Harvest

The “Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century—A Risk Based Approach” initiative announced by the FDA in August 2002 to improve and modernize pharmaceutical manufacturing facilitated adoption of process analytical technology (PAT) by the pharmaceutical industry. The potential for improved operational control and compliance resulting from continuous real-time quality assurance was highlighted as a likely benefit that would result from PAT implementation. A considerable amount of work has been done on this topic by academic and industrial contributors in the last decade. In this paper, we will start with a brief overview of evolution of PAT concepts and a review of their application in the wider pharmaceutical industry. The rest of the paper focuses on PAT applications for biotech processes with emphasis on developments in the last five years. It is our observation that while significant advances have been accomplished with regard to our ability to analyze/monitor key process and quality attributes in the biotech industry, much more needs to be done with regard to utilizing the collected data for subsequent control of the process, to achieve optimum yield and product quality. The latter is necessary to achieve the benefits that will result from PAT implementation. Figure Ease of PAT implementation for some of the commonly used unit operations in biotech processes

Migration occurs when key aspects of the life cycle such as growth, reproduction, or maintenance cannot all be completed in one location. The Arctic habitats are variable and Arctic species are often migratory. The predictable nature of migrations in both space and time allow Arctic people to harvest fishes and marine mammals. We describe migratory/dispersal behavior in four types of taxa from the Canadian Arctic: anadromous and freshwater fishes, marine fishes, marine invertebrates, and marine mammals. Patterns of migration are remarkably different between these groups, in particular between distances migrated, seasonal timing of migrations, and the degree of reproductive isolation. Migratory anadromous and freshwater fishes become adapted to specific locations resulting in complex life histories and intra- and inter-population variation. Marine mammals not only migrate longer distances but also appear to have distinct demographic populations over large scales. Marine fishes tend to be panmictic, probably due to the absence of barriers that would restrict gene flow. Migratory patterns also reflect feeding or rearing areas and/or winter refugia. Migratory patterns of harvested aquatic organisms in the Canadian north are extremely variable and have shaped the north in terms of harvest, communities, and culture.

Abstract: Trophic cascades triggered by fishing have profound implications for marine ecosystems and the socioeconomic systems that depend on them. With the number of reported cases quickly growing, key features and commonalities have emerged. Fishery-induced trophic cascades often display differential response times and nonlinear trajectories among trophic levels and can be accompanied by shifts in alternative states. Furthermore, their magnitude appears to be context dependent, varying as a function of species diversity, regional oceanography, local physical disturbance, habitat complexity, and the nature of the fishery itself. To conserve and manage exploited marine ecosystems, there is a pressing need for an improved understanding of the conditions that promote or inhibit the cascading consequences of fishing. Future research should investigate how the trophic effects of fishing interact with other human disturbances, identify strongly interacting species and ecosystem features that confer resilience to exploitation, determine ranges of predator depletion that elicit trophic cascades, pinpoint antecedents that signal ecosystem state shifts, and quantify variation in trophic rates across oceanographic conditions. This information will advance predictive models designed to forecast the trophic effects of fishing and will allow managers to better anticipate and avoid fishery-induced trophic cascades.Resumen: Las cascadas tróficas disparadas por la pesca tienen implicaciones profundas para los ecosistemas marinos y los sistemas socioeconómicos que dependen de ellos. Con el número de casos reportados incrementando rápidamente, han emergido atributos clave y similitudes. Las cascadas tróficas inducidas por pesquerías a menudo presentan tiempos de respuesta diferenciales y trayectorias no lineales entre los niveles tróficos y pueden ser acompañados por cambios en el estado de los ecosistemas. Más aun, su magnitud parece ser dependiente del contexto, variando como una función de la diversidad de especies, la oceanografía regional, la perturbación física local, la complejidad del hábitat y la naturaleza de la pesquería misma. Para conservar y manejar ecosistemas marinos explotados, existe una necesidad imperiosa por mejorar el entendimiento de las condiciones que promueven o inhiben las consecuencias en cascada de la pesca. Más aun, la investigación futura debe examinar la interacción de los efectos tróficos de la pesca con otras perturbaciones humanas, identificar especies estrechamente interactuantes y los atributos del ecosistema que confieren resiliencia a la explotación, determinar los rangos de disminución de depredadores que provoca las cascadas tróficas, identificar antecedentes que indiquen cambios de estado de los ecosistemas y cuantificar la variación en las tasas tróficas en condiciones oceanográficas diferentes. Esta información mejorará los modelos predictivos diseñados para estimar los efectos tróficos de la pesca y permitirá que los manejadores anticipen y eviten las cascadas tróficas inducidas por pesquerías.Resumen: Las cascadas tróficas disparadas por la pesca tienen implicaciones profundas para los ecosistemas marinos y los sistemas socioeconómicos que dependen de ellos. Con el número de casos reportados incrementando rápidamente, han emergido atributos clave y similitudes. Las cascadas tróficas inducidas por pesquerías a menudo presentan tiempos de respuesta diferenciales y trayectorias no lineales entre los niveles tróficos y pueden ser acompañados por cambios en el estado de los ecosistemas. Más aun, su magnitud parece ser dependiente del contexto, variando como una función de la diversidad de especies, la oceanografía regional, la perturbación física local, la complejidad del hábitat y la naturaleza de la pesquería misma. Para conservar y manejar ecosistemas marinos explotados, existe una necesidad imperiosa por mejorar el entendimiento de las condiciones que promueven o inhiben las consecuencias en cascada de la pesca. Más aun, la investigación futura debe examinar la interacción de los efectos tróficos de la pesca con otras perturbaciones humanas, identificar especies estrechamente interactuantes y los atributos del ecosistema que confieren resiliencia a la explotación, determinar los rangos de disminución de depredadores que provoca las cascadas tróficas, identificar antecedentes que indiquen cambios de estado de los ecosistemas y cuantificar la variación en las tasas tróficas en condiciones oceanográficas diferentes. Esta información mejorará los modelos predictivos diseñados para estimar los efectos tróficos de la pesca y permitirá que los manejadores anticipen y eviten las cascadas tróficas inducidas por pesquerías.

As large, long-lived seabirds with delayed and slow reproduction, albatrosses have low intrinsic mortality rates and are especially vulnerable to extinction from extrinsic sources of mortality such as fishery bycatch. Leg-band recovery information for waved albatrosses revealed mortality from both incidental catch and intentional catch for human consumption. Annual adult survival in 1999–2005, estimated from capture-mark-recapture data, was lower than historical estimates. This recent increase in adult mortality probably contributed to recent and dramatic shrinkage of the breeding population; periodic matrix models confirm that population growth rate is most sensitive to changes in adult survival. Banding data and recovery information also suggest that capture by fisheries is male-biased, which should reduce fecundity in this species with obligate bi-parental care. This new documentation of bycatch, harvesting, and associated demographic consequences provides reason for serious concern about the persistence of the single breeding population of the waved albatross.

Disease in wildlife populations is often controlled through culling. But when healthy individuals are removed and diseased individuals are left in the population, it is anticipated that prevalence of disease increases. Although this scenario is presumably common in exploited populations where infected individuals are less marketable, it is not widely reported in the literature. We describe this scenario in a marine turtle fishery in the Turks and Caicos Islands (TCI), where green turtles are harvested for local consumption. During a 2-year period, we recorded the occurrence of fibropapillomatosis (FP) disease in green turtles (Chelonia mydas) captured during in-water surveys and compared it with that of turtles landed in the fishery. 13.4% (n = 32) of turtles captured during in-water surveys showed externally visible signs of FP. FP occurred at specific geographic locations where fishing also occurred. Despite the disease being prevalent in the size classes selected by fishers, FP was not present in any animals landed by the fishery (n = 162). The majority (61%) of fishers interviewed expressed that they had caught turtles with FP. Yet, 82% of those that had caught turtles with the disease chose to return their catch to the sea, thereby selectively harvesting healthy turtles and leaving those with the disease in the population. Our study illustrates that fisher choice may increase the prevalence of FP disease and highlights the importance of this widely neglected driver in the disease dynamics of exploited wildlife populations.