Cdmo Services ad currus - T cellulis - India Ind
SERVITIUM
| CDmo Services pro currus - T cellulis (HICELX®Platform) | ||||
| Genimen | SERVITIUM | |||
| India Ind | 1 | Processus et test ratio progressionem |
● Post Project Requirements (Subject ut customized mutationes) |
● Full - GMP obsequium officina B + a gradu cum unidirectional aer fluxus ● GMP qualitas Management System ● pluribus felix submissionibus in Sina |
| 2 | GMP vestibulum currus - T cellulis |
● 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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| 3 | Testing of Car / TCR - T Cellulae |
● puritate (CD3 +) ● CD4 / CD8 ● Car / TCR positivum rate ● RCL (celeri test) ● numerus of copies ● sterilitatem (Compppendial modum) ● sterilitatem (celeri test) ● Mycoplasma (Compendium) ● Mycoplasma (celeri test) ● endotoxin |
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| 4 | Ratio Validation |
● specialitas ● accurate ● praecisione ● linearity et range ● Lod |
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| 5 | Stabilitatem studio |
● diu - terminus stabilitatem ● accelerated stabilitatem ● accentus temptationis ● shipping stabilitatem |
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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
Project Management Plan
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.
