Improving the use of treatment escalation plans: a quality-improvement study.

Objectives: Treatment escalation plans (TEPs) are vital in communicating a ceiling of care. However, many patients still deteriorate and die without a pre-established ceiling of care for attending clinicians to rely on. We aimed to increase the proportion of suitable patients that have TEPs in place in a rural district general hospital.

Viral safety of human plasma-derived medicinal products: impact of regulation requirements.

The viral safety of plasma-derived medicinal products is of paramount importance. This article aims to provide insight into the relative impact of different safety measures on achieving viral safety of finished products, derived from human plasma. Virus removal and/or inactivation during the production process is the most important safety measure, and model-based risk estimates show that with current safety measures, the risk of transmission of known blood-borne pathogens to plasma product recipients is extremely low.

Virus safety of plasma products using 20 nm instead of 15 nm filtration as virus removing step.

During the manufacture of human plasma derivatives, a series of complementary measures are undertaken to prevent transmission of blood-borne viruses. Virus filtration using 15 nm (Planova15N) filters has successfully been implemented in manufacturing processes for various plasma derivatives primarily because virus filtration is a technique, mild for proteins, that can effectively remove even small non-lipid-enveloped viruses, such as HAV and parvovirus B19. However, the use of 15 nm filters has limitations with regard to protein capacity of the filters and the process flow, resulting in an expensive manufacturing step.

A probabilistic model for analyzing viral risks of plasma-derived medicinal products.

Background: The prevention of transmission of viral infections by plasma-derived medicinal products is of concern to manufacturers, legislators, and patient representative groups. Recent European legislation requires a viral risk assessment for all new marketing applications of such products.

Study Design And Methods: A discrete event Monte Carlo model was developed to determine the viral transmission risks of the plasma-derived medicinal products.

A phase I/IIa study with succinylated human serum albumin (Suc-HSA), a candidate HIV-1 fusion inhibitor.

Background: Succinylated human serum albumin (Suc-HAS) is a negatively charged neo-glycoprotein that binds to the positively charged V3-loop of HIV-1 gp120, acting as HIV-1-fusion inhibitor in vitro (IC50: 0.5-5.0 microg/ml).