to address this question and envision a research landscape that acknowledges the legacy of extractive practices and embraces new norms across Earth science institutions and open science research. Using the National Ecological Observatory Network (NEON) as an example, the EDRWG recommends actions, applicable across all phases of the data lifecycle, that recognize the sovereign rights of Indigenous Peoples and support better research across all Earth Sciences.

Detecting mtDNA effects with an Extended Pedigree Model: An Analysis of Statistical Power and Estimation Bias.

Mitochondrial DNA (mtDNA) plays a crucial role in numerous cellular processes, yet its impact on human behavior remains underexplored. The current paper proposes a novel covariance structure model with seven parameters to specifically isolate and quantify mtDNA effects on human behavior. This approach uses extended pedigrees to obtain estimates of mtDNA variance while controlling for other genetic and environmental influences.

The UN Declaration on the Rights of Indigenous Peoples and Genomics: Ethical Complementarity for Just Research.

Governance of biomedical research in the United States has been characterized by ethical individualism, a mode of reasoning that treats the individual person as the center of moral concern and analysis. However, genomics research raises ethics issues that uniquely affect certain genetically related communities as collectives, not merely as aggregates of individuals. This is especially true of identifiable populations-including Indigenous Peoples-that are often minoritized, socially marginalized, or geographically isolated.