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Double entry method for the verification of data a chromatography data system receives
The importance of software validation increases since the need for high usability and suitability of software applications grows. In order to reduce costs and manage risk factors, more and more recommendations and rules have been established. In the field of pharmacy the vendors of so-called chromatography data systems (CDSs) had to implement the guidelines of the Code of Federal Regulations Title 21 (CFR 21) during the last few years in order to fulfill the increasing requirements. The CFR 21 part 11 deals with electronic records and signatures. This part is binding for each company in the regulated environment that wishes to create, edit and sign electronic information instead of printing them on paper. Subsection CFR 21 part 11.10(h) explains how to perform an input check for manual user entries as well as for data that will be collected from an external device. In this article we present an approach performing the double entry method on data provided by the hardware instrument in order to investigate possible influences on the raw data by the handling CDS.
A software tool has been written which allows us to communicate with a high-performance liquid chromatography (HPLC) detector and acquire data from it. The communication is completely independent of a CDS which is started separately and connected to the same system. Using this configuration we made a parallel data acquisition of two instances at the same time possible. Two CDSs have been tested and for at least one of them it has been shown that a comparison of the acquired data can be done as with the double entry method for the data verification. For the second CDS we checked whether it would be applicable after a few modifications. The given approach could be either used for a live data verification of produced raw data or as a single test during a software operational qualification to verify the data acquisition functionality of the software
Study on intracellular delivery of liposome encapsulated quantum dots using advanced fluorescence microscopy
Quantum dots increasingly gain popularity for in vivo applications. However, their delivery and accumulation into cells can be challenging and there is still lack of detailed information. Thereby, the application of advanced fluorescence techniques can expand the portfolio of useful parameters for a more comprehensive evaluation. Here, we encapsulated hydrophilic quantum dots into liposomes for studying cellular uptake of these so-called lipodots into living cells. First, we investigated photophysical properties of free quantum dots and lipodots observing changes in the fluorescence decay time and translational diffusion behaviour. In comparison to empty liposomes, lipodots exhibited an altered zeta potential, whereas their hydrodynamic size did not change. Fluorescence lifetime imaging microscopy (FLIM) and fluorescence correlation spectroscopy (FCS), both combined with two-photon excitation (2P), were used to investigate the interaction behaviour of lipodots with an insect epithelial tissue. In contrast to the application of free quantum dots, their successful delivery into the cytosol of salivary gland duct cells could be observed when applying lipodots. Lipodots with different lipid compositions and surface charges did not result in considerable differences in the intracellular labelling pattern, luminescence decay time and diffusion behaviour. However, quantum dot degradation after intracellular accumulation could be assumed from reduced luminescence decay times and blue-shifted luminescence signals. In addition to single diffusing quantum dots, possible intracellular clustering of quantum dots could be assumed from increased diffusion times. Thus, by using a simple and manageable liposome carrier system, 2P-FLIM and 2P-FCS recording protocols could be tested, which are promising for investigating the fate of quantum dots during cellular interaction
Synergy of Chemo- and Photodynamic Therapies with C60 Fullerene-Doxorubicin Nanocomplex
A nanosized drug complex was explored to improve the efficiency of cancer chemotherapy, complementing it with nanodelivery and photodynamic therapy. For this, nanomolar amounts of a non-covalent nanocomplex of Doxorubicin (Dox) with carbon nanoparticle C60 fullerene (C60) were applied in 1:1 and 2:1 molar ratio, exploiting C60 both as a drug-carrier and as a photosensitizer. The fluorescence microscopy analysis of human leukemic CCRF-CEM cells, in vitro cancer model, treated with nanocomplexes showed Dox’s nuclear and C60’s extranuclear localization. It gave an opportunity to realize a double hit strategy against cancer cells based on Dox’s antiproliferative activity and C60’s photoinduced pro-oxidant activity. When cells were treated with 2:1 C60-Dox and irradiated at 405 nm the high cytotoxicity of photo-irradiated C60-Dox enabled a nanomolar concentration of Dox and C60 to efficiently kill cancer cells in vitro. The high pro-oxidant and pro-apoptotic efficiency decreased IC50 16, 9 and 7 × 103-fold, if compared with the action of Dox, non-irradiated nanocomplex, and C60’s photodynamic effect, correspondingly. Hereafter, a strong synergy of therapy arising from the combination of C60-mediated Dox delivery and C60 photoexcitation was revealed. Our data indicate that a combination of chemo- and photodynamic therapies with C60-Dox nanoformulation provides a promising synergetic approach for cancer treatment
Betrachtung von neuartigen Antriebs- und Kraftstoffkonzepten mit dem Ziel der Konzeption einer Hybridtankstelle für den Flugplatz Schönhagen für die Versorgung von Luftfahrzeugen mit nachhaltigen Kraftstoffen
Dieser wissenschaftliche Beitrag befasst sich zunächst mit der Betrachtung von neuartigen und nachhaltigen Antriebs- und Kraftstoffkonzepten für den Einsatz in der Luftfahrt, die zum Erreichen der hochgesteckten Klimaschutzziele auf nationaler, europäischer und internationaler Ebene beitragen sollen. Um die Energieversorgung dieser Luftfahrzeuge gewährleisten zu können, wurde ein Tankstellensystem beispielhaft für den Flugplatz Schönhagen konzipiert, welches Strom, Wasserstoff und Power-to-Liquid-Kraftstoff für Elektro-, Wasserstoff- und Luftfahrzeuge mit konventionellem Verbrennungsmotor sowie für Hybridflugzeuge zur Verfügung stellen soll. Ziel dieses Konzeptes ist die komplette Eigenproduktion der Kraftstoffe auf dem Flugplatz. Hierzu wurden rechtliche, wirtschaftliche und vor allem technische Voraussetzungen untersucht und ausgewertet sowie Berechnungen bezüglich der benötigten Kraftstoff- und Stromkapazitäten durchgeführt.This paper will initially focus on novel and sustainable propulsion and fuel concepts for use in aviation, which should contribute to the achievement of ambitious climate protection goals at national, European an international level. To ensure the energy supply of these aircrafts, a filling station system was designed as an example for the Schönhagen airfield, which provides electricity, hydrogen and power-to-liquid-fuel for electric and hydrogen driven aircrafts, aircrafts with conventional combustion engines as well as for hybrid aircrafts. The aim of this concept is the complete in-house production of fuels on the airfield. For this purpose, legal, economic, and above all technical requirements, were examined and evaluated and calculations were carried out regarding the required fuel and power capacities
A New Triple System DNA-Nanosilver-Berberine for Cancer Therapy
The isoquinoline quaternary alkaloid Berberine possesses a variety of pharmacological properties that suggests its promising application for an anticancer delivery system design utilizing its ability to intercalate DNA.In the current work we have investigated the effects of Berberine on the human T-cell leukemia cell line in vitro.Fluorescent microscopy of leukemic cells revealed Berberine nuclear localization. The results showed that Berberine inhibited leukemic cell growth in a time-and dose-dependent manner, that was associated with reactive oxygen species production intensification and caspase 3/7 activity increase with followed apoptosis induction.Berberine was used as a toxic and phototoxic agent for triple system synthesis along with DNA as a carrier and nanosilver as a plasmonic accelerator of Berberine electronic transitions and high energy emission absorbent centers.The proposed method allows to obtain the complex of DNA with Berberine molecules and silver nanopoarticles. The optical properties of free components as well as their various combinations, including the final triple system DNA-Nanosilver-Berberine, were investigated. Obtained results support the possibility to use the triple system DNA-Nanosilver-Berberine as an alternative therapeutic agent for cancer treatment
Optical Biosensors Based on Silicon-On-Insulator Ring Resonators: A Review
Recent developments in optical biosensors based on integrated photonic devices are reviewed with a special emphasis on silicon-on-insulator ring resonators. The review is mainly devoted to the following aspects: (1) Principles of sensing mechanism, (2) sensor design, (3) biofunctionalization procedures for specific molecule detection and (4) system integration and measurement set-ups. The inherent challenges of implementing photonics-based biosensors to meet specific requirements of applications in medicine, food analysis, and environmental monitoring are discussed
Zukunftsperspektiven für den IT-Mittelstand in Deutschland : Fachkräftesituation und neue Arbeitsformen : Dokumentation zum Foresightprozess
Um eine langfristige Wettbewerbsfähigkeit von Unternehmen zu sichern, werden strategische Planungsprozesse durchgeführt. Während Großunternehmen häufig in strategischen Planungsabteilungen die langfriste Ausrichtung des Unternehmens regelmäßig und in strukturierten Prozessen auf den Prüfstand stellen, ist es für kleine und mittlere Unternehmen (KMU) deutlich schwieriger, Ressourcen und Methoden-Knowhow für strategische Planungsprozesse einzusetzen; häufig überwiegt bei diesen Unternehmen der Fokus auf das operative Geschäft. Daher unterstützt das "Kompetenzzentrum IT-Wirtschaft" KMU mit einem Foresightprozess. Die vorliegende Dokumentation umfasst die Ergebnisse des offenen und unternehmensübergreifenden Foresightprozesses zur Zukunft der mittelständischen IT-Wirtschaft in Deutschland, der im Zeitraum von August 2018 bis September 2019 realisiert wurde. Ziel dieses offenen Foresightprozesses ist es, kleinere und mittlere IT-Unternehmen für mögliche Zukünfte zu sensibilisieren und Grundlagen für ihre strategische Arbeit zu liefern. Gleichzeitig soll im Rahmen der Aktivitäten des KIW der Foresightprozess auch einen Beitrag leisten, um den gesellschaftlichen Dialog zwischen Wissenschaft, Wirtschaft, Verwaltung und Politik zu Folgen der Digitalisierung für den IT-Mittelstand und die Rolle des IT-Mittelstandes als Motor der Digitalisierung anderer Branchen zu forcieren
Analyse der Katalogisierungssituation in Öffentlichen Bibliotheken Sachsen-Anhalts, sowie der Möglichkeiten von kostenfreien Datenübernahmen in nicht cloudbasierten Bibliotheksmanagementsystemen
Öffentliche Bibliotheken sind in Deutschland oft nicht an eine kooperative Katalogisierung in Bibliotheksverbünden angebunden. Durch die Einführung der Katalogisierungsregeln RDA, den Umstieg auf das Datenformat MARC21, aber auch durch die Freigabe der Metadaten einiger Bibliotheksverbünde und der DNB über eine CC0-Lizenz haben sich die grundlegenden Bedingungen der Katalogisierungsarbeit wesentlich verändert. Die Analyse einer durchgeführten Onlineumfrage beantwortet die Frage, ob die hauptamtlich geführten Öffentlichen Bibliotheken des Bundeslandes Sachsen-Anhalts diese Umstellung vollzogen haben. In Expertengesprächen wurden die technischen Möglichkeiten der eingesetzten Bibliotheksmanagementsysteme abgefragt und den Antworten der Bibliotheken gegenübergestellt.
Die Ergebnisse zeigen, dass bei einer großen Anzahl der Bibliotheken die Umstellung auf die neuen Anforderungen noch nicht vollzogen wurde und die neuen Möglichkeiten der Fremddatenübernahme häufig nicht genutzt werden oder nicht bekannt sind.
In einem Konzeptvorschlag ist eine mögliche Vorgehensweise für eine Verbesserung der derzeitigen Situation im Zusammenhang mit der Umgestaltung des ÖVK ausgearbeitet.
Dieses Konzept wird ergänzt durch Anleitungen und Leitfäden, in denen exemplarisch die möglichen Fremddatenübernahmen gezeigt werden
Quantification of nitroaromatic explosives in contaminated soil using MALDI-TOF mass spectrometry
Contamination from various sources is a global environmental and health threat, with mining and military activities in particular having spread nitroaromatic compounds, such as 2,4,6-trinitrotoluene and its degradation products and by-products, to the soil. The investigation and monitoring of large contaminated areas requires new detection methods since the established ones are expensive and time-consuming. Hence, we established a matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI--TOF MS) method using 1,5-diaminonaphthalene as the matrix substance and an internal standard for quantification. Analyzing standard substances, we found specific signals for radical and fragment ions of different nitrotoluenes and nitrobenzenes with good reproducibility and detection limits down to 0.25 ng/μL. The analysis of soil sample extracts from a former production site showed clear signals for 2,4,6-trinitrotoluene and the primary degradation products aminodinitrotoluenes. Furthermore, quantification gave results comparable to those obtained by conventional liquid chromatography--tandem mass spectrometry analysis. The MALDI-TOF MS method has a comparatively lower reproducibility, with relative standard deviations of 6% to 20% for multiple measurements of standard solutions and soil sample extracts. Nevertheless, a comparison of both methods revealed the advantages of MALDI-TOF MS analysis of explosive-contaminated areas with regard to costs, time, and handling. Finally, our MALDI-TOF MS method fulfills all the needs for high sample throughput and can therefore be a valuable screening tool for explosive-contaminated areas