Bulk harvest
Serbian translation: prikupljanje grupe materijala/ žetva (iz) jedne serije/šarže
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| 13:40 Dec 16, 2023 |
| English to Serbian translations [PRO] Medical - Medical (general) / Pharmaceuticals | |||||||
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|  Selected response from: Lingua 5B Bosnia and Herzegovina Local time: 16:20 | ||||||
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| 3 | žetva (iz) jedne serije/šarže |
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| bulk harvest, english explanation |
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Answers
1 day 31 mins confidence: 
| bulk harvest žetva (iz) jedne serije/šarže Explanation: Single virus harvest: A virus suspension harvested from production cell cultures that were processed together. Multiple harvests from the same production cell culture may be pooled and considered a single virus. • Materijali za obuku kirurga i kirurškog osoblja sadržavat će sljedeće ključne elemente: o podatke o lijeku Spherox, uključujući trenutačno odobrene indikacije i zakonsku osnovu o detaljan opis postupka biopsijske žetve (engl. biopsy harvest procedure) i postupka primjene lijeka, implantacije artrotomijom koljena te p What is bulk harvest testing? We provide lot release testing solutions to meet the requirements of your biologic for preclinical and clinical studies, as well as licensed biologics. Bulk harvest is the batch of materials taken from a bioreactor during the manufacture of a biologic. Žetva virusa kultiviranog u jajima https://ec.europa.eu/health/documents/community-register/201... |
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Reference comments
8 hrs |
| Reference: bulk harvest, english explanation Reference information: sigmaaldich...The Note for Guidance on Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin1, states that a safety testing program is dependent on three critical aspects: • testing of the starting materials, including the cell banks • testing of the in-process intermediates, typically the ***bulk harvest** • evaluation of the viral inactivation and/or removal capacity of the downstream purification process searching document by word BULK,,,Once the manufacturing process has been scaled up and ready for commercialization, it is recommended that RVLPs be quantitated in the unprocessed bulk harvest material. Data from at least three lots of bulk harvest are required for submission to the regulatory authorities. This technical note will provide the scientific and regulatory landscape for key methods which are applied to ensure safety of such recombinant proteins, with a focus on alternate and superior methods to the standard transmission electron microscopy (TEM) method. Page 2 Assays to Quantitate RVLPs in Unprocessed Bulk Quantitative transmission electron microscopy (TEM) analysis has historically been the method of choice to quantitate retroviral particles in volumes of unprocessed bulk harvest (UPBH) supernatant. This method, which requires concentration of the sample to provide adequate assay sensitivity, is highly variable and in spite of the sample concentration, -------------------------------------------------- Note added at 8 hrs (2023-12-16 22:39:03 GMT) -------------------------------------------------- link https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/mar... -------------------------------------------------- Note added at 9 hrs (2023-12-16 23:00:52 GMT) -------------------------------------------------- link https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/mar... -------------------------------------------------- Note added at 9 hrs (2023-12-16 23:02:01 GMT) -------------------------------------------------- try link again https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/mar... https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/252/547/quantitation-of-retrovirus-like-particles-in-cho |
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