Monoclonal antibodies (mAbs) are now central to the burgeoning field of precision medicine in oncology. Protheragen's services for the development of antitumor monoclonal antibodies integrate advanced molecular engineering and comprehensive immuno-oncological analysis to provide biologics that are targeted, potent, and designed for effective large-scale production.
Overview of Antitumor Monoclonal Antibody
Antitumor monoclonal antibodies are designed to identify and attach to specific tumor-associated antigens (TAAs) located on the membranes of malignant cells. The mechanisms of action for these antibodies are direct as well as immune system-mediated, transforming oncology by enabling targeted cancer cell destruction with diminished collateral damage, enhanced immunological memory, and the possibility of long-lasting effects.
The effectiveness of antitumor mAbs lies in their capability to recognize and bind specific antigens that are expressed on the surface of the cancer cells. Common targets include:
- HER2 (ERBB2): Overexpressed in 15-20% of breast cancers and some gastric cancers.
- EGFR: Frequently mutated or amplified in colorectal, lung, and head-and-neck cancers.
- CD20, CD52, CD19, CD22: Immune cell surface markers in hematologic malignancies.
Because these targets are either tumor-specific or preferentially expressed on malignant cells, mAbs can separate them from normal tissue with high fidelity.
Fig.1 Immunologic mechanisms and potential of HER2-targeted mAb therapies. (Tsao L. C.,
et al., 2021)
Development of Antitumor Monoclonal Antibody
By 2025, the worldwide monoclonal antibody therapeutics market is projected to exceed USD 250 billion, with oncology accounting for over 40% of that value. There seems to be a growing bias towards ADCs and Fc-engineered derivatives with stronger approvals, which underscores a field focus on greater efficacy and specificity.
The therapeutic landscape includes:
- Fc-optimized antibodies (e.g., Margetuximab)
- Bispecific antibodies (e.g., Blinatumomab)
- Immune checkpoint modulators targeting PD-1/PD-L1 pathways
Next-generation ADCs with improved linkers and payloads
Table 1. List of FDA-approved monoclonal antibodies targeting tumor antigens. (Tsao L. C., et al., 2021)
| Antigen Category |
Antibody (INN) |
Trade Name |
Target Antigen |
IgG Type |
Year of FDA Approval |
Tumor Disease |
Major Mechanism of Action |
| Hematological cancer |
Ofatumumab |
Arzerra |
CD20 |
Human IgG1 |
2009 |
Chronic lymphocytic leukemia |
ADCP, ADCC, CDC |
| Hematological cancer |
Daratumumab |
Darzalex |
CD38 |
Human IgG1/κ |
2015 |
Multiple Myeloma |
CDC, ADCC, ADCP, neutralization |
| Hematological cancer |
Inotuzumab ozogamicin |
BESPONSA |
CD22 |
Humanized IgG4 as ADC |
2017 |
B-cell precursor acute lymphoblastic leukemia |
cytotoxic drug delivery |
| Hematological cancer |
Moxetumomab pasudotox |
Lumoxiti |
CD22 |
Murine IgG1 dsFv immunotoxin |
2018 |
Hairy-cell leukemia |
cytotoxic drug delivery |
| Hematological cancer |
Belantamab mafodotin |
BLENREP |
BCMA |
Humanized IgG1 ADC |
2020 |
Multiple Myeloma |
cytotoxic drug delivery |
| Hematological cancer |
Brentuximab vedotin |
Adcetris |
CD30 |
Chimeric IgG1 as ADC |
2011 |
Hodgkin lymphoma (HL), systemic anaplastic large cell lymphoma (ALCL) |
cytotoxic drug delivery |
| Hematological cancer |
Elotuzumab |
Elotuzumab |
SLAMF7 |
Humanized IgG1 |
2015 |
Multiple Myeloma |
ADCP, ADCC, CDC |
| Solid cancer (ErbB family) |
Trastuzumab |
Herceptin |
HER2 |
Humanized IgG1 |
1998 |
Breast cancer, gastric, or gastroesophageal junction adenocarcinoma |
ADCP, CDC |
| Solid cancer (ErbB family) |
Ado-Trastuzumab emtansine |
Kadcyla |
HER2 |
Humanized IgG1 as ADC |
2013 |
Breast cancer |
cytotoxic drug delivery |
| Solid cancer (ErbB family) |
[fam]-trastuzumab deruxtecan |
Enhertu |
HER2 |
Humanized IgG1 ADC |
2019 |
Breast cancer |
cytotoxic drug delivery |
| Solid cancer (ErbB family) |
Pertuzumab |
Perjeta |
HER2 |
Humanized IgG1 |
2012 |
Breast cancer |
signal blockade, ADCP, CDC |
| Solid cancer (ErbB family) |
Necitumumab |
Portrazza |
EGFR |
Human IgG1 |
2015 |
Non-small-cell lung carcinoma |
signal blockade, ADCC |
| Solid cancer (other targets) |
Enfortumab vedotin |
Padcev |
Nectin-4 |
Human IgG1 ADC |
2019 |
Urothelial cancer |
cytotoxic drug delivery |
| Solid cancer (other targets) |
Sacituzumab govitecan |
Trodelvy |
TROP-2 |
Humanized IgG1 ADC |
2020 |
Breast cancer |
cytotoxic drug delivery |
| Solid cancer (other targets) |
Arcitumomab |
CEA-scan |
CEA |
Murine Fab fragment |
1996 |
Colorectal cancer |
Detection (non-therapeutic) |
| Solid cancer (other targets) |
Satumomab |
OncoScint |
TAG-72 |
Murine MAb |
1992 |
Colorectal and ovarian cancers |
Detection (non-therapeutic) |
| Solid cancer (other targets) |
Capromab |
ProstaScint |
PSMA |
Murine MAb |
1996 |
Prostate adenocarcinoma |
Detection (non-therapeutic) |
Disclaimer: Protheragen focuses on providing preclinical research services. This table is for information exchange purposes only. This table is not a treatment plan recommendation. For guidance on treatment options, please visit a regular hospital.
Our Services
Protheragen offers a comprehensive suite of antitumor monoclonal antibody development services, tailored to meet the diverse needs of our clients. Our services encompass the entire development lifecycle, from target identification and validation to preclinical research.
Target Identification and Antibody Generation
Using single-cell sequencing, phage display, and CRISPR screening, we identify actionable antigens expressed selectively in tumor tissues. Antibody candidates are generated through hybridoma technology, transgenic animal platforms, or fully human libraries.
Antibody Optimization and Humanization
- High binding affinity and low off-target reactivity
- Human framework compatibility to reduce immunogenicity
- Fc-region enhancements to improve ADCC and half-life (e.g., afucosylation)
Preclinical Research
- Binding specificity via flow cytometry and SPR
- Internalization kinetics
- Cytotoxicity profiling across multiple cancer cell lines
Optional Services
|
Service Name |
Service Content |
Service Duration |
| Mouse Hybridoma Monoclonal Antibody Customization |
| Antigen Design & Prep |
Multi-peptide synthesis or recombinant protein production (optional) |
2–3 weeks |
| mRNA-LNP preparation (for difficult-to-express proteins, optional) |
2–3 weeks |
| Immunization |
Immunize 5 Balb/c mice, titer test, and serum collection |
8–10 weeks |
| Cell Fusion |
Select positive hybridoma clones |
2–3 weeks |
| Clone Screening |
Subclone positive hybridomas, stability testing |
3–4 weeks |
| Ascites Production & Purification |
Provide 2 positive subclones for ascites production and purification |
5–6 weeks |
| Human B Cell Monoclonal Antibody Preparation |
| Antigen Design & Prep |
Multi-peptide synthesis or recombinant protein production (optional) |
2–3 weeks |
| mRNA-LNP preparation (for difficult-to-express proteins, optional) |
2–3 weeks |
| Animal Immunization |
Immunization, blood collection, and antibody titer testing |
6–8 weeks |
| Single B Cell Isolation |
Isolate PBMCs from blood samples.
Prepare B cell culture medium, isolate antigen-specific single B cells, expand, and culture |
1–2 weeks |
| Antibody Gene Cloning |
Obtain VH/VL gene sequences, construct expression vectors, and verify small-scale expression |
3–4 weeks |
| Recombinant Antibody Expression |
Transient transfection of HEK293 suspension cells to produce 500 mL supernatant, purify >2 mg antibody |
2–3 weeks |
Protheragen's services are built on a foundation of innovation, leveraging the latest advancements in biotechnology to deliver cutting-edge solutions. Whether it is the identification of novel targets, the optimization of antibody constructs, or the execution of preclinical studies, Protheragen is committed to driving the development of next-generation antitumor mAbs that can transform cancer therapeutics. If you are interested in our services, please feel free to contact us.
Reference
- Tsao, Li-Chung, Jeremy Force, and Zachary C. Hartman. "Mechanisms of therapeutic antitumor monoclonal antibodies." Cancer research 81.18 (2021): 4641-4651.
All of our services and products are intended for preclinical research use only and cannot be used to diagnose, treat or manage patients.
