A Comprehensive Unit-based Safety Program to Improve Perioperative Efficiency in Adolescent Idiopathic Scoliosis.

BACKGROUND: Addressing operational inefficiencies in operating rooms (ORs) enhances patient access to care, reduces delays, and improves employee and patient satisfaction. The Comprehensive Unit-based Safety Program (CUSP) promotes patient safety through increased teamwork, empowerment of frontline staff, and utilization of science of safety principles. CUSP has demonstrated success in outpatient and inpatient settings to decrease complication rates and establish a culture of safety but has been used minimally in the perioperative setting. In this study, the CUSP methodology was utilized to improve perioperative efficiency in pediatric spine surgery, and preimplementation and postimplementation efficiency were compared, using the rate of first case on-time starts (FCOTS) as the primary metric. METHODS: A CUSP quality improvement workgroup including nurses, technicians, surgeons, anesthesiologists, and administrators sought feedback on opportunities for improvement and tracked key performance metrics in the OR from 2015 to 2020. Key interventions developed in response to feedback included standardizing and streamlining room setup and adjusting staffing models for greater efficiency. Univariate analysis was conducted to compare time periods pre-CUSP and post-CUSP implementation. RESULTS: First case on-time starts increased from 38% to a high of 81% after implementation. For more complex cases, the average patient in the room to anesthesia ready time improved by 31% with decreased variance over time, and average closure to patient out of room time improved by 45%. Improvements were sustained through Year 3, while CUSP remained a primary focus for the team. CONCLUSIONS: CUSP is effective in enhancing perioperative efficiency, demonstrating strong improvement in on-time starts over 5 years. The results indicate that process improvement in ORs requires consistent attention to sustain gains over time. Engaging frontline staff in quality improvement fosters collaboration and provides employee buy-in to promoting a culture of safety and improving value in patient care. LEVEL OF EVIDENCE: Level III-retrospective comparative study.

Affinity chromatography: A versatile technique for antibody purification.

Antibodies continue to be extremely utilized entities in myriad applications including basic research, imaging, targeted delivery, chromatography, diagnostics, and therapeutics. At production stage, antibodies are generally present in complex matrices and most of their intended applications necessitate purification. Antibody purification has always been a major bottleneck in downstream processing of antibodies, due to the need of high quality products and associated high costs. Over the years, extensive research has focused on finding better purification methodologies to overcome this holdup. Among a plethora of different techniques, affinity chromatography is one of the most selective, rapid and easy method for antibody purification. This review aims to provide a detailed overview on affinity chromatography and the components involved in purification. An array of support matrices along with various classes of affinity ligands detailing their underlying working principles, together with the advantages and limitations of each system in purifying different types of antibodies, accompanying recent developments and important practical methodological considerations to optimize purification procedure are discussed.

Optimizing antibody expression: The nuts and bolts.

Antibodies are extensively utilized entities in biomedical research, and in the development of diagnostics and therapeutics. Many of these applications require high amounts of antibodies. However, meeting this ever-increasing demand of antibodies in the global market is one of the outstanding challenges. The need to maintain a balance between demand and supply of antibodies has led the researchers to discover better means and methods for optimizing their expression. These strategies aim to increase the volumetric productivity of the antibodies along with the reduction of associated manufacturing costs. Recent years have witnessed major advances in recombinant protein technology, owing to the introduction of novel cloning strategies, gene manipulation techniques, and an array of cell and vector engineering techniques, together with the progress in fermentation technologies. These innovations were also highly beneficial for antibody expression. Antibody expression depends upon the complex interplay of multiple factors that may require fine tuning at diverse levels to achieve maximum yields. However, each antibody is unique and requires individual consideration and customization for optimizing the associated expression parameters. This review provides a comprehensive overview of several state-of-the-art approaches, such as host selection, strain engineering, codon optimization, gene optimization, vector modification and process optimization that are deemed suitable for enhancing antibody expression.

Affinity chromatography as a tool for antibody purification.

The global antibody market has grown exponentially due to increasing applications in research, diagnostics and therapy. Antibodies are present in complex matrices (e.g. serum, milk, egg yolk, fermentation broth or plant-derived extracts). This has led to the need for development of novel platforms for purification of large quantities of antibody with defined clinical and performance requirements. However, the choice of method is strictly limited by the manufacturing cost and the quality of the end product required. Affinity chromatography is one of the most extensively used methods for antibody purification, due to its high selectivity and rapidity. Its effectiveness is largely based on the binding characteristics of the required antibody and the ligand used for antibody capture. The approaches used for antibody purification are critically examined with the aim of providing the reader with the principles and practical insights required to understand the intricacies of the procedures. Affinity support matrices and ligands for affinity chromatography are discussed, including their relevant underlying principles of use, their potential value and their performance in purifying different types of antibodies, along with a list of commercially available alternatives. Furthermore, the principal factors influencing purification procedures at various stages are highlighted. Practical considerations for development and/or optimizations of efficient antibody-purification protocols are suggested.

Variability in stable sagittal vertebra (SSV) during full-length biplanar xrays can affect the choice of fusion levels in patients with adolescent idiopathic scoliosis (AIS).

PURPOSE: Surgical planning for Adolescent Idiopathic Scoliosis (AIS) relies on the coronal and sagittal plane to determine the lowest instrumented vertebra (LIV). Failure to include the stable sagittal vertebra (SSV) within the construct can increase the incidence of postoperative distal junctional kyphosis (DJK). The purpose of this study is to assess the variability of SSV within patients and to identify positional parameters that may lead to its change. METHODS: This is a case-control study of AIS patients with changes in SSV throughout serial radiographs. Radiographic sagittal parameters and hand positioning for the patients with changes in SSV were compared to patients with stable SSV. Additionally, a subgroup analysis was conducted to compare the positional parameters of only the patients with changes in SSV. RESULTS: 46 patients with a mean age of 15 ± 1.8 years old at the time of surgery were included in this study. 33/76 (43.4%) image pairs were found to have a change in SSV. Positional parameters associated with the more distally measured SSV were found to have a more negative sagittal vertebral axis (p = 0.001), more positive pelvic shift (p = 0.023), and more negative Global Sagittal Axis (p = 0.001) when compared to the more proximally measured SSV. CONCLUSION: Significant variability exists in the determination of SSV in AIS patients undergoing serial radiographs. Positional parameters associated with the proximal and distally measured SSV also have variability which indicates that posture has a significant impact on this measure. Surgeons need to be aware of SSV variability during preoperative planning and must consider multiple parameters for the determination of LIV. LEVEL OF EVIDENCE: 3.

Optimum Detection of Ureaplasma in Premature Infants.

BACKGROUND: Ureaplasma spp. is a known risk factor for bronchopulmonary dysplasia in premature infants. Emerging research suggests treatment with azithromycin or clarithromycin in the first days of life (DOLs) reduces bronchopulmonary dysplasia in Ureaplasma spp. positive infants. Side effects of these antibiotics make it imperative to optimize reliable noninvasive screening procedures to identify infants who would benefit from treatment. METHODS: The aim of this study was to determine the best site and time to screen for Ureaplasma spp. in 24- to 34-week premature infants. Oral, nasal, gastric and tracheal cultures were collected and placed immediately in 10B broth media. Polymerase chain reaction verified culture results and identified the Ureaplasma spp. RESULTS: Cultures yielded a Ureaplasma spp. incidence of 80/168 = 47.6% [95% confidence interval (CI): 40-56]. Nasal cultures had greater sensitivity to detect Ureaplasma spp. than oral cultures (P = 0.008): however, a significant proportion of infants with Ureaplasma spp. would have been missed (12/79 = 15.2%, 95% CI: 8%-25%, P < 0.001) if oral cultures were not obtained. For all sites, the collection at DOL 7-10 were more likely to be positive than the collection at DOL 1-2: however, a significant proportion (5/77 = 6.5%, 95% CI: 2-15, P < 0.001) of infants with Ureaplasma spp. would have been missed if the DOL 1-2 cultures were not obtained. CONCLUSIONS: For optimal Ureaplasma spp. detection in 24- to 34-week premature infants, cultures need to be taken both early and late in the first 10 DOLs both from nasal and oral secretions.

Coming-of-Age of Antibodies in Cancer Therapeutics.

Antibody-based therapies have garnered considerable success in recent years. This is due to the availability of strategies to successfully engineer antibodies into humanized forms, better understanding of the biological processes involved in cancer development, the availability of novel recombinant antibody formats, better antibody selection platforms, and improved antibody conjugation methodologies. Such achievements have led to an explosion in the generation of antibodies and antibody-associated constructs for the treatment of cancer and other diseases. In this review, we critically assess recent trends in the development and applications of bispecific antibodies (bsAbs), antibody-drug conjugates (ADCs), and immune checkpoint inhibitors (ICIs) as cancer therapeutics. We also highlight recent US FDA approvals and clinical trials of antibody-based cancer therapies.

Affinity chromatography for antibody purification.

The availability of purified antibodies is prerequisite for many applications and the appropriate choice(s) of antibody-purification steps is crucial. Numerous methods have been developed for the purification of antibodies; however, affinity chromatography-based methods are the most extensively utilized. These methods are based on highly specific and reversible biological interactions between two molecules (e.g., between receptor and ligand or antibody and antigen). Affinity chromatography offers very high selectivity, involving minimal steps, providing simplicity of approach and rapidity. Implementing an effective protocol often requires meticulous planning and testing in order to achieve high purity and yields of desired antibody types/subtypes. This chapter describes the basic techniques for purification of monoclonal, polyclonal, and recombinant antibodies employing affinity chromatography.

Generation of an anti-NAGase single chain antibody and its application in a biosensor-based assay for the detection of NAGase in milk.

Bovine mastitis, an inflammation of the mammary gland in cows, is a major challenge for the dairy industry worldwide as it lowers milk yield, reduces milk quality and increases overall production costs. Early diagnosis is of the utmost importance. N-acetyl-ß-D-glucosaminidase (NAGase) is an enzyme released into milk during inflammation and acts as an early indicator of mastitis. This paper describes the selection of anti-NAGase single chain fragment variable antibodies (scFv) from naïve human antibody libraries and their incorporation into an automated optical biosensor-based immunoassay to detect NAGase in milk. The scFv with the highest affinity for NAGase was first characterized by inhibition ELISA, followed by further evaluation using a surface plasmon resonance platform. Purified NAGase was immobilized on the surface of a CM5 chip and spiked NAGase milk samples were analyzed. The limit of detection for the assay for the assay was determined as 1µg/ml.

Mastitis detection: current trends and future perspectives.

Bovine mastitis, the most significant disease of dairy herds, has huge effects on farm economics due to reduction in milk production and treatment costs. Traditionally, methods of detection have included estimation of somatic cell counts, an indication of inflammation, measurement of biomarkers associated with the onset of the disease (e.g. the enzymes N-acetyl-beta-D-glucosaminidase and lactate dehydrogenase) and identification of the causative microorganisms, which often involves culturing methods. These methods have their limitations and there is a need for new rapid, sensitive and reliable assays. Recently, significant advances in the identification of nucleic acid markers and other novel biomarkers and the development of sensor-based platforms have taken place. These novel strategies have shown promise, and their advantages over the conventional tests are discussed.

WITHDRAWN: Genomic evidence of porcine parvovirus (ppv) in native Indian swine.

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