A study on biofilm production and antifungal drug resistance among Candida species from vulvovaginal and bloodstream infections

Sanyuktha Tulasidas,1 Pooja Rao,2 Sevitha Bhat,2 Radhakrishna Manipura1 1Department of Microbiology, Kasturba Medical College, Manipal Academy of Higher Education, Mangalore, Manipal, India; 2Department of Microbiology, Kasturba Medical College, Manipal Academy of Higher Education, Manipal McGill Center for Infectious Diseases, Mangalore, Manipal, India Introduction: Candida species, one among the opportunistic fungi, has become a common pathogen causing vaginal thrush and nosocomial bloodstream infections (BSIs). This study aims to evaluate the prevalence and antifungal susceptibility of various Candida species and slime production by Candida species in BSIs and vulvovaginal candidiasis (VVC). Materials and methods: A total of 176 samples were collected for a period of 1 year. Antifungal susceptibility testing and biofilm production testing were performed by the Kirby-Bauer method and crystal violet assay, respectively. Results: Out of 176 samples, 74 (42%) were from BSIs and 102 (58%) were from VVC. The biofilm production was comparatively high in blood isolates, 55 (74%), than cervical isolates, 45 (44%). Increase in the trends of non-albicans Candida (NAC) species was seen in our setup. Good susceptibility rates were seen among Candida species, 82.38% to voriconazole and an increasing resistance pattern of 26.13% to fluconazole. Conclusion: Speciation of Candida becomes important as the prevalence of NAC is increasing. Antifungal susceptibility testing by the disk diffusion method is cost effective and should be adopted in routine testing as there is an increasing azole resistance, especially in invasive NAC infections. In this study, there was no correlation of antifungal drugs with the biofilm production. Keywords: biofilm, Candida, azoles, vulvovaginal, bloodstream infection

Evaluating the Business Case for Continuous Manufacturing of Pharmaceuticals: A Supply Network perspective

This chapter addresses the challenges of evaluating the business case for continuous manufacturing of pharmaceuticals, looking beyond traditional technical assessments made at the unit operations or individual production facility level. It provides an overview of key concepts, approaches and tools for the early assessment of supply network configuration opportunities enabled by continuous production processing interventions. Multiple levels of analysis are considered with the aid of examples based on major UK research programmes on continuous production process technologies. Particular emphasis is placed on the potential for achieving enhanced product flexibility (in terms of volume and variety) and depending on scale, the optimum number and location of manufacturing operations to support speed to market and system-level cost benefits. In the case of multiple manufacturing operations using continuous production process technologies, where production facility replication through digital twins is becoming a key enabler, the chapter sets out a supply network design and analysis approach that evaluates the commercial and operational viability of alternative manufacturing supply network scenarios

Role of Knowledge Management in Development and Lifecycle Management of Biopharmaceuticals

The final publication is available at Springer via https://doi.org/10.1007/s11095-016-2043-9.Knowledge Management (KM) is a key enabler for achieving quality in a lifecycle approach for production of biopharmaceuticals. Due to the important role that it plays towards successful implementation of Quality by Design (QbD), an analysis of KM solutions is needed. This work provides a comprehensive review of the interface between KM and QbD-driven biopharmaceutical production systems as perceived by academic as well as industrial viewpoints. A comprehensive set of 356 publications addressing the applications of KM tools to QbD-related tasks were screened and a query to gather industrial inputs from 17 major biopharmaceutical organizations was performed. Three KM tool classes were identified as having high relevance for biopharmaceutical production systems and have been further explored: knowledge indicators, ontologies, and process modeling. A proposed categorization of 16 distinct KM tool classes allowed for the identification of holistic technologies supporting QbD. In addition, the classification allowed for addressing the disparity between industrial and academic expectations regarding the application of KM methodologies. This is a first of a kind attempt and thus we think that this paper would be of considerable interest to those in academia and industry that are engaged in accelerating development and commercialization of biopharmaceuticals.Industrial Methods for Process Analytical Chemistry - From Measurement Technologies to Information Systems (imPACts