21 research outputs found
Ways to improve the results of reconstructive plastic surgery after hand injuries
The purpose of the study is to improve the treatment results after reconstructive plastic operation of the hand. A complex of preoperative adaptive preparation and a rational postoperative rehabilitation, improving regional and peripheral blood circulation in the area of surgical intervention, has been developed. The complex has been applied to 286 patients, 92% of cases have positive long-term results of medical rehabilitation.Цель исследования - улучшение исходов лечения после реконструктивно-пластических операций на кисти. Разработан комплекс предоперационной адаптивной подготовки и рациональной послеоперационной реабилитации, улучшающий региональное и периферическое кровообращение в зоне оперативного вмешательства. Комплекс применён у 286 пациентов. В 92% случаев получены положительные отдалённые результаты восстановительного лечения
Методические подходы к валидации технологических процессов получения терапевтических рекомбинатных белков на основе концепции «Quality by Design»
Validation of production processes based on the Quality by Design (QbD) principles calls for thorough scientific understanding of the processes and enhancement of their stability by implementation of new technologies. The aim of the study consisted in substantiating a QbD-based technological approach to validation of commercial production of dornase alfa. For this purpose a design space was established in a scale-down model, i.e. 2 L reactors; the model was shown to be representative in terms of all parameters except for the reactor size; the similarity of hydrodynamic conditions, design characteristics and operation modes of laboratory, pilot and commercial scale reactors was established; the process scalability was demonstrated by using the PCA (Principal Component Analysis) multivariate mathematical model including the volume range of 2–1000 L, input and output process parameters and product quality attributes for a number of recombinant therapeutic products derived from the same CHO cell line and expression construction as dornase alfa producer. The article demonstrates the applicability of engineering space, which includes bioreactor design features and production process parameters, to different production scales by implementing 3 processes at the pilot scale (100 L) and 2 processes at the commercial scale (1000 L) and building a PCA model based on the obtained data.Валидация технологических процессов на основе концепции «качество, встроенное при разработке» (Quality by Design, QbD) требует глубокого научного понимания процессов и повышения их устойчивости путем внедрения новых технологий. Цель данной работы заключалась в обосновании методологического подхода на основе концепции QbD к валидации промышленного производства активной фармацевтической субстанции (АФС) дорназы альфа. Для этого было определено технологическое пространство процесса в демасштабированной модели — реакторах объемом 2 л; доказана репрезентативность данной модели по независимым от масштаба реактора параметрам; установлено сходство гидродинамических условий, конструкционных особенностей и режимов работы реакторов лабораторных, опытно-промышленных и промышленного объемов; показана масштабируемость процесса посредством демонстрации многовариантной математической модели РСА (Principal Component Analysis), перекрывающей объемы 2–1000 л, включающей входные, выходные параметры процесса и параметры качества продукта для ряда продуцентов рекомбинантных терапевтических белков, созданных на основе той же клеточной линии CHO и экспрессионной конструкции, что и продуцент дорназы альфа. Обоснована применимость инженерного пространства, которое определяется сочетанием конструкционных особенностей биореакторов и технологических параметров процесса, к различным масштабам путем проведения трех процессов в опытно-промышленном масштабе 100 л и двух процессов в промышленном масштабе 1000 л и построении на основе полученных данных модели РСА
Distribution of massive sulfide and gold mineralization in the folded part of the Orenburg Urals according to materials aerospace survey
In the second half of the XX century during the Southern Urals regional geological studies GDP-50, GDP-200/2, GDP-1000/3) widely used materials aerial and satellite imagery. Interpretation of these materials revealed widespread in the region lineaments and ring systems morphostructures. Comparison of materials of aerospace survey with different scale geological maps showed that all deposits and most of the occurrences of copper pyrite ore placed on ring morphostructures area that allows us to consider them as additional search features in planning and carrying out of prospecting works. Manifestations of gold confined to the lineament and fault zones
Methodological Approaches to Validation of Therapeutic Recombinant Proteins Production Based on the Quality by Design Concept
Validation of production processes based on the Quality by Design (QbD) principles calls for thorough scientific understanding of the processes and enhancement of their stability by implementation of new technologies. The aim of the study consisted in substantiating a QbD-based technological approach to validation of commercial production of dornase alfa. For this purpose a design space was established in a scale-down model, i.e. 2 L reactors; the model was shown to be representative in terms of all parameters except for the reactor size; the similarity of hydrodynamic conditions, design characteristics and operation modes of laboratory, pilot and commercial scale reactors was established; the process scalability was demonstrated by using the PCA (Principal Component Analysis) multivariate mathematical model including the volume range of 2–1000 L, input and output process parameters and product quality attributes for a number of recombinant therapeutic products derived from the same CHO cell line and expression construction as dornase alfa producer. The article demonstrates the applicability of engineering space, which includes bioreactor design features and production process parameters, to different production scales by implementing 3 processes at the pilot scale (100 L) and 2 processes at the commercial scale (1000 L) and building a PCA model based on the obtained data
Local variations of bulk hydrogen and chlorine-equivalent neutron absorption content measured at the contact between the Sheepbed and Gillespie Lake units in Yellowknife Bay, Gale Crater, using the DAN instrument onboard Curiosity
Data gathered with the Dynamic Albedo of Neutron (DAN) instrument onboard rover Curiosity were analyzed for variations in subsurface neutron flux and tested for possible correlation with local geological context. A special DAN observation campaign was executed, in which 18 adjacent DAN active measurements were acquired every 0.75-1.0 m to search for the variations of subsurface hydrogen content along a 15 m traverse across geologic contacts between the Sheepbed and Gillespie Lake members of the Yellowknife Bay formation. It was found that several subunits in Sheepbed and Gillespie Lake could be characterized with different depth distributions of water-equivalent hydrogen (WEH) and different chlorine-equivalent abundance responsible for the distribution of neutron absorption elements. The variations of the average WEH at the top 60 cm of the subsurface are estimated at up to 2-3%. Chlorine-equivalent neutron absorption abundances ranged within 0.8-1.5%. The largest difference in WEH and chlorine-equivalent neutron absorption distribution is found between Sheepbed and Gillespie Lake. Key Points DAN special campaign in Yellowknife Bay DAN local measurements of water and chlorine abundance Correlation of DAN measurements and geological context ©2014. American Geophysical Union. All Rights Reserved.Peer Reviewe