A Master Cell Bank (MCB) banking troubleshooting case study: Challenges and process improvements with comprehensive root cause analysis

Mammalian cells, especially Chinese hamster ovary (CHO) cells, are routinely used in the biopharmaceutical industry for production of recombinant therapeutic proteins. Master Cell banking is one of the key step during drug development, which ensures preservation of cells at low temperatures for an extended period of time for GMP drug substance manufacturing. CHO cells can show significant variation in growth characteristics during cell line development. This variation necessitates the need for a robust Master Cell Bank (MCB) manufacturing process to ensure consistent MCB thaw and growth. Numerous efforts have been done to understand the cryopreservation mechanism as well as techniques to improve the robustness of banking processes. However, failure of MCB releasing still happens across the industry. A case study will be presented highlighting experiments carried out to identify root cause of MCB thaw and expansion variability. In this study, the health of the cells was examined using an Apoptosis assay and Transmission Electron Microscopy (TEM) analysis to gain a better understanding of the cell bank health. Process improvements that included further passaging of the cell line for improved robustness of the MCB manufacturing process will be discussed

Remembering the Sea: Personal and Communal Recollections of Maritime Life in Jizan and the Farasan Islands, Saudi Arabia

This is the final version of the article. Available from the publisher via the DOI in this record.People create narratives of their maritime past through the remembering and forgetting of seafaring experiences, and through the retention and disposal of maritime artefacts that function mnemonically to evoke or suppress those experiences. The sustenance and reproduction of the resulting narratives depends further on effective media of intergenerational transmission; otherwise, they are lost. Rapid socio-economic transformation across Saudi Arabia in the age of oil has disrupted longstanding seafaring economies in the Red Sea archipelago of the Farasan Islands, and the nearby mainland port of Jizan. Vestiges of wooden boatbuilding activity are few; long-distance dhow trade with South Asia, the Arabian-Persian Gulf and East Africa has ceased; and a once substantial pearling and nacre (mother of pearl) collection industry has dwindled to a tiny group of hobbyists: no youth dive today. This widespread withdrawal from seafaring activity among many people in these formerly maritime-oriented communities has diminished the salience of such activity in cultural memory, and has set in motion narrative creation processes, through which memories are filtered and selected, and objects preserved, discarded, or lost. This paper is a product of the encounter of the authors with keepers of maritime memories and objects in the Farasan Islands and Jizan. An older generation of men recall memories of their experiences as boat builders, captains, seafarers, pearl divers and fishermen. Their recounted memories are inscribed, and Arabic seafaring terms recorded. The extent of the retention of maritime material cultural items as memorials is also assessed, and the rôle of individual, communal and state actors in that retention is considered. Through this reflection, it becomes clear that the extra-biological memory and archive of the region’s maritime past is sparse; that intergenerational transmission is failing; that the participation of state agencies in maritime heritage creation is highly limited; and that, as a result, memories current among the older generation have limited prospect of survival. These memories, recorded and interpreted here, identify the Farasan Islands as a former centre of the pearling industry in the Red Sea, and identify them and Jizan as open to far-reaching maritime-mediated cultural influences in an era before the imposition of the attributes of the modern nation-state.This study was funded by the Golden Web Foundation (UK registered charity number 1100608), with additional support from the Seven Pillars of Wisdom Trust (UK registered charity number 208669)

Research strategies for organizational history:a dialogue between historical theory and organization theory

If history matters for organization theory, then we need greater reflexivity regarding the epistemological problem of representing the past; otherwise, history might be seen as merely a repository of ready-made data. To facilitate this reflexivity, we set out three epistemological dualisms derived from historical theory to explain the relationship between history and organization theory: (1) in the dualism of explanation, historians are preoccupied with narrative construction, whereas organization theorists subordinate narrative to analysis; (2) in the dualism of evidence, historians use verifiable documentary sources, whereas organization theorists prefer constructed data; and (3) in the dualism of temporality, historians construct their own periodization, whereas organization theorists treat time as constant for chronology. These three dualisms underpin our explication of four alternative research strategies for organizational history: corporate history, consisting of a holistic, objectivist narrative of a corporate entity; analytically structured history, narrating theoretically conceptualized structures and events; serial history, using replicable techniques to analyze repeatable facts; and ethnographic history, reading documentary sources "against the grain." Ultimately, we argue that our epistemological dualisms will enable organization theorists to justify their theoretical stance in relation to a range of strategies in organizational history, including narratives constructed from documentary sources found in organizational archives. Copyright of the Academy of Management, all rights reserved

Subchondral Bone Degradation Following Bone Marrow Stimulation -An MRI Analysis-

Category: Ankle Introduction/Purpose: Microfracture is the most common operative procedure for the treatment of osteochondral lesions of the talus (OLT). The role of the subchondral bone (SCB)/plate (SCBP) is recognized as one of the most significant factors providing joint-loading support to the ankle. Greater attention has recently been paid to the SCBP and its effects on overlying hyaline and fibrocartilage function. However, damage to the SCB and SCBP during microfracture may irreversibly change the joint loading support of the ankle, leading to reparative cartilage degradation. The purpose of this study is to investigate the morphological change in the SCB and SCBP after microfracture for OLT by developing a novel magnetic resonance imaging (MRI) scoring system specifically for evaluating SCB and SCBP. Methods: Twenty patients who underwent microfracture for OLT and had at least a one year follow-up 3-Tesla MRI between 2008 and 2011 were selected. A SCB Health scoring system was developed to assess the condition of the SCB using 3-Tesla MRI. The SCB Health score is based on the amount of edema, subchondral cyst diameter, qualitative change in SCBP morphology and thickness change of the SCBP (Table 1). Nine of the twenty patients had two follow-up MRIs, and differences in their scores were calculated. The clinical evaluation was assessed using the Foot and Ankle Outcome Scores (FAOS) preoperatively and at final follow-up. Results: At first follow-up MRI, 65% of patients had mild or greater edema, 40% had subchondral cysts, 65% had irregularity or collapse of their SCBP and 85% had a >25% change in SCBP thickness. The overall SCB Health score of 90% of patients were abnormal. Of the nine patients who had a subsequent follow-up MRIs, the mean time between the first and second study was 22±6 months. The scores between the two time points were not statistically significant (p=0.347, p=0.559, p=0.169, p=0.347 p=0.154 for edema, subchondral cyst diameter, qualitative SCBP measurements, SCBP thickness change and overall SCB Health score, respectively). The mean FAOS score improved significantly from 55.5±16.8 preoperatively to 76.0±12.3 at final follow-up (p<0.05). Conclusion: The SCB and SCBP were not completely healed in 90% of patients at a mean 18 months follow-up following microfracture of the talus. Subsequently, morphological changes were not restored at a mean 43 months at second follow-up in a smaller subset of patients. Most previous studies have focused on the degeneration of the articular cartilage layer, and its effect on clinical outcomes. The authors of current study believe that looking at the changes in the SCB may provide additional information as to why BMS procedures fail in the long-term

Nextstrain: real-time tracking of pathogen evolution

Understanding the spread and evolution of pathogens is important for effective public health measures and surveillance. Nextstrain consists of a database of viral genomes, a bioinformatics pipeline for phylodynamics analysis, and an interactive visualisation platform. Together these present a real-time view into the evolution and spread of a range of viral pathogens of high public health importance. The visualization integrates sequence data with other data types such as geographic information, serology, or host species. Nextstrain compiles our current understanding into a single accessible location, open to health professionals, epidemiologists, virologists and the public alike.; All code (predominantly JavaScript and Python) is freely available from github.com/nextstrain and the web-application is available at nextstrain.org.; [email protected], [email protected], [email protected]

southeastern Alaska in 1998

Abundance, range and movements of a feeding aggregation o

Achilles Tendon Repair- A Systematic Review of Overlapping Meta-Analyses

Category: Sports Introduction/Purpose: Acute Achilles tendon ruptures (ATR) are a common sports-related injury with an incidence of between 8-37 per 100,000 per year. While there are several meta-analyses published on the optimal treatment of ATR based on randomized control trials, the reported outcomes conflict between each meta-analysis due to different methodologies. The aim of this study is to systematically review the clinical results represented in meta-analyses in the current literature on acute ATR. Methods: Two independent reviewers performed the literature search based on the PRISMA guidelines to identify meta-analyses on Achilles tendon repair. Clinical results, including the re-rupture rates, wound infection rates and overall complication rates were analyzed. Level of evidence (LOE) and methodological quality of evidence (MQOE), using the AMSTAR score, were evaluated. A statistically significant difference (SSD) was defined as p < 0.05. Each meta-analysis was categorized into one of the following subgroupings: 1) Operative vs Non-Operative Treatment (with Conservative Rehabilitation) [OC vs NOC], 2) Operative vs Non-Operative Treatment (with Functional Rehabilitation) [OF vs NOF], 3) Conservative Rehabilitation vs Functional Rehabilitation (with Operative Treatment) [OC vs OF], and 4) Open vs. Percutaneous Repair (with Conservative Rehabilitation) [OC vs POC]. Results: Four studies compared OC and NOC. Re-rupture rates ranged from 3.1-6.4% in OC and 10.0-13.0% in NOC. Two of these studies showed statistical significance in favour of OC. There was no SSD was seen in other complications. Three studies compared OF and NOF. Re-rupture rates ranged from 3.8-5.0% in OF and 6.0-11.9% in NOF, no study showed a SSD. There was no SSD in other complications. Three studies compared OF and OC. Re-rupture rates ranged from 2.13-3% in OF and 1.1-2.1% in OC, no study showed a SSD. Four studies compared OC and PSC. Re-rupture rates ranged from 2.2-4.4% in OC and 1.1-2.1% in PSC, no study showed a SSD. In all included studies there was SSD in wound infection rates, in favour of PSC. Conclusion: Overall there exists a large volume of high quality meta-analyses on Achilles tendon repair. The re-rupture rates were lower in operative treatment in all studies, even when early functional rehabilitation was used. However, while early functional rehabilitation may allow early mobility but the rehabilitation method can be demanding. Although there was no difference between percutaneous and open repair on the re-rupture rate, there was an overall reduction in wound infection after percutaneous repair. The results within this study can help determine the optimal treatment for patients