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Monoclonal Antibodies

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Product

Monoclonal Antibodies

Research and pre-clinical grade monoclonal antibodies for target validation, assay development and biosimilar reference work.

01 — Overview

What you are buying

Antibody supply is rarely the hard part — consistency between lots is. Our mAbs are produced under process-controlled conditions and released against defined specifications, so the material you validate a method against is the material you receive six months later.

  • Target validation and screening
  • Biosimilar reference and comparability work
  • Assay development and method qualification
  • Immunoassay and diagnostic development
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Portfolio

Therapeutic antibody programmes.

A growing pipeline of biosimilar and novel therapeutic monoclonal antibodies, developed on Theertha's mammalian expression and purification platforms.

Process development

Trastuzumab

Anti-HER2 therapeutic monoclonal antibody — in process development.

Preclinical

Pembrolizumab · biosimilar

Anti-PD-1 checkpoint inhibitor — preclinical stage.

Clone development

Ustekinumab · biosimilar

Anti-IL-12/23 monoclonal antibody — clone development.

Clone development

Dostarlimab · biosimilar

Recombinant anti-PD-1 antibody — clone development.

Clone ready

Ranibizumab · biosimilar

Anti-VEGF-A antibody fragment — clone ready.

Development stages reflect current technical progress and do not imply regulatory approval or commercial availability. See our full pipeline.

End to end

Concept to commercial.

We support antibody programmes across the full development journey — take one module or the whole chain.

01

Target & clone

Construct design, gene synthesis and mammalian cell-line development, with regulatory-ready documentation from day one.

02

Process development

Upstream and downstream development engineered for high titre and recovery, scaling predictably from bench to pilot.

03

Analytical & characterization

Method development, qualification and validation with orthogonal product characterization.

04

Formulation

Formulation and stability programmes that carry a candidate into pre-clinical and clinical supply.

05

Scale-up & technology transfer

Documentation-first transfer to your site or manufacturer, with comparability and bridging studies.

06

Toward clinical & commercial supply

A clear path toward clinical and commercial supply, supported through our CDMO/CRO capabilities and partners.

Programme detail

Every antibody, in detail.

A closer look at each programme in our monoclonal-antibody portfolio — its target, class and current development stage.

01 — Process development

Trastuzumab

Anti-HER2 monoclonal antibody and the reference molecule for HER2-positive breast and gastric cancer. Theertha has taken Trastuzumab into process development — upstream and downstream unit operations are being optimised for titre, recovery and a comparability-ready quality profile on our mammalian platform.

Enquire about Trastuzumab
THEERTHATrastuzumabAnti-HER2 · IgG1 mAbPROCESS DEVELOPMENTFOR RESEARCH & DEVELOPMENT USE
02 — Preclinical

Pembrolizumab

Anti-PD-1 checkpoint inhibitor and one of the most widely used immuno-oncology antibodies. As a biosimilar candidate it sits at preclinical stage, with cell-line and early process work underway to establish a developable, comparable molecule.

Enquire about Pembrolizumab
THEERTHAPembrolizumabAnti-PD-1 · IgG4 biosimilarPRECLINICALFOR RESEARCH & DEVELOPMENT USE
03 — Clone development

Ustekinumab

Anti-IL-12/23 antibody used across immunology indications including psoriasis and inflammatory bowel disease. The programme is in clone development — expression clones are being generated and screened for productivity and product quality.

Enquire about Ustekinumab
THEERTHAUstekinumabAnti-IL-12/23 · IgG1 biosimilarCLONE DEVELOPMENTFOR RESEARCH & DEVELOPMENT USE
04 — Clone development

Dostarlimab

Recombinant anti-PD-1 antibody. At clone development, Theertha is building the expression system and the early analytical package that will define comparability.

Enquire about Dostarlimab
THEERTHADostarlimabAnti-PD-1 · IgG4 biosimilarCLONE DEVELOPMENTFOR RESEARCH & DEVELOPMENT USE
05 — Clone ready

Ranibizumab

Anti-VEGF-A antibody fragment for ophthalmic indications. The programme is clone ready — a productive clone is established and it is positioned to enter process development.

Enquire about Ranibizumab
THEERTHARanibizumabAnti-VEGF-A · Fab biosimilarCLONE READYFOR RESEARCH & DEVELOPMENT USE

Development stages reflect current technical progress and do not imply regulatory approval or commercial availability. Vial imagery is an illustrative representation of Theertha development material, not finished commercial product.

Enquiry

Need a custom specification?

Most of what we supply is programme-specific. Send us the requirement and we will confirm feasibility, timeline and price.