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English to Russian: Manufacturing process validation/Валидация производственного процесса General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - English It has previously been demonstrated in a development study (Tchessalov et al, Patent application, US2010/0041870 A1, Feb 2010) that when 10 mg/ml Enbrel drug product was lyophilized aggressively (Primary drying shelf temperature 25°C, Vacuum 500 mT), the product temperature during primary drying increased up to -9.8°C (calculated value). The actual maximum product temperature during this cycle increased to -10.5°C before the thermocouple lost contact with ice. This is well above the Tg’ and is close to the formulation melting point, Tm. Despite these aggressive process conditions, all of the vials still had an acceptable cake appearance. Vials from this cycle were then enrolled in a 12 month stability study for storage at 2-8°C, 25°C, and 40°C along with samples from a conservative drying process (performed below Tg’). The formation of high molecular weight species (the major mechanism of degradation of Enbrel in lyophilized state) was monitored for both Enbrel materials and showed lower increase in high molecular weight species for the material from aggressive cycle. This data demonstrated that Enbrel 10 mg/ml is capable of withstanding aggressive cycle conditions without compromising product quality.
Translation - Russian Ранее в проектном исследовании (Чессалов и другие, заявка на патент, US2010 / 0041870 A1, февраль 2010 г.), что, при ускоренной лиофилизации лекарственного препарата Энбрел, 10 мг / мл (температура полки при первичной сушке 25 ° С, вакуум 500 мТорр), температура продукта в ходе первичной сушки увеличивается до -9.8 ° C (рассчитанное значение). Фактическая максимальная температура продукта в течение этого цикла увеличилась до -10.5 ° C, прежде чем термопара потеряла контакт со льдом. Это значительно выше температуры стеклования Tg и находится близко к точке плавления продукта Tm. Несмотря на ускоренные условия процесса, во всех флаконах все еще наблюдался приемлемый внешний вид лиофилизата. Флаконы из этого цикла затем поступили на 12 месячное исследование стабильности для хранения при температуре 2-8 °С, 25 °С и 40 °С вместе с образцами, полученными при умеренном процессе сушки (проведенного ниже температуры стеклования Tg). Образование высокомолекулярных соединений (основной механизм деградации препарата Энбрел в лиофилизированном состоянии) контролировали для обоих образцов препарата Энбрел, и образцы после ускоренного цикла показали меньшее увеличение количества высокомолекулярных соединений. Эти данные показали, что препарат Энбрел, 10 мг/мл, способен выдерживать ускоренные условия цикла без ухудшения качества продукта.
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Years of experience: 23. Registered at ProZ.com: Oct 2015.
English to Russian (Peoples' Friendship University of Russia) Russian to English (Peoples' Friendship University of Russia)
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N/A
Software
Adobe Acrobat, Adobe Photoshop, Microsoft Excel, Microsoft Office Pro, Microsoft Word, Powerpoint
Bio
Medical and pharmaceutical translation eng/rus, rus/eng.
Translation of individual and general pharmacopoeial monographs (EP, USP, JP)
Translation of validation documentation (analytical procedures, equipment), manufacturing process descriptions, guidelines and instructions on manufacturing and analytical equipment, parts of CTD etc.
Translation of Contract Manufacturing agreements, Technical Quality Agreements, Letters of Intents, Non-disclosure agreements, etc.
Translation of QC, QA documentation
Translation of technology and analytical transfer documentation
Translation of Clinical and stability studies
Keywords: pharmaceutical, manufacturing, engineering, drug product, quality assurance, quality control, validation, technical agreement, non-disclosure agreement, localization. See more.pharmaceutical, manufacturing, engineering, drug product, quality assurance, quality control, validation, technical agreement, non-disclosure agreement, localization, software, software validation, russian, english, contract manufacturing, API, SAP, Pharmacopoeia, EP, USP, GMP, good manufacturing practice, good distribution practice, GDP. See less.
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