Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 164 |
| INN | Trinbelimab |
| Status | Approved |
| Drug code(s) | None |
| Brand name | Rhoclone |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | lambda |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | Rhesus D |
| Indications of clinical studies | Haemolytic disease of newborn |
| Primary therapeutic area | Cardiovascular / hemostasis disorders |
| Most advanced stage of development (global) | Approved India |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | July 01, 2003 |
| Start of Phase 2 | |
| Start of Phase 3 | |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | 2010 |
| Date of first US approval | |
| INN, US product name | Trinbelimab |
| US or EU approved indications | None |
| Company | Bharat Serums and Vaccines (Maharashtra India) |
| Licensee/Partner | None |
| Comments about company or candidate | Oct 2018: Bharat Serum and Vaccines completes a phase II/III trial for Haemolytic disease of newborn (Prevention) in India (IM) (CTRI/2017/03/008101). Approval in 2010 is estimated. Clinical Trials Registry of India Identifier: CTRI/2017/03/008101. Compares recominant to hybridoma produced monoclonals ( Most of these limitations were addressed by the introduction of monoclonal anti-D (Mono anti-D), manufactured using the hybridoma technique. A commercial preparation (Rhoclone®) is available in some countries, including India. The antibody genes from this hybridoma were isolated and introduced in Chinese hamster ovarian cells (CHO), thus enabling the cells to express recombinant anti-D (R-anti-D).) Obstetrics & Gynecology Science 2020;63(3):315-322. https://www.ogscience.org/journal/view.php?number=8527 |
| Full address of company | 3rd Floor, Liberty Towers, Plot No. K-10,
Behind Reliable Plaza, Kalwa Industrial Estate, Airoli, Navi Mumbai 400708 Asia India https://bsvgroup.com/contact/ |
immunoglobulin G1-lambda3, anti-[Homo sapiens RHD (Rhesus blood group D antigen, RhD, CD240D)], Homo sapiens monoclonal antibody; Recombinant version produced in CHO (Chinese Hamster Ovary) dihydrofolate reductase (DHFR)-deficient cells; marketed product from hybridoma. In-house development of monoclonal Anti-D was initiated in 2003. Traditional method involving EBV transformation of human B- cells was employed to generate hybridomas secreting Anti-D. Several hundreds of clones were screened for biological activity and other properties before the clones were selected for clinical development. The final hybridoma clone for clinical application was selected and the cell banks were established and characterized for safety as per ICH guidelines at Charles River Laboratory, USA. The cells producing Anti-D immunoglobulin are grown in bioreactor using micro carrier beads. The antibody secreted by the cells is purified by a series of chromatographic methods followed by nano filtration to give the final purified bulk API. The purified bulk API bulk is further formulated to give the final product-Rhoclone. https://indiankanoon.org/doc/54798880/
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |