When will we have a clone? An industry perspective on the typical CLD timeline.

Cell line development (CLD) represents a complex but highly critical process during the development of a biological drug. To shed light on this crucial workflow, a team of BioPhorum members (authors) has developed and executed surveys focused on the activities and effort involved in a typical CLD campaign. An average of 27 members from different companies that participate in the BioPhorum CLD working group answered surveys covering three distinguishable stages of a standard CLD process: (1) Pre-transfection, including vector design and construction; (2) Transfection, spanning the initial introduction of vector into cells and subsequent selection and analysis of the pools; and (3) Single Cell Cloning and Lead Clone Selection, comprising methods of isolating single cells and confirming clonal origin, subsequent expansion and screening processes, and methods for identifying and banking lead clones. The surveys were very extensive, including a total of 341 questions split between antibody and complex molecule CLD processes. In this survey review, the authors interpret and highlight responses for antibody development and, where relevant, contrast complex molecule development challenges to provide a comprehensive industry perspective on the typical time and effort required to develop a CHO production cell line.

An Insidious Case of Severe Acquired Factor VIII Inhibitor.

Acquired hemophilia occurs when neutralizing antibodies inhibit the activity of coagulation factors, commonly occurring with factor VIII. Most cases are idiopathic; however, autoimmune diseases, certain medications, and malignancies can predispose patients to the development of these inhibitors. Moreover, the initial presentation of the disease is more often catastrophic bleeding, with ecchymosis or mucosal bleeding being less common. This case report outlines an incidental finding of a severe factor VIII inhibitor (with 0% activity) with non-catastrophic bleeding at presentation in the setting of potential lymphoma. Subsequently, the patient was treated with recombinant factor VIIa and immunosuppression with steroids. The case sheds light on the benign presentation of a rapidly fatal disease, thus necessitating urgent and rapid identification. Given the insidious presentation, further research is required on the various factor inhibitors to reduce health costs and improve mortality.

Role of Tranexamic Acid in Palliative Control of Bleeding in End-Stage Head and Neck Cancer: A Case Report.

Tumor-related bleeding is a common manifestation of end-stage head and neck cancer, and it can have a significant impact on a patient's quality of life. Tranexamic acid is an anti-fibrinolytic agent that has been shown to effectively control bleeding and reduce the need for transfusions in various hemorrhagic conditions. Here, we present the case of a patient with end-stage head and neck cancer experiencing recurrent episodes of bleeding, who was able to successfully achieve hemostasis after being treated with tranexamic acid. This case report highlights the role of tranexamic acid as a palliation agent that can help control the unpleasant bleeding symptoms of end-stage head and neck cancer and provide a better quality of life for patients.

Phosphine estimation in fumigated food grains using gas chromatography equipped with FPD detector.

Phosphine, as per several reports, is considered to be an ideal and effective alternative to methyl bromide (MB) fumigant, phased out globally honouring 'Montreal Protocol'. The food grains fumigated with phosphine are perceived to be residue-free; however, estimation of its residues is imperative. In the present study, the phosphine residues were estimated in grains of wheat, rice, green gram, chickpea and yellow pea fumigated with different formulations of phosphine under 7 and 10 days exposure periods at various locations in India. For efficacy studies, the conventional aluminium phosphide (AlP) tablet (56% @2 and 3 tablet/MT) and granular AlP (77.5% @1.0 and 1.5 g phosphine/m3) formulations were applied. Each treatment including untreated control was replicated thrice. The concentration was monitored every 24 h until the end of exposure periods. Food grain samples were drawn before and post fumigation following a certain waiting period for estimation of phosphine residues using gas chromatography equipped with FPD detector. Residues in fumigated food grains were observed in traces in all the experimental stacks, but below the MRL (0.1 ppm), fixed by Codex Alimentarius Commission (CAC). Phosphine can be considered safe for use as an alternate fumigant in quarantine and long-term storage of food grains leaving residues below MRL.

First case of Arcobacter species isolated in pericardial fluid in an HIV and COVID-19 patient with worsening cardiac tamponade.

Arcobacter spp. is an emerging pathogen that is increasingly recognized as a cause of human infections. Gastrointestinal manifestations are most described in the case report literature. We present a case of the first documented case of Arcobacter spp. isolated in pericardial fluid in an immunocompromised patient with worsening cardiac tamponade that was successfully managed with an urgent pericardiocentesis and ensuing steroids, antibiotics, and a pericardial drain. The patient had a past medical history of HIV, latent syphilis, PCP pneumonia, ESRD, and hypertension, and presented with worsening dyspnea, subjective fever, myalgias, cough, pleuritic chest pain, and pericardial rub. Diagnostic workup revealed a positive COVID-19 PCR test, elevated high-sensitive cardiac troponins, elevated CRP, elevated D-dimer, and elevated creatinine. An ECG revealed diffuse ST-segment elevation, and imaging showed cardiomegaly with pulmonary vascular congestion and diffuse interstitial edema. Urgent TTE showed a large circumferential pericardial effusion with tamponade physiology present. Culture on aerobic blood agar grew Arcobacter spp. of unknown specific species, and blood cultures were also positive for Arcobacter spp. Treatment involved intravenous meropenem for five days, followed by oral ciprofloxacin, low-dose colchicine, and a tapered dose of ibuprofen. Repeat laboratory data and TTE showed complete resolution of the pericardial effusion and improved left ventricular function. This case highlights the potential for Arcobacter spp. to cause severe infections and the importance of considering it as a possible pathogen in patients with atypical presentations.

Non-Cutaneous Visceral Kaposi's Sarcoma Diagnosis Confounded by Mycobacterium Avium Complex Lymphadenitis.

Kaposi's sarcoma (KS) is an Acquired Immune Deficiency Syndrome (AIDS)-defining illness, with cutaneous KS being a more common presentation. Visceral involvement, particularly in the gastrointestinal (GI) tract, without cutaneous involvement, is rare. Consisting of generally non-specific symptoms, GI-KS can have potentially fatal outcomes, including hemorrhage or perforation, making prompt diagnosis and treatment imperative. Our case describes a 31-year-old male with AIDS who presented with a neck mass and purulent, bloody rectal drainage. The neck mass was biopsied and identified as caseated necrotic cervical lymphadenitis caused by Mycobacterium avium complex (MAC). The patient presented with rectal drainage, and additional abdominal necrotic lymph nodes were discovered on CT. A subsequent colonoscopy was completed, confirming the diagnosis of visceral KS. Delayed diagnosis of visceral KS can lead to an extensive, widespread disease requiring adjuvant and prolonged treatment. Prompt diagnosis can reduce morbidity and mortality. This case aims to shed light on a rare presentation of a common disease state with potentially fatal complications and emphasizes the importance of maintaining a broad differential diagnosis.

Experiences with Pandemic Food Access Among Clinic-Based Community Supported Agriculture Program Participants.

OBJECTIVES: The COVID-19 pandemic intensified food insecurity (FI) across the country, and families with children were disproportionately affected. This study explores experiences with FI and social resources during the pandemic among families participating in a free, clinic-based community supported agriculture (CSA) program. METHODS: Free weekly boxes of organic produce from local farms were distributed to pediatric caregivers for 12 weeks at two pediatric outpatient centers associated with a children's hospital in a low-income, urban area. Demographics and a two-question FI screen were collected. Caregivers were purposively selected to participate in semi-structured interviews about experiences with FI and community or federal nutrition programs during the pandemic. Interviews were recorded and transcribed. Content analysis with constant comparison was used to code interviews inductively and identify emerging themes. RESULTS: The 31 interviewees were predominantly female; more than half were Black, FI, and SNAP beneficiaries. Study participants were more likely to have repeat participation in the CSA program. Interviews elucidated four major themes of barriers to food access during the pandemic: (1) fluctuations in price, availability, and quality of food; (2) financial strain; (3) faster consumption with all family members home; (4) shopping challenges: infection fears, store closures, childcare. SNAP, WIC, and school meal programs were generally facilitators to food access. Increased SNAP allotments were particularly useful, and delays of mailed WIC benefits were challenging. CONCLUSIONS FOR PRACTICE: This qualitative study describes facilitators and barriers to food access among clinic-based CSA program participants during the pandemic. The findings highlight areas for further exploration and potential policy intervention.

A Case of Pernicious Anemia Presenting With Severe Hemolysis.

Vitamin B12 deficiency is a well-known and overall common disease. While the etiology of vitamin B12 deficiency varies from post-surgical changes to inadequate dietary consumption, pernicious anemia should be considered as it is a common cause. Pernicious anemia is an autoimmune atrophic gastritis impairing the absorption of vitamin B12. Manifestations include neurological changes, macrocytic anemia, glossitis, and nail changes. Hemolytic anemia is an unusual complication of vitamin B12 deficiency and an even more unusual initial presentation. This case identifies a patient with previously undiagnosed pernicious anemia with severe vitamin B12 deficiency compounded by hemolytic anemia as the presenting symptom. Overall, this case highlights the importance of considering vitamin B12 deficiency-related hemolytic anemia and the need for further research into the causes and pathophysiology of vitamin B12-induced hemolysis due to its potential for fatal outcomes despite being easily treatable with cost-effective methods to treat.

Farm to Families: Clinic-based Produce Provision to Address Food Insecurity During the Pandemic.

With rising rates of food insecurity (FI) during the pandemic, we implemented a clinic-based, community-supported agriculture program at 2 outpatient centers in low-income areas associated with an urban children's hospital and evaluated (1) the program's ability to reach FI families without preceding eligibility criteria, and (2) caregiver experiences and preferences for programming. Free boxes of produce were distributed weekly to caregivers of pediatric patients during a 12 week pilot period. Ability to reach the target population was measured by number of participating families and caregiver demographic information. We purposively sampled 31 caregivers for semistructured interviews on a rolling basis to understand program preferences. Content analysis with constant comparison was employed to code interviews inductively and identify emerging themes. Of 1472 caregivers who participated in the program, nearly half (48.3%) screened positive for FI, and 45% were receiving federal food assistance. Although many caregivers were initially "surprised" by the clinic-based program, they ultimately felt that it reinforced the hospital's commitment to "whole health" and perceived it to be safer than other food program settings during the pandemic. Several programmatic features emerged as particularly important: ease and efficiency of use, kindness of staff, and confidentiality. This advocacy case study demonstrates that a community-supported agriculture program in the clinical setting is an acceptable approach to supporting food access during the pandemic, and highlights caregiver preferences for a sustainable model. Furthermore, our data suggest that allowing families to self-select into programming may streamline operations and potentially facilitate programmatic reach to families who desire assistance.

Comparative cytopathologic evaluation using acridine orange with Papanicolaou stain in psychoactive substances abusers with potentially malignant and malignant disorders.

INTRODUCTION: Oral cancer is a major health problem and its early detection is advantageous for therapeutic purposes. According to available evidence, the risks of oral malignancies increase with the usage of tobacco and other psychoactive substances (PSs). The present study showed expression pattern of nuclear and cytoplasmic changes from normal individuals without habit to oral potentially malignant disorders (OPMD) and oral squamous cell carcinoma (OSCC) in PS abusers with the help of fluorescence acridine orange (AO) stain and Papanicolaou (PAP) stain. AIM AND OBJECTIVES: This study aimed to investigate and compare diagnostic efficacy of fluorescence microscopic evaluation of AO stain in cytological smears with PAP staining under light microscopy in PS abusers having oral potentially malignant and malignant lesions. MATERIALS AND METHODS: Oral smears from 120 individuals among which 40 from potentially malignant disorders, 40 from oral malignancy and 40 normal buccal mucosa smears were prepared. One set of smears was stained by AO staining and the other by PAP staining and examined under fluorescence and light microscope, respectively. The results of both the stainings were evaluated by grading cytology smears in class-I to class-V cytology. RESULTS: The AO fluorescence stain reliably demonstrated malignant cells based on the differential fluorescence. The efficacy of AO fluorescence stain was higher than PAP stain in screening of oral lesions suspicious of malignancy. The sensitivity of PAP staining and AO staining is 57.50% and 61.25%, respectively. CONCLUSION: As compared to PAP staining method, fluorescent AO method is more effective in screening of OPMD and OSCC in PS abusers.

Bioleaching of copper and nickel from mobile phone printed circuit board using Aspergillus fumigatus A2DS.

The recovery of metals from electronic waste was investigated by using fungal strain Aspergillus fumigatus A2DS, isolated from the mining industry wastewater. Fifty-seven percent of copper and 32% of nickel were leached (analyzed by Inductively Coupled Plasma Atomic Emission Spectroscopy (ICP-OES)) by the organism after one-step leaching at a temperature of 30 °C (shaking condition for 7 days). Maximum % of copper and nickel were obtained at a pH of 6 (58.7% Cu and 32% Ni), the temperature of 40 °C (61.8% Cu and 27.07% Ni), a pulp density of 0.5% (62% Cu and 42.37% Ni), and inoculums of 1% (58% Cu and 32.29% Ni). The XRD pattern of PCB showed 77.6% of copper containing compounds. XRD analysis of the leachate residue showed only 23.2% Euchorite (ASCu2H7O8) and 9.4% other copper containing compounds, indicating the leaching property of the fungus. HPLC analysis of the spent medium showed the presence of different acids like citric, succinic, and fumaric acid. The FTIR spectrum showed a decrease in carboxylic stretching in the leachate produced after bioleaching using spent medium. ICPOES of the leachate obtained using spent medium showed that 61% of the copper and 35% of nickel were leached out after seven days of incubation at shaking condition and 57% of copper and 32.8% of nickel at static condition confirming acidolysis property of the strain. A. fumigatus A2DS metal absorption and adsorption ability were observed using transmission electron microscopy (TEM) and scanning electron microscopy energy dispersive X-ray (SEM-EDX) respectively. The results thus indicate that bioleaching of Cu and Ni is bioleached by A. fumigatus A2DS.

Metabolic Changes in Pediatric HIV-Positive Patients and Potential Lifestyle Interventional Strategies.

Metabolic changes in the HIV population have been well-studied, particularly after the advent of antiretroviral therapy. More notably, the emergence of the metabolic syndrome within the HIV population, due to prolonged survival, has led to an increasing rate of cardiovascular occurrence and mortality within the population in adult life. Importance of early intervention in HIV children, particularly lifestyle modifications, is necessary to reduce cardiovascular disease (CVD) risk and mortality in adulthood. Potential clinical interventions include routine anthropometric measurements as a measure of CVD risk, a low saturated fat and high fiber diet, and vigorous aerobic exercise have been shown to decrease CVD risk in the HIV population. The literature review found multiple knowledge gaps due to minimal studies completed on the HIV population and even less on HIV-positive children. Overall, a standardized protocol was required to better care for HIV-positive children and potential future CVD mortality.

Effects of a trauma-informed curriculum on depression, self-efficacy, economic security, and substance use among TANF participants: Evidence from the Building Health and Wealth Network Phase II.

RATIONALE: Integrating trauma-informed peer support curriculum into the Temporary Assistance for Needy Families (TANF) program can help address caregiver trauma symptoms (e.g., depression, low self-efficacy, economic hardship) caused by exposures to violence and adversity that negatively impact one's ability to maintain employment and improve earnings; yet, it is unclear if trauma-informed peer support interventions designed for TANF impact co-occurring disorders, such as depression and substance use, that inhibit resiliency in the labor market. OBJECTIVE: The aim of this study is to examine whether integrating trauma-informed peer support curriculum into the TANF program is associated with reductions in co-occurring depression and substance use, and improvements in self-efficacy and economic security. METHOD: From October 2015 to May 2018, 369 caregivers were enrolled in the 16-week Building Wealth and Health Network Phase II single-group cohort study. Participants responded to questions regarding their socio-demographic characteristics, mental health, economic security, and use of drugs and alcohol at baseline and four three-month follow-up surveys. Associations between the trauma-informed peer support curriculum and health outcomes were assessed using maximum likelihood estimation. RESULTS: Using class attendance records, participants were separated into a low-exposure group (

Veterinarians' attitudes and practices regarding opioid-related vet shopping practices in tri-state Appalachian counties: an exploratory study.

BACKGROUND: The opioid crisis continues to grow in the United States with 46,700 drug overdose deaths due to opioids in 2017 alone. Vet shopping, the practice of soliciting veterinarians for prescription medications, has been receiving national media attention in recent years. A 2014 review of Prescription Monitoring Drug Programs found less than 10 veterinary shoppers nationwide. Still much is unknown about the role of vet shopping and the opioid crisis. This study sought to understand the practice of vet shopping through the eyes of veterinarians practicing in Appalachian counties within the states of Kentucky, Tennessee, and Virginia, United States. RESULTS: Fourteen veterinarians were asked a set of 13 questions related to vet shopping. Results indicated that 13 veterinarians in the study had heard of the phenomenon of vet shopping and eight veterinarians had personally encountered vet shopping in their practices. Qualitative analysis of the interviews identified six key themes including a need for interprofessional communication and how important a valid veterinary-client-patient-relationship is within the profession. CONCLUSIONS: The study hopefully sheds some light on the how often vet shopping is encountered in practice, concerns of veterinarians regarding vet shopping, and potential areas for improvement.

Financial health as a measurable social determinant of health.

OBJECTIVES: Financial health, understood as one's ability to manage expenses, prepare for and recover from financial shocks, have minimal debt, and ability to build wealth, underlies all facets of daily living such as securing food and paying for housing, yet there is inconsistency in measurement and definition of this critical concept. Most social determinants research and interventions focus on siloed solutions (housing, food, utilities) rather than on a root solution such as financial health. In light of the paucity of public health research on financial health, particularly among low-income populations, this study seeks to: 1) introduce the construct of financial health into the domain of public health as a useful root term that underlies other individual measures of economic hardship and 2) demonstrate through outcomes on financial, physical and mental health among low-income caregivers of young children that the construct of financial health belongs in the canon of social determinants of health. MATERIALS AND METHODS: In order to extract features of financial health relevant to overall well-being, principal components analysis were used to assess survey data on banking and personal finances among caregivers of young children who participate in public assistance. Then, a series of logistic regressions were utilized to examine the relationship between components of financial health, depression and self-rated health. RESULTS: Components aligned with other measures of financial health in the literature, and there were strong associations between financial health and health outcomes. PRACTICE IMPLICATIONS: Financial health can be conceived of and measured as a key social determinant of health.

Utilizing Multi-Theory Model in Determining Intentions to Smoking Cessation Among Smokers.

BACKGROUND: Smoking is a risk factor for lung cancers, and a myriad of other acute and chronic ailments. The purpose of this study was to predict initiation and sustenance of smoking cessation among smokers using a fourth-generation behavioral framework, multi-theory model (MTM) of health behavior change. METHODS: A convenience sample of smokers from a shopping mall in rural, Appalachian Kentucky county was invited to participate in this cross-sectional study. A 38-item, face and content validated, MTM-based survey instrument was administered to the participants. RESULTS: A total of 148 participants completed the study. The mean age of the participants was 35.53 (SD = 14.52) years. Most were male (58.1%) and Caucasian (95.9%). Participants reported smoking for an average of 16.45 (SD = 13.12) years. Participatory dialogue (ß = 0.235, P = .003) and behavioral confidence (ß = 0.305, P = .005) were significant predictors of intention for initiation for smoking cessation behavior. Emotional transformation (ß = 0.319, P = .001) was a significant predictor of intention for sustenance for smoking cessation behavior. DISCUSSION: Two of the MTM constructs for initiation and one of the MTM constructs for sustenance of change accounted for a moderate amount of variance in initiation and sustenance of smoking cessation behavior among community members in a rural, Kentucky county. MTM has utility for predicting both initiation and sustenance of smoking cessation behavior. Future interventions using MTM constructs should be developed for smoking cessation behavior change.

Trauma-informed Temporary Assistance for Needy Families (TANF): A Randomized Controlled Trial with a Two-Generation Impact.

Temporary Assistance for Needy Families (TANF) has limited success in building self-sufficiency, and rarely addresses exposure to trauma as a barrier to employment. The objective of the Building Wealth and Health Network randomized controlled trial was to test effectiveness of financial empowerment combined with trauma-informed peer support against standard TANF programming. Through the method of single-blind randomization we assigned 103 caregivers of children under age six into three groups: control (standard TANF programming), partial (28-weeks financial education), and full (same as partial with simultaneous 28-weeks of trauma-informed peer support). Participants completed baseline and follow-up surveys every 3 months over 15 months. Group response rates were equivalent throughout. With mixed effects analysis we compared post-program outcomes at months 9, 12, and 15 to baseline. We modeled the impact of amount of participation in group classes on participant outcomes. Despite high exposure to trauma and adversity results demonstrate that, compared to the other groups, caregivers in the full intervention reported improved self-efficacy and depressive symptoms, and reduced economic hardship. Unlike the intervention groups, the control group reported increased developmental risk among their children. Although the control group showed higher levels of employment, the full intervention group reported greater earnings. The partial intervention group showed little to no differences compared with the control group. We conclude that financial empowerment education with trauma-informed peer support is more effective than standard TANF programming at improving behavioral health, reducing hardship, and increasing income. Policymakers may consider adapting TANF to include trauma-informed programming.

Mothers' Adverse Childhood Experiences and Their Young Children's Development.

INTRODUCTION: This study examined how mothers' Adverse Childhood Experiences (ACEs) relate to their children's developmental risk and assessed how the association is mediated through mothers' depressive symptoms and fair/poor health. METHODS: Mothers of children aged between 4 months and 4 years were recruited from the emergency department of a children's hospital between March 2012 and June 2015 and interviewed about ACEs, mothers' depressive symptoms and health status, and children's developmental risk (screened via Parents' Evaluations of Developmental Status [PEDS]). Between August and November 2016 a Cochran-Armitage test assessed trend of PEDS by ACEs. Multinomial regression models examined differences in PEDS by ACEs severity. Mediation by mothers' depressive symptoms and self-rated health was also assessed. RESULTS: Of 1,293 mothers, 56.7% reported one or more ACEs. Mothers also reported developmental risk (20.4% overall): 120 (9.2%) reported one concern and 144 (11.2%) reported two or more concerns on the PEDS. Mothers who reported household substance use, mental illness, or an incarcerated household member during childhood were more likely to report at least one child developmental concern on the PEDS. After controlling for covariates, odds of one PEDS concern were 1.86 (95% CI=1.16, 3.00) for ACEs, one to three versus none, and 2.21 (95% CI=1.26, 3.87) for ACEs four or more versus none. Adjusted odds of two or more concerns were 1.70 (95% CI=1.07, 2.72) for ACEs, one to three versus none, and 1.76 (95% CI=1.02, 3.05) for ACEs, four or more versus none. Mothers' depressive symptoms and self-rated health were potential mediators. CONCLUSIONS: Mothers' ACEs are significantly associated with their children's developmental risk. If replicated, findings suggest that addressing intergenerational trauma through focus on childhood adversity among young children's caregivers may promote child development.

Does Employment-Related Resilience Affect the Relationship between Childhood Adversity, Community Violence, and Depression?

Depression is a barrier to employment among low-income caregivers receiving Temporary Assistance for Needy Families (TANF), and adverse childhood experiences (ACEs) and exposure to community violence (ECV) are often associated with depression. Using baseline data of 103 TANF caregivers of young children of the Building Wealth and Health Network Randomized Controlled Trial Pilot, this study investigated associations of two forms of employment-related resilience-self-efficacy and employment hope-with exposure to adversity/violence and depression, measured by the Center for Epidemiologic Studies Depression (CES-D) short form. Using contingency table analysis and regression analysis, we identified associations between ACEs and depression [OR = 1.70 (1.25-2.32), p = 0.0008] and having high levels of ECV with a 6.9-fold increased risk for depression when compared with those without ECV [OR = 6.86 (1.43-33.01), p = 0.02]. While self-efficacy and employment hope were significantly associated with depression, neither resilience factor impacted the association of ACE level and depression, whereas self-efficacy and employment hope modestly reduced the associations between ECV and depression, 13 and 16%, respectively. Results suggest that self-efficacy and employment hope may not have an impact on the strong associations between adversity, violence, and depression.