Satumomab Concentrate (For Further Manufacturing Use) - Tumor Associated Glycoprotein-72 Mab, conc.
Status: withdrawn from the market; intermediate only
Organizations involved:
Lonza Biologics plc – Manuf.; R&D; Tech.; Former
Cytogen Corp. – Manuf. other
EUSA Pharma Ltd. – Parent
Jazz Pharmaceuticals Inc. – Parent
National Cancer Inst. (NCI) – R&D; Tech.; Former
National Institutes of Health (NIH) – Parent
Celltech Biologics plc – Former
Cross ref: See the entry (#314) for satumomab pendetide (Onco-Scint CR/OV), which is manufactured from this intermediate bulk product. See the entry for Monoclonal Antibodies (#300).
Description: Satumomab Concentrate (For Further Manufacturing Use) is a concentrate of B72.3 murine monoclonal antibody manufactured by Lonza Biologics plc exclusively for further manufacture of satumomab pendetide (OncoScint CR/OV) by Cytogen Corp. Satumomab (B72.3) is a murine monoclonal antibody with specificity for tumor associated glycoprotein-72 (TAG-72), a cellular antigen associated with ovarian and other carcinomas. Satumomab Concentrate is manufactured by large-scale cell culture of the B72.3 murine hybridoma, followed by multiple protein isolation and chromatographic separation procedures.
Nomenclature: TAG-72 Mab, conc. [BIO]; Satumomab Concentrate (For Further Manufacturing Use) [FDA]; Satumomab [USAN INN BAN]; anti-(human tumor-associated glycoprotein 72) immunoglobulin G1 (mouse monoclonal B72.3 chain) disulfide with mouse monoclonal B72.3 light chain, dimer [CAS]; 144058-40-2 [CAS RN]; B72.3 [SY]; CYT-099 [SY]; TAG-72 monoclonal antibody [SY]; Anti-TAG-72 monoclonal antibody [SY]; tumor associated glycoprotein-72 Mab, conc. [SY]
Companies.: Satumomab Concentrate (For Further Manufacturing Use) is manufactured by Lonza Biologics plc (Slough, Berkshire, U.K.), CBER/FDA est. no. 1209; formerly Celltech Biologics plc, CBER/FDA est. no. 1169; originally Celltech Ltd., CBER/FDA est. no. 0947. Purified bulk B72.3 monoclonal antibody is produced by Lonza under a shared manufacturing agreement with Cytogen Corp. The product is provided exclusively to Cytogen Corp. Onco-Scint CR/OV. Cytogen discontinued OncoScint CR/OV at the end of 2002. In May 2008, EUSA Pharma completed acquisition of Cytogen for $22.6 million. In July 2012, Jazz Pharmaceuticals acquired EUSA Pharma.
Dr. J. Schlom, et al., National Cancer Institute, National Institutes of Health, originally developed the B72.3 monoclonal antibody/hybridoma.
Manufacture: The B72.3 hybridoma cell line was developed by immunizing a BALB/c mouse with a membrane-enriched extract from a metastatic liver sample taken from a patient with breast adenocarcinoma. Spleen cells from the mouse were fused with NS-1 murine myeloma cells and the resulting hybridomas were screened for selective reactivity against breast cancer extracts (CEA). The B72.3 hybridoma secreting a murine IgG1 kappa with desired specificity was selected, rigorously cloned by limiting dilution, and used to prepare a Master Cell Bank (MCB) and manufacturer’s Working Cell Bank (MWCB). Both cell banks have been shown to be free of adventitious agents, including exogenous bacteria, mycoplasma, fungi, and viruses.
Lonza Biologics uses serum-free fermentation in air-lift bioreactors for large-scale cell culture of the B72.3 hybridoma. Lonza is reported to be the only large-scale biopharmaceutical manufacturer currently using air-lift bioreactors. Purification is by sequential protein isolation and chromatographic separation procedures.
The manufacturing process for satumomab (B72.3 monoclonal antibody) has been validated for removal of DNA, cell culture medium additives, process reactants, and for viral inactivation and removal. Non-infectious murine retrovirus particles (types A and C) have been detected in the cell banks by microscopy. The purification steps have been validated for removal of these viruses. Each lot is tested for mycoplasma, murine retroviruses, adventitious viruses (human and mouse), endotoxin, and sterility.
The overall manufacturing process for the monoclonal antibody appears to be very similar to that of capromab (ProstaScint) for which more details are provided.
FDA class: Biologic PLA
CBER class: Blood And Blood Derivatives
Approvals: Date = 19921229; first approval, PLA, granted to Celltech Ltd.
Date = 19940201; PLA licenses revoked and granted (reissued) to Celltech Biologics plc, new owner/co. name
Date = 19961122; PLA approval revoked and granted (reissued) to Lonza Biologics plc, new owner
Indications: [unofficial text]: further manufacture of OncoScint CR/OV
Status: Cytogen discontinued OncoScint CR/OV effective Dec. 31, 2002. The product is no longer marketed and no longer appears on FDA approval lists. This intermediate was exempt from CBER/FDA lot release requirements.
Tech. transfer: Cytogen Corp. exclusively licensed patents from the National Cancer Institute, National Institutes of Health (NIH; Bethesda, MD; license no. L-180-91) including U.S. 4,612,282, “Monoclonal Antibodies Reactive with Human Breast Cancer,” Schlom, J. et al. (National Cancer Institute), issued September 16, 1986, and assigned to NIH. This and related patents cover various monoclonal antibodies, including murine B72.3, which selectively react with mammary carcinoma cell antigens, including tumor associated glycoprotein-72 (TAG-72), and associated hybridoma cell lines. Monoclonal antibodies are produced by hybridoma cell lines formed by fusing splenic lymphocytes from carcinoma-immunized mice with the NS-1 murine myeloma cell line.
Companies involvement:
Full monograph
313 TAG-72 Mab, conc.
Nomenclature:
TAG-72 Mab, conc. [BIO]
Satumomab Concentrate (For Further Manufacturing Use) [FDA]
Satumomab [USAN INN BAN]
anti-(human tumor-associated glycoprotein 72) immunoglobulin G1 (mouse monoclonal B72.3 ?1-chain) disulfide with mouse monoclonal B72.3 light chain, dimer [CAS for satumomab]
144058-40-2 [CAS RN]
Anti-TAG-72 monoclonal antibody [SY]
B72.3 [SY]
CYT-099 [SY]
TAG-72 monoclonal antibody [SY]
Tumor Associated Glycoprotein-72 Mab, conc. [SY]
FDA Class: Biologic PLA
Year of approval (FDA) = 1992
Date of 1st FDA approval = 19921229
(in format YYYYMMDD)
Index Terms:
antibodies (see also immune globulins; monoclonal antibodies)
biopharmaceutical products
intermediate/precursor products
monoclonal antibodies
murine (mouse) materials used
murine (mouse) monoclonal antibodies
air-lift fermenters
B72.3 hybridoma cells
bioreactors, 10,000 Liter
mammalian cell culture
murine myeloma cells
NS-1 murine myeloma cells
rodent cells <!-- rodentcells -->
rodent cells <!-- rodentcells -->
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
exempt from CBER lot release requirements
North American coral snake
North American coral snake
EU011 Approved Formerly in EU/withdrawn
UM999 Not Available/Not Marketed in US
US011 Approved Formerly in US/withdrawn
EM999 Not Available/Not Marketed in EU
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