Biosimilar

Muromonab Biosimilar Pipeline Development Service

Comprehensive Solutions for CD3-Targeted Biosimilar Development

Creative Biolabs offers full-spectrum Muromonab biosimilar development services, supporting clients from early analytical characterization to regulatory submission. With deep expertise in antibody engineering and CD3-targeted platforms, Creative Biolabs helps you efficiently navigate the biosimilar pipeline with scientific precision and regulatory readiness.

At a glance of Muromonab

Service Overview

Muromonab (OKT3), a murine monoclonal antibody targeting CD3, was historically used for the treatment of acute transplant rejection. Although its clinical use has been discontinued in many regions, Muromonab remains a valuable scaffold for biosimilar development, immunology research, and next-generation antibody platforms such as bispecific antibodies or CAR-T constructs.

Our biosimilar service platform delivers comprehensive support throughout the Muromonab biosimilar development pipeline — from clone generation and bioanalytical profiling to IND-enabling studies and regulatory documentation.

Basic Information

Drug Type: Monoclonal antibody

Synonyms: Anti-CD3 monoclonal antibody OKT3; Monoclonal antibody OKT3; Muromonab CD3

Target: CD3

Action: inhibitors; inducers

Mechanism: CD3 inhibitors (T cell surface glycoprotein CD3 inhibitors); T cell apoptosis inducers

Inactive Indication: Allograft Rejection; Hepatitis C, Chronic; Neoplasms

Originator Organization: Janssen Global Services LLC

Inactive Organization: Ortho Biotech Products LP; Ortho Pharmaceutical Corp; InSpira Medical AB

First Approval Date: United States (19 Jun 1986)

Most Recent Events

Date	Events
Early 2025	Regulatory emphasis on analytical comparability over clinical studies
2025	Proposed U.S. law to streamline biosimilar approvals

Pipeline Status

Our Muromonab Biosimilar Pipeline Offers

Fig.1 Muromonab Biosimilar Pipeline. (Creative Biolabs Original)

Development Workflow of Muromonab Biosimilar Pipeline

Early Development & Analytical Characterization
1	Sequence Retrieval & Bioinformatics Analysis	Utilize publicly available data or originator sequence sources to reconstruct the variable and constant regions of Muromonab. In silico tools are employed to assess sequence liabilities and developability.
2	Cell Line Development	Stable expression in CHO or HEK293 cells is established using optimized vectors. High-producing clones are selected based on yield and quality.
3	Analytical Characterization	Perform comprehensive physicochemical and functional assays, including: Mass spectrometry (MS) for identity and glycan profiling Capillary electrophoresis (CE-SDS) and size exclusion chromatography (SEC) ELISA, SPR, and flow cytometry for binding affinity to CD3
Non-Clinical Development
4	In Vitro Biological Activity Testing	Evaluate T-cell activation, cytokine release, and apoptosis induction to verify bioequivalence with the reference Muromonab.
5	In Vivo Pharmacology & Toxicology	Use relevant animal models (e.g., humanized mice) to assess pharmacokinetics (PK), immunogenicity, and safety profiles. Non-GLP studies guide early formulation and dosage development.

Available Packages

Creative Biolabs offers flexible and modular service packages to meet your Muromonab biosimilar development needs—whether you're just beginning comparability analysis or preparing a full regulatory dossier. Choose the package that best matches your development stage or request a customized solution.

NO.	Item Name	Includes	Deliverables
1	For early-stage development and comparability studies	Recombinant expression of Muromonab biosimilar Purity, identity, and aggregation analysis (HPLC, CE-SDS, SEC) CD3 binding assays (ELISA, SPR, flow cytometry) Glycan profiling & charge variant analysis Stability and forced degradation testing	Detailed analytical comparability report, raw data, CoA
2	For preclinical proof-of-concept and IND-enabling studies	In vitro bioactivity assessment (T-cell activation, cytokine release) Animal PK/PD and immunogenicity studies GLP-compliant toxicology study design and execution Formulation screening and dosage prediction	Study protocols, final study reports, safety summaries
3	Full-Service End-to-End Package	Everything in Packages 1, 2 Stable cell line generation & process development Long-term collaboration for lifecycle	Full data package, IND-ready biosimilar asset, regulatory dossier, and lifecycle plan

Why Choose Us

Muromonab biosimilar development is entering a transformative phase—driven by advances in antibody engineering, streamlined regulatory pathways, and growing demand for accessible CD3-targeted immunotherapies. Creative Biolabs is uniquely positioned to help you accelerate success in this niche yet promising space.

Seize this Opportunity to:

Repurpose a proven scaffold for next-gen immune therapies
Accelerate your biosimilar program with a ready-to-launch platform
Navigate global biosimilar pathways with confidence
Access high-purity RUO-grade Muromonab biosimilars
Partner with a true CD3 antibody specialist

Case Experience Snapshot

Successfully delivered an analytical comparability study for a Muromonab-like biosimilar candidate within 6 months, including bioassay validation and full physicochemical profiling.
Supporting multiple biosimilar programs targeting CD3, CD19, PD-1, and HER2 with seamless transitions from early development to IND submission.

Who We Support

Biopharmaceutical companies developing biosimilars for transplant or immune-modulating indications
CDMO partners seeking Muromonab intermediates for bispecific or CAR-T construct use
Academic and translational institutions focused on CD3-mediated immunotherapies

Ready to Advance Your Muromonab Biosimilar Program

Let us help you design a customized development plan tailored to your regulatory goals and project timelines.

For research use only. Not intended for any clinical use.

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