Democratic Republic of the Congo planning meeting, 5-6 Dec 2007. Workshop report

The WorldFish Center and FAO are implementing a regional programme entitled "Fisheries and HIV/AIDS in Africa; investing in sustainable solutions", funded by the Swedish International Development Cooperation Agency (Sida) and the Norwegian Ministry of Foreign Affairs. In DR Congo, the main project site is Kasenga area situated in Katanga Province. The Department of Fisheries and National AIDS Council are the main stakeholders who will utilize the results of the research to influence policy. Research institutions and NGOs will implement the research and pilot interventions in the Katanga Province as agreed during the workshop. The Workshop objectives are 1) To agree on the research focus for the DR Congo component within the overall project framework 2) To develop a detailed annual work plan for 2008, and an overall work plan to the end of the project in March 2010 3) As part of these work plans, to agree on milestones, deliverables and identify indicators 4) To identify linkages with related projects and agree how these linkages will be managed.Fisheries, AIDS, Public health, HIV, Nutritive value

Malawi / Mozambique implementation partners planning meeting, 15-16 Oct 2007. Workshop report

The WorldFish Center and FAO are implementing a regional programme entitled "Fisheries and HIV/AIDS in Africa; investing in sustainable solutions", funded by the Swedish International Development Cooperation Agency (Sida) and the Norwegian Ministry of Foreign Affairs. The WorldFish Center organized a stakeholder workshop for planning of the activities. under the project Fisheries and HIV/AIDS in Africa for Malawi and Mozambique focusing on the Nacala corridor. The meeting was expected to generate ideas on the strategy of the program toward its implementation in both countries and come up with the list of potential partners from both countries as well as defining their roles and responsibilities in the project. The objectives of the workshop are to: 1) Create a shared understanding of programme objectives and processes 2) Develop an understanding of the technical programme focus and approaches (value chain, gender, pilot project, action research) 3) Agree on national programme outputs and targets, building on contributions by components, partners 4) Develop work plans and budget for the national componentFisheries, AIDS, Public health, HIV, Nutritive value

Failure of the Mycobacterium bovis BCG vaccine: Some species of environmental mycobacteria block multiplication of BCG and induction of protective immunity to tuberculosis

The efficacy of Mycobacterium bovis bacillus Calmette-Guerin (BCG) vaccine against pulmonary tuberculosis (TB) varies enormously in different populations. The prevailing hypothesis attributes this variation to interactions between the vaccine and mycobacteria common in the environment, but the precise mechanism has so far not been clarified. Our study demonstrates that prior exposure to live environmental mycobacteria can result in a broad immune response that is recalled rapidly after BCG vaccination and controls the multiplication of the vaccine. In these sensitized mice, BCG elicits only a transient immune response with a low frequency of mycobacterium-specific cells and no protective immunity against TB. In contrast, the efficacy of TB subunit vaccines was unaffected by prior exposure to environmental mycobacteria. Six different isolates from soil and sputum samples from Karonga district in Northern Malawi (a region in which BCG vaccination has no effect against pulmonary TB) were investigated in the mouse model, and two strains of the Mycobacterium avium complex were found to block BCG activity completely

Iodine source apportionment in the Malawian diet

The aim of this study was to characterise nutritional-I status in Malawi. Dietary-I intakes were assessed using new datasets of crop, fish, salt and water-I concentrations, while I status was assessed for 60 women living on each of calcareous and non-calcareous soils as defined by urinary iodine concentration (UIC). Iodine concentration in staple foods was low, with median concentrations of 0.01 mg kg−1 in maize grain, 0.008 mg kg−1 in roots and tubers, but 0.155 mg kg−1 in leafy vegetables. Freshwater fish is a good source of dietary-I with a median concentration of 0.51 mg kg−1. Mean Malawian dietary-Iodine intake from food, excluding salt, was just 7.8 μg d−1 compared to an adult requirement of 150 μg d−1. Despite low dietary-I intake from food, median UICs were 203 μg L−1 with only 12% defined as I deficient whilst 21% exhibited excessive I intake. Iodised salt is likely to be the main source of dietary I intake in Malawi; thus, I nutrition mainly depends on the usage and concentration of I in iodised salt. Drinking water could be a significant source of I in some areas, providing up to 108 μg d−1 based on consumption of 2 L d−1

Nutritional status and functional ability of older people in rural Malawi.

A cross-sectional study was undertaken in Lilongwe, Malawi to ascertain the levels of malnutrition and functional impairment among older people, examine the relationship between nutritional status and function ability and identify risk factors for poor nutritional status. Selected anthropometric measurements were taken and nutritional indices were derived using standard equations. Functional ability was assessed by questionnaire (activities of daily living [ADLs]) and tests which assess manual dexterity, handgrip strength and psychomotor function. Respondents were interviewed using a pre-tested questionnaire and a basic clinical examination was conducted. A total of 296 respondents (97 males, 199 females) aged from 55 to 94 years were studied. Men were significantly heavier and taller than women but had smaller mid-upper arm circumferences and triceps skinfolds than women. Prevalence of undernutrition defined as body mass index (BMI) <18.5 kg/m2, was 33.7% among males and 27.7% among females. Over 90% of all respondents were independent in ADLs and men were generally stronger and faster than women in performing functional tests except for psychomotor function. Functional ability declined significantly with age in both sexes except for manual dexterity among women. Handgrip strength emerged as the most important predictor of BMI, contributing to 15.8% and 11.6% of the variation in BMI of males and females, respectively. Low BMI was associated with poor handgrip strength, a history of smoking, fear of dependence and disability, poverty and living alone among males and among females, it was associated with poor handgrip strength, reduced food intake during the pre-harvest season and a history of anaemia. The study has demonstrated for the first time that undernutrition is a significant problem among older people in Malawi. It also confirms that poor nutritional status is associated with poor functional ability (as assessed by handgrip strength), and that it is possible to identify risk factors of nutritional vulnerability in this population. The study highlights the need to incorporate older people into existing and future nutrition and health programmes

Evaluating Institutional Arrangements to Support Watershed-scale Cumulative Effects Assessment in the Grand River Watershed, Canada

The Grand River watershed (GRW) lies within a designated urban growth plan area known as the Greater Golden Horseshoe (GGH) region in Southern Ontario, Canada. Development activities within this watershed cause environmental effects that accumulate over space and time resulting in degradation of water resources. Some of these cumulative environmental effects include poor water quality and quantity, increased sedimentation and surface run-off. In light of such cumulative effects issues, this research study attempts to advance watershed-scale cumulative effects assessment (W-CEA) by evaluating institutional arrangements (IAs) to support it in the GRW. The methods applied in evaluating these IAs include document review, a focus group and semi-structured interviews. The document review both positioned the research study within the current literature of watershed management and cumulative effects assessment and revealed important resource management information related to W-CEA in the GRW, while the focus group yielded an evaluative framework for existing institutional arrangements. A semi-structured interview schedule was then developed to investigate in-depth the status of institutional arrangements within the GRW. Twenty-nine interviews were conducted with academic experts; project proponents; government and watershed agencies; non-governmental organizations; First Nations; and others. Interviewees discussed eight themes related to institutional arrangements identified as prerequisites for supporting W-CEA: lead agency; multi-stakeholder collaboration; CEA baselines, indicators and thresholds; multi-scaled monitoring; data management and coordination; vertical and horizontal policy and planning linkages; enabling legislation and financial resources. Data analysis reveals varying opinions on the capacity of existing institutional arrangements to support W-CEA at present due to different understanding of the tasks and duties required for W-CEA, and a plethora of management mandates within the watershed. The interview data also show that scattered monitoring data and lack of a strong responsible authority for W-CEA in the GRW also hamper institutional capacity. Study participants raised questions about whether existing science in the watershed is ‘mature’ enough to conduct W-CEA at this time, and there is a documented need to identify a potential funding authority for watershed-scale initiatives. Lessons learnt help to advance W-CEA frameworks in Canada and abroad

An Examination of the Case for A Bank of Japan Digital Yen

departmental bulletin pape

A dual platform revolutionizing gene therapy manufacturing

Advanced therapies enable for many indications with no current treatment a significant improvement in quality of life and in some cases a chance at life altogether. The commercialization of those breakthrough therapies rely on manufacturing technologies primary developed for the mAbs industry. Indeed, the commercialization of mAb products was accompanied by technology advances reaching high-capacity and cost-effective processes within integrated and continuous solutions. Nevertheless, in contrast with mAbs where the annual demand (in the US) can be estimated between hundreds of grams to hundreds of kilograms, GT products show an annual demand variability of over 7 logs. Currently used technologies present some limitations in reaching the capacity required by high-demand GT indications resulting in process scale-out and related overall performance decrease. As GT developers often endeavor to target numerous indications, the significant variability in annual demand has pushed them to adopt technologies depending on the types of applications, rather than adopting a single flexible technology. As lessons learn from the mAbs industry the development of a flexible technology accommodating most process requirements adapted to GT products could facilitate viral vector manufacturing while accelerating the availability of advanced therapies at reduced costs. Please click Additional Files below to see the full abstract

The NevoLineTM manufacturing system: Intensification & integration of upstream and downstream processing in a low-footprint, automated platform for viral production

These guidelines have been prepared in the format that should be used for the abstract submission. Authors should replace the text of this template in order to prepare their abstracts. Fonts, sizes and spacing should be used as they are used in this document. Page size is US 8.5 inch x 11 inch, top and bottom margin 0.8 inches, left and right margin 0.8 inches. Body text should be written in Arial, 10 pt, single spacing. The Abstract, in English, should introduce the proposed paper’s subject, summarize its contents, explain any unique aspects, and clearly indicate the specific relevance to the themes of the Conference. Do not sub-divide the text into separate sections. References may be included at the bottom. The world is facing an under-supply of some key vaccines due to poor synergies between growing market demands and aging production models. In this light, we have developed a proof of concept of a vaccine manufacturing platform aiming at increasing availability and affordability of vaccines - the NevoLineTM system. This simulated continuous and automated platform integrates both USP[1] and DSP[2] processes and is encapsulated into an isolator, making it a self-contained production unit (6m²). The technology relies on a single-use, high-density fixed-bed bioreactor operated in perfusion chained with downstream filtration, clarification and polishing steps to (a) decrease batch time, (b) reduce equipment utilization, (c) optimize utilities consumption and (d) intensify operations. By optimizing single-use technologies we are able to drastically reduce CAPEX[3], CoGs[4] and footprint and increase production capacity. Such manufacturing platform can easily be implemented into flexible facilities with simplified infrastructure, increasing adaptability in production and capacity for record time-to-market. This study will present the platform proof of concept on Vero line and trivalent inactivated polio vaccine (sIPV) production, achieving low CoGs (0,28$/dose for a trivalent sIPV) and large capacity. The presentation will feature the description of engineering development, but also results of cell growth, infections and product quality, as well as a description of the CAPEX, CoGS and capacity calculations. This manufacturing platform is undergoing sIPV process scale-up and pre-clinical bulk production. The NevoLine system is expected to produce any type of viral vaccine at a very low cost and large capacities to face global health challenges. [1] Upstream [2] Downstream [3] Capital expenditure [4] Cost of good

Integrated upstream and midstream processing with scalable pre-configurated single- use assemblies for accelerated commercial reach

The growth of single-use technologies (SUT) has revolutionized the bioprocess industry. The implementation of such technologies was motivated by a substantial reduction in processing time and operational costs compared to their stainless-steel counterparts. Integrated within automated platforms such as the NevoLine™ Upstream, SUT reveal their full potential by offering an increased flexibility and supporting continuous processing. With 100s of different SU configurations the NevoLine platform can accommodate most upstream and midstream processes by integrating four unit-operations in a single manufacturing solution. Cell culture and viral production steps lie in scalable SU bioreactors (SUBs) available in various sizes optimal for process development, as well as clinical and commercial GMP production of viral vaccines, viral vectors for gene therapy and other emerging applications. The SUBs are featured in a range of scale-down automated manufacturing systems that ease scalability. The improved sterility assurance and controls offered by SUT enable predictable batch-to-batch performances and release. The pre-gamma eradiated SU assemblies integrated in Univercells Technologies’ manufacturing systems open the door to ready-to-use solutions reducing installation time and easing sterile continuous processing. This study will demonstrate how the NevoLine Upstream integrated platform relying on SU assemblies can support continuous processing and accelerate commercial reach. It will focus on the following points: Intensified cell growth and viral production in the SU scale-X™ bioreactor with up to 100-times increase in titer compared to traditional technologies with experimental results in various gene therapy and vaccine applications. Bioreactor characterization with scalability demonstration from scale-X hydro 2.4 m² to nitro 200 m² cell growth surface by maintaining fluid flow homogeneity, gradient, and volume to surface ratio across scales. Homogeneity within the fixed-bed will be demonstrated by sampling experiments with confident results. The scalability will be demonstrated by similar cell growth and viral titers per m² of growth surface profiles across scales. Increased process flexibility at commercial scale with the integrated and automated NevoLine Upstream platform adapted to multi-product facilities and variability in production capacity demand. A significant reduction in operational footprint (up to 3-times) enabled by intensified and integrated SU assemblies