Cdmo Services ad currus - T cellulis - IITI gradu / non - Volume Phase
SERVITIUM
| CDmo Services pro currus - T cellulis (HICELX®Technology Platform) | ||||
| Genimen | SERVITIUM | |||
| Iit gradu | 1 | Dossier Praeparatio |
● ethica approbatione ● HGrac Approbatio |
● seamless nexu ad indeminess ● GMP - sicut officina ● authentica et Traceable Documentation ● GMP - sicut qualitas administratione ratio ● fabrica 200 batches |
| 2 | Processus progressionem |
● Post Project Requirements (Subject ut customized mutationes) |
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| 3 | Processum sanationis |
● Faciens ad III continuati batches, occurrens consilium consilium requisita et cubits |
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| 4 | Repono stabilitatem |
● Post Project Requirements (Subject ut customized mutationes) |
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| 5 | Shipping stabilitatem |
● Post Project Requirements (Subject ut customized mutationes) |
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| 6 | Cell vestibulum et testis (GMP - amo) |
● Connectens Shipment ● Productio scale: CC ml ~ XX l (subiectum ut customized mutationes) ● Processus Route: flexibile processus consilium et subiectum ad customized mutationes |
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Commoda
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Commoda usura nostrum HICELX® Technology Platform: • usura independenter developed cryopreri cell praeparatio • usura clausa et automated cell cultus apparatu, idem quod global amet societates • Cell Officina obsequium cum orci et commercial requisitis: Grades B + A, unidirectional Aeris fluxus, plenus - GMP • cell from fronde cum altior rate, solvitur exitibus de humilis positivum rate et proliferation rate • mollius idoneam ad vestibulum et temptationis de variis cellular therapy products • extensive experientia per usura et clausa et automated cell culturing apparatu • Usus in vestibulum 200 IIT C. Exempla • Usus in Indicium de currus - T cellula productum, quod prospere probatus a NMPA • Usus in supporting in technology serie orci batch of currus - T cellula products et in vestibulum cell exempla pro orci usus |
Processu
Imperium
| Genimen | Test item | Test modus |
| Probat exercitatione | Species | Visual inspectionem |
| pH | Modus DCXXXI de CHP MMXX | |
| Osmolality | Modus DCXXXII de CHP MMXX | |
| Cellular characteres / munera | Cellula comites | PRAEFLUDIUM |
| Cellula viability | PRAEFLUDIUM | |
| Currus positive rate | Fluunt Cytometry | |
| Immune CELLA Compositionem | Fluunt Cytometry | |
| Cytokine secretio | Elisa | |
| Cytotoxicity | Sicut per protocol | |
| Inmunditia | RELICTUM Culture Supplement | Fretus supplementum type |
| RELICTUM Magnetic Bead comitem | Microscopy | |
| Salus | Numerus car gene copies | Q - PCR |
| Endotoxin temptationis | Modus MCXLIII de CHP MMXX | |
| Sterilitatem temptationis |
Celeriter Testing |
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| Modus MCI de CHP MMXX | ||
| Mycoplasma temptationis | Q - PCR | |
| Modus MMMCCCI de CHP MMXX | ||
| Rcl | Q - PCR |
Project Timeline
Hebgene Project Management Team, constans chishistae, project managers, project QA et GMP peritorum, et faciet studium ut lenis et sonus operationem et singulis et omni GMP project.
