End-to-end approach for the characterization and control of product-related impurities in T cell bispecific antibody preparations.
Int J Pharm X
; 5: 100157, 2023 Dec.
Article
en En
| MEDLINE
| ID: mdl-36687375
Antibody manufacturing process; CE-SDS, capillary electrophoresissodium dodecyl sulfate; CRS, cytokine release syndrome; ELISA, enzyme-linked immunosorbent assay; End-to-end approach; Fc, fragment crystallizable; Functional characterization; GMP, good manufacturing process; HIC, hydrophobic interaction chromatography; HMW, high molecular weight (species); IEX, ion exchange chromatography; PBS, phosphate buffer saline; Product-related impurities control; SEC, size-exclusion chromatography; SPR, surface plasmon resonance; TAA, tumor-associated antigen; TCB, T cell bispecific; TCR, T cell receptor
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MEDLINE
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En
Revista:
Int J Pharm X
Año:
2023
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Article
País de afiliación:
Alemania