An Interlaboratory Study to Identify Potential Visible Protein-Like Particle Standards.

Visible protein-like particle standards may improve visual inspection and/or appearance testing practices used in the biotechnology industry. They may improve assay performance resulting in better alignment and more standardized training among different companies. The National Institute of Standards and Technology (NIST) has conducted an interlaboratory study to test whether the standards under development mimic typical proteinaceous particles found in biotherapeutics and if they can be implemented during the visual inspection process.

lmplementation of the prolyl hydroxylase inhibitor Roxadustat (FG-4592) and its main metabolites into routine doping controls.

The utility of hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitors as a therapeutic means of treating patients suffering from anaemia has been demonstrated for various clinical settings. However, besides this intended use, HIF stabilizers can be the subject of misuse in amateur and elite sports due to their erythropoietic properties, as recently proven by several cases of adverse analytical findings in doping control testing. Consequently, to allow for adequate and comprehensive test methods, knowledge of the drug candidates' metabolism and analytical options enabling appropriate detection windows in sports drug testing samples (i.

Leveraging drug-utilization and external benchmarking data to drive change in prescribing behaviors.

Purpose: Improved outcomes and cost savings achieved at a large hospital through a drug utilization benchmarking and reporting initiative are described.

Summary: Using the University HealthSystem Consortium (UHC) Clinical Resource Manager (CRM) database, the University of Kansas Hospital identified nine target areas (based on Medicare Severity Diagnosis-Related Group) in which the hospital's drug-utilization practices were deemed suboptimal relative to those of other UHC member facilities with similar caseloads. The pharmacy department developed a CRM template for generating customized reports comparing the hospital's performance on various drug-utilization metrics with that of top-performing peers (i.

Photosensitizers form in histidine buffer and mediate the photodegradation of a monoclonal antibody.

Fluorescent light (FL) photodegradation of a monoclonal antibody (mAb) formulated in histidine buffer is mediated by histidine-derived photosensitizers that accumulate and greatly increase with light exposure. Histidine-derived photosensitizers are the primary mediators of Trp photooxidation. FL-photodegradation requires light exposure and is pH dependent.

Pharmacist-acquired medication histories in a university hospital emergency department.

Purpose: A study was conducted to identify discrepancies between medication histories taken by emergency department (ED) providers (physicians, nurses, and medical students) and medication histories taken by clinical pharmacists.

Methods: During a three-month period, a clinical pharmacist was assigned to the ED in a 475-bed, tertiary care teaching facility that serves as a level I trauma center. On the arrival of a patient, ED providers completed a standard assessment that included the patient's medication history.

Expression and characterization of a low molecular weight recombinant human gelatin: development of a substitute for animal-derived gelatin with superior features.

Gelatin is used as a stabilizer in several vaccines. Allergic reactions to gelatins have been reported, including anaphylaxis. These gelatins are derived from animal tissues and thus represent a potential source of contaminants that cause transmissible spongiform encephalopathies.

Recombinant collagen and gelatin for drug delivery.

The tools of recombinant protein expression are now being used to provide recombinant sources of both collagen and gelatin. The primary focus of this review is to discuss alternatives to bovine collagen for biomedical applications. Several recombinant systems have been developed for production of human sequence collagens.