Multi-attribute Raman spectroscopy (MARS) for monitoring product quality attributes in formulated monoclonal antibody therapeutics.

Rapid release of biopharmaceutical products enables a more efficient drug manufacturing process. Multi-attribute methods that target several product quality attributes (PQAs) at one time are an essential pillar of the rapid-release strategy. The novel, high-throughput, and nondestructive multi-attribute Raman spectroscopy (MARS) method combines Raman spectroscopy, design of experiments, and multivariate data analysis (MVDA).

Fc galactosylation follows consecutive reaction kinetics and enhances immunoglobulin G hexamerization for complement activation.

Fc galactosylation is a critical quality attribute for anti-tumor recombinant immunoglobulin G (IgG)-based monoclonal antibody (mAb) therapeutics with complement-dependent cytotoxicity (CDC) as the mechanism of action. Although the correlation between galactosylation and CDC has been known, the underlying structure-function relationship is unclear. Heterogeneity of the Fc N-glycosylation produced by Chinese hamster ovary (CHO) cell culture biomanufacturing process leads to variable CDC potency.

Upper extremity and craniofacial vascularized composite allotransplantation: ethics and immunosuppression.

Vascularized composite allotransplantation (VCA) is the name most often used to refer to the transplantation of anatomical units composed of multiple tissue types (skin, bone, muscle, tendon, nerves, vessels, etc.) when such transplants do not have the primary purpose of extending life, as is the case in the more familiar field of solid organ transplantation (SOT). A serious interest in VCA developed in the late twentieth century following advances in immunosuppression which had led to significant improvements in short and medium-term survival among SOT recipients.

Existing and Evolving Bioethical Dilemmas, Challenges, and Controversies in Vascularized Composite Allotransplantation: An International Perspective From the Brocher Bioethics Working Group.

Early results of hand and face transplants and other grafts such as those of uterus, penis, trachea, larynx, or abdominal wall have confirmed the potential for vascularized composite allotransplantation (VCA) to restore appearance, anatomy, function, independence, and social integration in patients suffering from devastating tissue deficits untreatable by conventional treatment options. Despite such promise, these novel and complex procedures face challenges and controversies that remain open to discussion and debate. Indeed, many barriers to clinical advancement and negative stakeholder perceptions still exist.

Millicharged Particles in Neutrino Experiments.

We set constraints and future sensitivity projections on millicharged particles (MCPs) based on electron scattering data in numerous neutrino experiments, starting with MiniBooNE and the Liquid Scintillator Neutrino Detector (LSND). Both experiments are found to provide new (and leading) constraints in certain MCP mass windows: 5-35 MeV for LSND and 100-180 MeV for MiniBooNE. Furthermore, we provide projections for the ongoing Fermilab SBN program, the Deep Underground Neutrino Experiment (DUNE), and the proposed Search for Hidden Particles (SHIP) experiment.

Ethical Considerations of Whole-Eye Transplantation.

Whole eye transplantation (WET) remains experimental. Long presumed impossible, recent scientific advances regarding WET suggest that it may become a clinical reality. However, the ethical implications of WET as an experimental therapeutic strategy remain largely unexplored.

Quality in ethics consultations.

There is an increasing need for quality in ethics consultations, though there have been significant achievements in the United States and Europe. However, fundamental concerns that place the profession in jeopardy are discussed from the perspective of the U.S.

Board oversight of community benefit: an ethical imperative.

Board oversight of community benefit responsibility in tax-exempt organizations in the nonprofit health care sector is attracting considerable attention. Scrutiny by the IRS and other official bodies has led to stricter measures of compliance with the community benefit standard. But stricter compliance does not sufficiently engage the underlying ethical imperative for boards to provide effective oversight--an imperative that recent research suggests has not been sufficiently honored.

Ontological and ethical implications of direct nuclear reprogramming.

Scientific breakthroughs rarely yield the potential to engage a foundational ethical question. Recent studies on direct reprogramming of human skin cells reported by the Yamanaka lab in Japan and the Thomson lab in Wisconsin suggest that scientists may have crossed both a scientific and an ethical threshold. The fascinating science of direct nuclear reprogramming highlights empirical data that may clarify the ontological status of cellular activity in the early stages of what could become a human fetus and justify ethical options for research in this controversial field.

The process of ethical decision making.

This chapter discusses a framework for and process of ethical decision making in the context of the discipline, theories, and principles of ethics. Daily decision making within the Hospital Ethics Committee is considered and some of the emerging ethical issues in anaesthesia are discussed.

Ethical perspectives on life sciences research after mapping the human genome.

The essay discusses ethical perspectives of life sciences research that can help us navigate a path across the genetic landscape that opens before us with the map of the human genome that was announced recently. We can rightly anticipate many drug discoveries and genetic therapies to cure, prevent, or alleviate devastating conditions. But we must also pause with appropriate apprehension about the possible dangers and difficulties we may encounter.

Organizational ethics in Catholic health care: honoring stewardship and the work environment.

Organizational ethics refers to the integration of values into decision making, policies, and behavior throughout the multi-disciplinary environment of a health care organization. Based upon Catholic social ethics, stewardship is at the heart of organizational ethics in health care in this sense: stewardship provides the hermeneutic filter that enables basic ethical principles to be realized practically, within the context of the Catholic theology of work, to concerns in health care. This general argument can shed light on the specific topic of non-executive compensation programs as an illustration of organizational ethics in health care.

Biological study of R24 mouse monoclonal antibody in patients undergoing thoracotomy for pulmonary metastases from soft tissue sarcoma.

The disialoganglioside GD3 is expressed on the surface of soft tissue sarcoma, malignant melanoma, and other malignant cells and is, therefore, a potential target for therapeutic monoclonal antibodies. Intravenously administered R24, a murine IgG3 monoclonal antibody to GD3, induces inflammation and tumor regression at sites of metastatic malignant melanoma. R24 5 mg/m2 was given intravenously every other day for six doses to 10 patients with pulmonary metastases from a primary soft tissue sarcoma of the extremity for whom thoracotomy was planned.