A Novel Interprofessional Approach to Inpatient Ready to Feed Infant Formula Management Throughout a National Supply Chain Crisis

Background: Institutions across the country are experiencing delays in receipt of essential infant formula and feeding supplies due to a supply chain crisis. The supply chain crisis commenced during the COVID-19 pandemic and has continued into present day, late 2022. The supply chain crisis led to an unstable supply of ready to feed (RTF) infant formulas for a children's hospital within a medical center containing a neonatal ICU, pediatric ICU, pediatric floor and newborn nursery. RTF formulas are the recommended inpatient infant feeding due to their sterility. Method(s): To address these RTF formula supply challenges, interprofessional leadership from Clinical Nutrition, Nursing and Supply Chain developed a local infant formula committee. The committee convened based on the needs of the institution, ranging from daily to weekly beginning October 2021 to present day. A shared, live spreadsheet allowed for real time inventory of RTF formula on the Nursing units and amount of product pending receipt in supply chain. Upon identification of low RTF supply, increased usage or RTF outage, the committee implemented a three-tiered action plan for each unit. For the first tier, the formula roomdiluted a higher calorie RTF liquid with water to the desired calorie density (example RTF 24 to RTF 20 calorie/oz). The medical team had an infant formula substitution list to guide feeding alternatives for specialty preparations. In the second tier, the formula room prepared stock formula for each unit daily, with a 24-hour expiration time, to accommodate potential for rapid census changes outside of the formula room operation. As a third layer of safety, powder emergency stock was pre-measured and sent with instructions for Nursing to reconstitute with sterile water, in a dedicated space, if all stock RTF formula was used. The powder emergency stock expired in 30 days, which allowed for a longer shelf life than the stock RTF formula. Result(s): It is practical for institutions without a formula room to implement similar processes using dedicated infant formula preparation space and storage. It also worth mentioning during this time there was a national shortage of powdered infant formulas due to a recall issued in May of 2022 by a major formula manufacturer. The national shortage included elemental powdered formulas for which there is no RTF alternative. Management of elemental formula outages were managed on a case-by-case basis by the Clinical Nutrition department. The Committee also convened to discuss allocations and identify substitutions for other neonatal and pediatric specialty items including sterile water, feeding preparation bottles, ENFit syringes and syringe caps, breastmilk collection containers and infant feeding nipples. Conclusion(s): Using this three-tiered process, the medical center provided sterile RTF formula to infants when available, remained consistent with best practices, predicted inventory needs consistent with usage and prevented waste of powdered infant formula in a time of scarcity. Technology and the anticipatory interprofessional leadership using a three-tiered action plan equipped the medical center for this most extraordinary infant formula crisis nationally.

Development of research use only specific IgE immunoassays for PEG

Background: Polyethylene glycols (PEGs) are hydrophilic polyethers widely used in pharmaceutical, cosmetic, food, and household products. PEG is usually safe and allergic reactions are rare, however according to literature, hypersensitivity is most likely underestimated and mild to life-threatening immediate-type hypersensitivity to PEG have been reported. PEG 2000 is an ingredient in some of the COVID-19 vaccines and is a possible cause of rare cases of adverse reactions to the vaccines that have been reported*. PEG hypersensitivity seems to depend on molecular weight (MW) and higher MW PEGs appear to be more allergenic. Based on this, we developed two ImmunoCAP PEG tests with different MW:s of PEG for measurement of anti-PEG specific IgE (sIgE) and specific IgG antibodies. Method(s): ImmunoCAP PEG 2000 and PEG 10000 Research Use Only (RUO) tests were developed according to conventional methods. As PEG is structurally related to polysorbates, a specific polysorbate 20 free washing solution was developed. The analytical characteristics of the ImmunoCAP PEG tests have been determined and an accelerated stability study has been performed. Result(s): The developed RUO ImmunoCAP PEG 2000 and PEG 10000 tests fulfilled internal standard RUO specifications using the polysorbate 20 free washing solution. Intra-and inter assay performance were evaluated at three concentrations from low to high on the sIgE measuring range (0-100 kUA/L). Overall results for intra-and inter assay performance were <=6.0 %CV and <=9.5 %CV, respectively. Anti-PEG IgG have been reported in human plasma samples with levels reaching up to 6.5 mug/mL (median 49.3 ng/mL). No anti-PEG IgG interference could be detected for these PEG tests when assayed with an anti-PEG IgG positive control in concentrations up to 6.5 mug/mL. An accelerated stability study indicated a shelf-life of two years for both PEG tests. Conclusion(s): Two ImmunoCAP PEG tests have been developed. These tests have been used as a complementary research tool to evaluate the risk for hypersensitivity reactions to PEG and to determine sIgE sensitization pattern in patient serum. In addition, studies have shown sIgE levels >0.1 kUA/L using these ImmunoCAP PEG tests for patients with a history of reactions to PEG together with positive skin prick testing. *It is important to understand that these reactions are extremely rare and should not discourage the general public from vaccination.

Modeling the supply chain network in the fast-moving consumer goods industry during COVID-19 pandemic

The outbreak of the COVID-19 pandemic in recent years has raised serious concerns about the distribution of fast-moving consumer goods products, given the freshness of their use. On the one hand, the distribution of fast-moving consumer goods with multiple vehicles has led to maintaining the freshness of items at the supply chain level, and on the other hand, it involves the high costs of using vehicles. Congestion of vehicles and drivers in the distribution of items has also increased the possibility of COVID-19 transmission. The importance of the above issue has led to the modeling of a multi-level supply chain problem in the FMCG industry by considering the freshness of items to reduce COVID-19 transmission. The most important issue considered in this article is to send fresh food in the shortest possible time to customers who cannot go to stores and wait in line to buy items in the conditions of Covid-19. Therefore, the designed model provides the possibility for customers to receive fresh food in addition to reducing costs and also reduce the possibility of contracting Covid-19. Designed supply chain network levels include suppliers of raw materials, manufacturers of consumer goods, distributors and end customers. In order to optimize the objectives of the problem, including minimizing the total costs of supply chain network design and maximizing the freshness of items, various strategic and tactical decisions such as locating potential facilities, routing vehicles, and optimally allocating the flow of goods should be made. Since the supply chain network model is considered to be NP-hard, meta-heuristic algorithms have been used to solve the problem by providing a modified priority-based encoding. The results show the high efficiency of the proposed solution method in a short time.

Edible alginate-based films with anti-SARS-CoV-2 activity.

The viability of SARS-CoV-2 on food surfaces and its propagation through the food chain has been discussed by several stakeholders, as it may represent a serious public health problem, bringing new challenges to the food system. This work shows for the first time that edible films can be used against SARS-CoV-2. Sodium alginate-based films containing gallic acid, geraniol, and green tea extract were evaluated in terms of their antiviral activity against SARS-CoV-2. The results showed that all these films have strong in vitro antiviral activity against this virus. However, a higher concentration of the active compound (1.25%) is needed for the film containing gallic acid to achieve similar results to those obtained for lower concentrations of geraniol and green tea extract (0.313%). Furthermore, critical concentrations of the active compounds in the films were used to evaluate their stability during storage. Results showed that gallic acid-loaded films lose their activity from the second week of storage, while films with geraniol and green tea extract only show a drop in activity after four weeks. These results highlight the possibility of using edible films and coatings as antiviral materials on food surfaces or food contact materials, which may help to reduce the spreading of viruses through the food chain.

The Storage and In-Use Stability of mRNA Vaccines and Therapeutics: Not A Cold Case.

The remarkable impact of mRNA vaccines on mitigating disease and improving public health has been amply demonstrated during the COVID-19 pandemic. Many new mRNA-based vaccine and therapeutic candidates are in development, yet the current reality of their stability limitations requires their frozen storage. Numerous challenges remain to improve formulated mRNA stability and enable refrigerator storage, and this review provides an update on developments to tackle this multi-faceted stability challenge. We describe the chemistry underlying mRNA degradation during storage and highlight how lipid nanoparticle (LNP) formulations are a double-edged sword: while LNPs protect mRNA against enzymatic degradation, interactions with and between LNP excipients introduce additional risks for mRNA degradation. We also discuss strategies to improve mRNA stability both as a drug substance (DS) and a drug product (DP) including the (1) design of the mRNA molecule (nucleotide selection, primary and secondary structures), (2) physical state of the mRNA-LNP complexes, (3) formulation composition and purity of the components, and (4) DS and DP manufacturing processes. Finally, we summarize analytical control strategies to monitor and assure the stability of mRNA-based candidates, and advocate for an integrated analytical and formulation development approach to further improve their storage, transport, and in-use stability profiles.

Quality assessment of routine produced mirasol pathogen reduction system treated platelet concentrates

Background: Prevention of transfusion-associated infections remains a challenge in transfusion medicine. The Mirasol Pathogen Reduction Technology (PRT) System uses riboflavin plus UV light to inactivate residual white blood cells and nucleic acid-containing pathogens to reduce the risk of transmission of bacteria, viruses, parasites, novel pathogens e.g SARS-CoV-2. This demonstrates the cumulative quality data of Mirasol-treated PC produced under routine conditions in our institute in the last year Methods: One hundred sixteen whole blood derived PCs, resulting from the pooling of 5 buffy coats with 250ml PAS-E solution were treated with the Mirasol technology. PCs were mixed with 35 ml Riboflavin solution and illuminated with UV-light in accordance to manufacturer's instructions. For quality control (QC) assessment the following parameters were investigated post-production (PP) and at the end of shelf-life (EOS) at days 5, 6 or 7: pH (ABL80 FLEX Blood Gas Analyzer, at 37degreeC), platelet yield (Cell- Dyn Ruby, Abbott) and CD62P-positive cells with and without TRAP-6 (100muM) using the FACS methodology with FITC-labelled CD62P antibody (Cytomics FC 500 Flow Cytometer, Beckman Coulter). Result(s): Mirasol-treated PCs showed a mean pH of 7.3 at PP and ranged 7.1 to 7.0 at EOS1. Platelet yield PP and EOS were consistent with 3.0 to 3.1 x1011 platelets (PLT)/unit. Platelet activation measured with CD62P+ expression w/o TRAP-6 was 27.7% at PP and ranged from 46.9 to 55.8 at EOS1;CD62P+ expression induced by TRAP-6 was 79.3 at PP and ranged from 72.3 to 68.1 at EOS1. Conclusion(s): The QC data on Mirasol-treated PCs produced during the past year showed encouraging results: all pH values remained far above 6.4, platelet yields remained stable suggesting min cell loss, with EOS yields always above the threshold of 2.5x1011 PLT/unit. Rates of CD62P+cells increased with time, an upregulation of CD62P+ with TRAP-6 was still detectable at EOS up to Day 7. The presented results confirm the data of the initial Mirasol validation at our site, showing the robustness of the technology. (Table Presented).

Environmental storage conditions influencing the filtration behavior of electret filters with repeated use

Worldwide attention has been paid to effective protection strategies against the COVID-19 pandemic. Filtering masks are generally kept for a certain period of shelf-life before being used, and frequently, they are used repeatedly with recurrent storages. This study investigates the effect of storage temperature and humidity on the structural characteristics and charges of an electret filter, associating with the filtration performance in terms of efficiency and pressure drop based on a practical use-storage scenario. For the repeated use conditions with recurrent storage, humid storage conditions significantly deteriorated the filtration efficiency as hygroscopic particles quickly wetted the surface and masked the surface charges. The high temperature rapidly deteriorated the filter charges and caused a lowered electrostatic filtration efficiency. In a heated condition, the web became fluffier, yet it did not directly affect the pressure drop or mechanical filtration efficiency. The approach of this study is progressive in that rigorous analysis was performed on examining the particle morphology and internal structure of filter media with varied storage conditions to link with the filtration performance and the effective lifetime. This study intends to provide a scientific reference guiding a desirable storage condition and replacement cycle of filtering masks considering the actual use habits and storage environment. © The Author(s) 2022.

Chemistry Manufacturing and Controls Development, Industry Reflections on Manufacture, and Supply of Pandemic Therapies and Vaccines.

This publication provides some industry reflections on experiences from the Chemistry, Manufacturing, and Controls (CMC) development and manufacture and supply of vaccines and therapies in response to the COVID-19 pandemic. It integrates these experiences with the outcomes from the collaborative work between industry and regulators in recent years on innovative science- and risk-based CMC strategies to the development of new, high-quality products for unmet medical needs. The challenges for rapid development are discussed and various approaches to facilitate accelerated development and global supply are collated for consideration. Relevant regulatory aspects are reviewed, including the role of Emergency Use/Conditional Marketing Authorizations, the dialogue between sponsors and agencies to facilitate early decision-making and alignment, and the value of improving reliance/collaborative assessment and increased collaboration between regulatory authorities to reduce differences in global regulatory requirements. Five areas are highlighted for particular consideration in the implementation of strategies for the quality-related aspects of accelerated development and supply: (1) the substantial need to advance reliance or collaborative assessment; (2) the need for early decision making and streamlined engagement between industry and regulatory authorities on CMC matters; (3) the need to further facilitate 'post-approval' changes; (4) fully exploiting prior and platform knowledge; and (5) review and potential revision of legal frameworks. The recommendations in this publication are intended to contribute to the discussion on approaches that can result in earlier and greater access to high-quality pandemic vaccines and therapies for patients worldwide but could also be useful in general for innovative medicines addressing unmet medical needs.

mRNA-Lipid Nanoparticle COVID-19 Vaccines: Structure and Stability

A drawback of the current mRNA-lipid nanoparticle (LNP) COVID-19 vaccines is that they have to be stored at (ultra)low temperatures (2). Understanding the root cause of the instability of these vaccines may help to rationally improve mRNALNP product stability and thereby ease the temperature conditions for storage. In this presentation we discuss proposed structures of mRNALNPs, factors that impact mRNA-LNP stability and strategies to optimize mRNA-LNP product stability. Analysis of mRNA-LNP structures reveals that mRNA, the ionizable cationic lipid and water are present in the LNP core. The neutral helper lipids are mainly positioned in the outer, encapsulating, wall. mRNA hydrolysis is an important driver for mRNA-LNP instability. It is currently a matter of debate whether water in the LNP core can freely interact with the mRNA and to what extent the degradation prone sites of mRNA are protected through a coat of ionizable cationic lipids. To improve the stability of mRNALNP vaccines, optimization of the mRNA nucleotide composition should be prioritized. Secondly, a better understanding of the milieu the mRNA is exposed to in the core of LNPs may help to rationalize adjustments to the LNP structure to preserve mRNA integrity. Moreover, drying techniques, such as lyophilization, are promising options still to be explored. As vaccines turn out to be the major weapon against the COVID-19 viral attack, the urge to develop more stable formulations is still growing and alternative, not-mRNA based products, may come to the forefront in situations where the (ultra) cold chain cannot be guaranteed. (Table Presented).

Sensory quality and shelf-life of locally produced British butters compared to large-scale, industrially produced butters

Purpose>The purpose of this pilot-scale study was to compare the quality of traditionally manufactured butters from local, small British producers with the quality of butters that are produced industrially.Design/methodology/approach>Butter samples were obtained after supervised site inspections of three traditional-butter manufacturers and one large-scale butter producer. The samples were subject to initial microbiological, chemical and sensory testing, followed by a refrigerated shelf-life study over 24 weeks.Findings>Traditional butters matched or exceeded the sensory quality of industrial butters, but spoilage microorganisms tended to grow faster on traditional butters. This seemed to be related to poorer water droplet dispersion in the manufacture of some of the traditionally made butters. Visible mould appeared on two of the traditional butters after eight weeks, but this occurred well after the nominal “best before” date.Originality/value>Prolonged lockdowns due to the current coronavirus disease (COVID-19) pandemic pose a threat to the food supply chain, and food produced by local manufacturers may become increasingly important. However, are foods produced by local small-scale manufacturers of a quality comparable to that produced using large-scale production facilities? To the best of the authors' knowledge, there is no comparative study of the quality and shelf-life of traditionally-produced and industrially-produced butters. The current work presents such a comparison together with an outline of how the process of traditional butter-making differs from commercial production in Britain.

A review on microgreens as an emerging food for health benefits

Microgreens became evident specialty food product that attains quality and higher attention these days. Young foliaged greens are relished as a delicacy for its color, crunchiness and flavor. Microgreens are a novel category of wholesome vegetables which can be harvested after the emergence of primary leaves. Microgreens have fresh aroma and used as freshly made ingredients. By and large, they are used as salads and garnishing for wide variety of dishes. These microgreens have high nutritional value as it contains ample amount of antioxidants, vitamins, minerals and nourishes the human health. Generally, cultivated microgreens are peas, kale, beets, radish, sunflower and arugula. However, they ordinarily enclose a quick fundamental measure because of speedy product deterioration. On examination, microgreens and mature greens, microgreens were the richest sources of water-soluble vitamin and zinc, which are suggested to spice up the immunity of the body throughout the current state of affairs of COVID-19 threat. Hence, these could also be observed as natural supplements. This paper aims to furnish an outline of the organic process facts, their comparison with sprouts, potential bioactive compounds, and cultivation, harvesting, and promoting of microgreens at the side of their future perspective.

Development of a competitive ELISA kit for evaluation of SARS-CoV-2 neutralizing antibody capacity in vaccinated individuals

The COVID-19 pandemic, caused by the SARS-CoV-2 virus, has been devastating human lives since 2019.While each country carries out their vaccination program, many of them also continue to work on vaccine development. Determination of SARS-CoV-2 neutralizing antibodies offers important information for evaluating immune responses to the virus. Neutralization capacity can contribute to the understanding of subjects such as the immune status of individuals, the need for revaccination, relapse and recovery from the disease, as well as evaluation of vaccine efficacy. Neutralizing antibodies block the virus by preventing the interaction of the virus's S protein receptor binding domain (RBD) with human angiotensin converting enzyme-2(ACE-2). The most commonly used methods for the detection of neutralizing antibody titer are cell culture experiments with the virus such as the plaque neutralization assay. While these tests require biosafety level 3 conditions, ELISA tests can be performed in general laboratory without any sterile environment. Furthermore, while traditional methods take 2-3 days, ELISA stands out with its ease of application and can give results in just 90 minutes. In this study, we developed a prototype ELISA kit which is based on the principle of blocking the protein-protein interaction between RBD-HRP and ACE-2 with a possible neutralizing antibody in serum. For this purpose, the RBD protein was first labeled with horseradish peroxidase (HRP). Optimum use concentrations of RBD-HRP protein and human serum in the selected dilution buffer and the amount of ACE-2 protein to be coated on the ELISA plate were determined. As a result of repeated studies with a large scale of serum, the coefficients of variation(CV) for intra/inter-assay were calculated as 10% and 12%, respectively. Preliminary results of accelerated shelf-life studies showed that the ELISA kit maintained its shelf life up to 1 year at +4°C.

Real-Time Monitoring the Effects of Storage Conditions on Volatile Compounds and Quality Indexes of Halal-Certified Kimchi during Distribution Using Electronic Nose.

The food logistics system is an essential sector for maintaining and monitoring the safety and quality of food products and becoming more crucial, especially during and after the pandemic of COVID-19. Kimchi is a popular traditional fermented food originally from Korea and easily changes because of the storage conditions. This study aims to evaluate the effects and the contributions of temperature to volatile compounds, quality indexes, and the shelf life of Halal-certified Kimchi, and to identify alcohol and find the correlation between the identified variables using an electronic nose and conventional method with the integration of multivariate analysis. Thirty-two volatile compounds (VOCs) were detected and correlated with pH, titratable acidity (TA), and lactic acid bacteria (LAB) counts during storage time. Ethanol was also found in the ripened Kimchi and possibly became the critical point of halal Kimchi products besides total acidity, pH, and LAB. Furthermore, the correlation between pH and benzaldehyde, titratable acidity and 3-methylbutanoic acid, and among lactic acid bacteria with ethanol, acetic acid, ethyl acetate, and 3-methylbutanoic acid properly can be used as a given set of variables in the prediction of food quality during storage and distribution.

An investigation of the use of dexrazoxane as a cardioprotectant in UK Teenage and Young Adult (TYA) Cancer Centres

Introduction: Around 1 in 10 childhood cancer survivors who receive an anthracycline develop a symptomatic cardiac event over time.1 Dexrazoxane, a free radical scavenger, has been shown to reduce surrogate markers of cardiac damage in children and young people receiving anthracycline chemotherapy.2 In February 2020, NHS England (NHSE) published a new clinical commissioning policy entitled: “Dexrazoxane for preventing cardiotoxicity in children and young people (under 25 years) receiving high-dose anthracyclines or related drugs for the treatment of cancer”.1 Given uncertainties regarding the robustness of the supporting data,1,2 a general unfamiliarity with the product and the timing of the publication of the policy (at the start of the COVID-19 pandemic) we hypothesised that these factors may all have impacted on the speed and degree of its adoption. Consequently we decided to undertake a survey of practice, with the aim of exploring awareness of the policy and use of the drug amongst UK TYA centres. Methods: A short questionnaire was designed using the www.onlinesurveys.ac.uk platform. The questionnaire was sent electronically to senior oncology/ haematology pharmacists from all 17 TYA Cancer Centres in the UK in March 2021 and was kept open for six weeks to allow centres sufficient time to respond. Responses were transferred to Microsoft Excel for data analysis. Results: Responses were received from all 17 UK TYA centres. All centres in England (n=13) were either very aware (69%) or somewhat aware (31%) of the dexrazoxane commissioning policy. The majority (three out of four) of the centres from the devolved nations were unaware of the policy. Five centres (29%) had used dexrazoxane as a cardioprotectant since February 2020 and a further five centres (29%) were considering its use. Reasons for not using the drug included: unconvinced by efficacy data (n=4), concerned re short and long-term side effects (n=3). Of those centres that had used the drug, three had only given it to 1-3 patients, one centre had given it to 7-9 patients and one centre had given it to >9 patients. None of the centres had a TYA Unit policy or guideline for the use dexrazoxane as a cardioprotectant, although two were in the process of writing one. Furthermore, although stipulated in the commissioning policy, only three out of five centres using the drug required MDT discussion prior to use. From a clinical perspective, there was a lack of consensus as to when in the treatment pathway to start the drug (i.e. with cycle one of chemotherapy or when a threshold dose had been reached). And from a practical perspective, concerns were raised about the short shelf-life of dexrazoxane and the workload implications for aseptic units. Conclusions: Despite generally good awareness of the dexrazoxane commissioning policy, use of the drug by TYA centres has been limited to date and clinical practice has not uniformly matched the recommendations contained within the policy. Further work is required to explore reasons for the slow and variable uptake and to also investigate potential differences in practice between TYA and paediatric centres.

IMPLEMENTATION OF STANDARD PARENTERAL NUTRITION (PN) IN A LARGE TERTIARY NEONATAL SERVICE DURING COVID-19 PANDEMIC - THE CONSIDERATIONS, THE CHALLENGES AND THE LESSONS LEARNT

The COVID-19 pandemic brought with it many challenges for the NHS;for our neonatal unit, staffing and resource concerns necessitated a review of PN provision to our dual site neonatal managed clinical service. Our service comprises of two sites (and includes neonatal surgical cots) and has a combined capacity of 90 cots. Prior to the pandemic the usual PN requirement was between 12 and 20 patients per day, approximately 75% of the PN was individualised (bespoke) and manufactured on site in our unlicensed aseptics units. To support the nursing teams in adult critical care areas, pharmacy aseptics unit were asked to manufacture ready to use infusions;the requirement to make new products along with staff shortages challenged our capacity. Patient individualised parenteral nutrition is highly complex, requiring specific prescriber training of those involved in requesting or ordering, and those involved in ensuring clinical suitability of the prescription. In addition, bespoke compounding or manufacturing is an intricate process requiring appropriately trained staff and specialised equipment. An MDT approach was adopted to review and improve the resilience of our PN service and reduce the need for aseptics manufacture. An options appraisal of the following factors was carried out: availability of sufficient product, license status of the products, nutritional content of regimens, lipid and protein sources, time taken to prescribe, time taken to clinically validate, time taken to prepare, storage requirements, stability/ shelf life of chosen product, time taken to set up, provision of vitamins and trace elements, total fluid volume required for nutrition, supplementation of electrolytes, composition of the PN (2 phase system vs 1 phase system), pump and equipment provision. For our neonatal population Baxter Numeta G13E and G16E bags were selected as the most appropriate option. Moving away from prescribing and administering individualised PN products to using Numeta we were challenged to: design an appropriate prescription chart and regimens, ensure that we were able to prescribe and administer supplementary electrolytes and fluids, review the use of filters for fungi, bacteria and endotoxins on lines used for the administration of PN, ensure that we had sufficient stock of IV lines to enable more frequent line changes, review PN - drug IV compatibility and provide training to prescribers, nurses and pharmacists. Standard bag PN allows greater flexibility to manage unstable patients and has increased our PN capacity. For the proportion of infants for whom Numeta is not appropriate we prescribe either 'start up potassium and sodium free PN' or individualised PN for infants who require long term PN with specific micro or macronutrient requirements. Audit is required to evaluate hypercalcaemia seen in a proportion of infants less than 2kg in weight. Numeta bags do not provide 100% of normal fluid volume for most patient's, the additional fluid requirement significantly increases the number of infusion pumps required to administer PN. After 15 months, Numeta continues to be used as the primary PN product in approximately 90% of our neonatal population.

Preventive measures for obesity pandemic during COVID-19 quarantine;choosing the right diet

Until recently, obesity was one of the greatest public health issues. At the moment, the world is counting deaths from COVID-19, and raging obesity pandemic is not in the focus. While the quarantine is the mainstay of COVID-19 prevention, it also opposes obesity prevention. Obesity is a risk factor for severe COVID-19 infection. Treatment of obesity during quarantine is challenging;trying to lose weight without the opportunity for outdoor activity or access to fresh and healthy foods may lead to frustration, depression and overeating. Therefore, we propose that patients should focus on preventing new weight gain instead of losing weight. It can be achieved by practicing indoor physical exercise together with adequate diet. The diet should be opposite from, "Western diet pattern'' and include foods easily obtainable during quarantine;with longer shelf life, but also rich in anti-inflammatory and immune-modulatory bioactive compounds. These characteristics of the diet make it simple to implement during quarantine, it helps in the process maintaing weight and supports immune system-all what is required to possibly reduce the risk of severe COVID-19 infection. The anti-inflammatory properties from given diet have beneficial role, especially in obese patients, as they have low grade chronic inflammation which additionally may worsen clinical course of COVID-19 infection.

CHEMICALLY DECORATED DECELLULARIZED CORNEA AS FULL-THICKNESS STROMAL SUBSTITUTE

During the ongoing Covid-19 pandemic, collection and donation of human cadaveric corneas are cumbersome. Decellularized corneas (DC) have gained intense popularity as a possible scaffold for corneal remodeling and as an alternative tissue source for corneal replacement. However, DC elicits immune response inspite of elimination of the cellular contents/antigens due to distortion of the collagen fibrils that exposes certain antigenic sites, which often lead to graft rejection. Therefore, here, we tested the hypothesis that cross-linking DC with chondroitin sulfate (CS) may help in restoring distorted conformational changes of the fibrous matrix and would reduce graft rejection. An in vitro immune response study confirmed that the cross-linked DC elicited the least immune response than DC. We implanted three sets of corneal scaffolds obtained from goat, i.e., native, decellularized, and DC conjugated with CS into rabbit stroma. Histology analysis, three months post-implantation confirmed seamless graft integration, cell migration, and no sign of inflammation in the crosslinked cornea. However, so far we have checked the immunogenic potential of decellularized and crosslinked cornea among cross-species(goat to rabbit). Now, before moving to a human clinical trial (patients with infectious keratitis), we are validating the decellularization of the human stromal layer using discarded human corneas not suitable for implantation, for the regeneration of the corneal endothelial layer. The decellularized, chemically decorated cornea will be tectonically strong, offer less immunogenicity, can be sterilized, and will have a longer shelf life. Through this novel study, we can meet the demand for alternative bioengineered human cornea for keratitis patients.