Demonstration of Physicochemical and Functional Similarity of Biosimilar Pegfilgrastim-cbqv to Pegfilgrastim.

Background: Pegfilgrastim-cbqv/CHS-1701 (UDENYCA) (hereafter referred to as pegfilgrastim-cbqv) was approved in 2018 by the US Food and Drug Administration as a biosimilar for pegfilgrastim (Neulasta) (hereafter referred to as pegfilgrastim). Both pegfilgrastim-cbqv and pegfilgrastim are conjugates of recombinant human granulocyte colony stimulating factor (r-metHuG-CSF) with a 20 kDa polyethylene glycol (PEG) indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients receiving myelosuppressive anticancer drugs. The demonstration of analytical similarity for PEG-protein conjugates presents unique challenges since both the protein and PEG attributes must be characterized.

Evaluation of an Opt-Out Protocol for Antibiotic De-Escalation in Patients With Suspected Sepsis: A Multicenter, Randomized, Controlled Trial.

Background: Sepsis guidelines recommend daily review to de-escalate or stop antibiotics in appropriate patients. This randomized, controlled trial evaluated an opt-out protocol to decrease unnecessary antibiotics in patients with suspected sepsis.

Methods: We evaluated non-intensive care adults on broad-spectrum antibiotics despite negative blood cultures at 10 US hospitals from September 2018 through May 2020.

Safety of endoscopist-directed nurse-administered balanced propofol sedation in patients with severe systemic disease (ASA class III).

Background And Aims: The safety of endoscopist-directed nurse-administered propofol sedation (EDNAPS) has been demonstrated in low-risk patients (American Society of Anesthesiologists [ASA] class I and II). There are limited data regarding the safety of EDNAPS for endoscopic procedures in ASA class III patients. The purpose of this study was to determine the safety of EDNAPS for routine outpatient endoscopy in this population.

Changes in alcohol use after the onset of spinal cord injury.

Objective: Identify the prevalence of alcohol consumption and binge drinking at time of spinal cord injury (SCI) onset, compare these rates to data from the general population, and identify changes in alcohol use at an average of 17 months post-injury.

Design: Cross sectional, mailed self-report assessment.

Setting: A specialty hospital in the southeastern United States.

Preinjury cigarette smoking among those with traumatic spinal cord injury.

Objective: Identify the prevalence of cigarette smoking at the time of spinal cord injury (SCI) onset, compare the rate of cigarette smoking to that of the general population in the same geographic area, and identify the relationship of cigarette smoking with demographic, injury, behavioral, and psychological characteristics.

Research Method: Self-report assessments were completed during inpatient rehabilitation for new SCI.

Results: The prevalence of smokers at the time of their SCI onset was 37.

Adoptive transfer of activated marrow-infiltrating lymphocytes induces measurable antitumor immunity in the bone marrow in multiple myeloma.

Successful adoptive T cell therapy (ACT) requires the ability to activate tumor-specific T cells with the ability to traffic to the tumor site and effectively kill their target as well as persist over time. We hypothesized that ACT using marrow-infiltrating lymphocytes (MILs) in multiple myeloma (MM) could impart greater antitumor immunity in that they were obtained from the tumor microenvironment. We describe the results from the first clinical trial using MILs in MM.

Stability of lyophilized sucrose formulations of an IgG1: subvisible particle formation.

Eight lyophilized formulations of a IgG1 monoclonal antibody (MAb) were prepared containing increasing levels of sucrose. In addition, three of the formulations had sorbitol added at a level of 5% w/w relative to sucrose. The samples were stored for up to 4 weeks at 40°C, which is well below the Tg.

Structure, stability, and mobility of a lyophilized IgG1 monoclonal antibody as determined using second-derivative infrared spectroscopy.

There are many aspects of stabilization of lyophilized proteins. Of these various factors, retention of native structure, having sufficient amount of stabilizer to embed the protein within an amorphous matrix, and dampening β-relaxations have been shown to be critical in optimizing protein stability during storage. In this study, an IgG1 was lyophilized with varying amounts of sucrose.

Supply chain optimization for pediatric perioperative departments.

Economic challenges compel pediatric perioperative departments to reduce nonlabor supply costs while maintaining the quality of patient care. Optimization of the supply chain introduces a framework for decision making that drives fiscally responsible decisions. The cost-effective supply chain is driven by implementing a value analysis process for product selection, being mindful of product sourcing decisions to reduce supply expense, creating logistical efficiency that will eliminate redundant processes, and managing inventory to ensure product availability.

Root Cause Analysis of Tungsten-Induced Protein Aggregation in Pre-filled Syringes.

Particles isolated from a pre-filled syringe containing a protein-based solution were identified as aggregated protein and tungsten. The origin of the tungsten was traced to the tungsten pins used in the supplier's syringe barrel forming process. A tungsten recovery study showed that the vacuum stopper placement process has a significant impact on the total amount of tungsten in solutions.

Tungsten-induced protein aggregation: solution behavior.

Tungsten has been associated with protein aggregation in prefilled syringes (PFSs). This study probed the relationship between PFSs, tungsten, visible particles, and protein aggregates. Experiments were carried out spiking solutions of two different model proteins with tungsten species obtained from the extraction of tungsten pins typically used in syringe manufacturing processes.

Detecting acute coronary syndrome in the emergency department with cardiac magnetic resonance imaging.

Background: Managing chest pain in the emergency department remains a challenge with current diagnostic strategies. We hypothesized that cardiac MRI could accurately identify patients with possible or probable acute coronary syndrome.

Methods And Results: The diagnostic performance of MRI was evaluated in a prospective study of 161 consecutive patients.

A novel Web-based graduate medical education management system including ACGME compliance algorithms.

Objective: Administration of graduate medical education programs has become more difficult as compliance with ACGME work guidelines has assumed increased importance. These guidelines have caused many changes in the resident work environment, including the emergence of complicated cross-cover arrangements. Many participating residents (each with his or her own individual scheduling requirements) usually generate these schedules.