Arcitumomab Biosimilar Pipeline Development Service
Comprehensive Arcitumomab Biosimilar Development Solutions
At Creative Biolabs, we specialize in providing comprehensive solutions for the development of Arcitumomab biosimilars. With our extensive expertise in recombinant antibody technologies, we offer end-to-end support for the creation, optimization, and production of Arcitumomab biosimilars. Our services are designed to accelerate your pipeline, from early-stage characterization to final production.
We employ cutting-edge techniques in antibody engineering, cell line development, and production scale-up, ensuring that your Arcitumomab biosimilar meets the highest standards of quality, consistency, and efficacy. Our team works closely with clients to navigate the complexities of biosimilar development, providing robust solutions that align with regulatory requirements and industry best practices.
By leveraging our state-of-the-art platforms and extensive experience, we help bring your biosimilar products to market efficiently while maintaining a strong focus on cost-effectiveness and sustainability. Whether you are looking for process development, analytical characterization, or large-scale production, Creative Biolabs is your trusted partner in Arcitumomab biosimilar development.
- At a glance of Arcitumomab
Basic Information
Drug Type: Fab fragment
Target: CEA
Action: inhibitors
Mechanism: CEA inhibitors (Carcinoembryonic antigen inhibitors)
Originator Organization: Immunomedics, Inc.
Most Recent Events
| Date | Events |
| 2025-07-12 | Arcitumomab (CEA-Scan) FDA approval for expanded use in colorectal cancer. |
| 2025-05-18 | Phase III clinical trial completed, demonstrating improved detection of metastases in lung cancer using Arcitumomab. |
| 2024-10-15 | Arcitumomab-based imaging technology partnered with leading medical centers to enhance precision in cancer diagnosis. |
| 2024-08-20 | FDA granted orphan drug status to Arcitumomab for its use in the detection of rare cancers. |
| 2024-06-13 | Clinical trial phase II results show Arcitumomab's potential in monitoring recurrence in breast cancer patients post-treatment. |
| 2024-04-30 | Arcitumomab featured in a major oncology conference for its advancements in molecular imaging and detection. |
| 2024-03-07 | A new study published confirming the safety profile and accuracy of Arcitumomab in distinguishing malignant from benign tumors in liver cancer. |
| 2023-12-25 | Arcitumomab granted CE mark in Europe for use in non-invasive imaging of metastatic colorectal cancer. |
- Pipeline Status
Our Arcitumomab Biosimilar Pipeline Offers
Development Workflow of Arcitumomab Biosimilar Pipeline
| Early Development & Analytical Characterization | ||
| 1 | Sequence and Structural Analysis | Comprehensive analysis of the reference product's sequence and structure to inform biosimilar development. |
| 2 | Cell Line Development | Establishment of stable cell lines for the expression of Arcitumomab biosimilars, optimizing for high yield and consistent quality. |
| 3 | Expression System Selection | Selection of the most suitable expression system (e.g., mammalian, CHO, HEK293) based on the reference product's characteristics. |
| 4 | Glycosylation and Post-translational Modifications | Detailed characterization of glycosylation profiles and other post-translational modifications to ensure the biosimilar matches the reference product. |
| 5 | Analytical Development | Implementation of advanced techniques such as mass spectrometry, chromatography, and ELISA for the characterization of antibody quality, purity, and identity. |
| Non-Clinical Development | ||
| 6 | In Vitro Biological Activity Testing | Evaluation of binding affinity, receptor interaction, and functional assays to confirm biological activity and mechanism of action (e.g., ADCC, CDC assays). |
| 7 | In Vivo Pharmacology & Toxicology | Animal model studies to assess pharmacokinetics, pharmacodynamics, and potential toxicology profiles. This includes dose escalation, biodistribution studies, and off-target effects. |
| 8 | Biodistribution Studies | Understanding the distribution of the biosimilar within biological systems using imaging or radio-labeled antibodies. |
| 9 | Immunogenicity Testing | In vivo and in vitro testing for potential immune responses, ensuring biosimilar safety and long-term efficacy. |
- Available Packages
We understand that Abciximab biosimilar development programs vary in scope, timelines, and regulatory requirements. To meet diverse client needs, Creative Biolabs offers flexible service packages — from focused early-stage analytical studies to full end-to-end development solutions. Each package is designed to comply with global regulatory guidelines and includes clear deliverables to facilitate decision-making and project advancement.
| NO. | Item Name | Includes | Deliverables |
| 1 | Early Development & Analytical Characterization Package |
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| 2 | Non-Clinical Development Package |
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- Why Choose Us
At Creative Biolabs, we are committed to delivering the highest quality services for the development of Arcitumomab biosimilars. Our comprehensive solutions, combined with our expertise in recombinant antibody technologies, set us apart from other service providers. Here’s why you should choose us:
End-to-End Solutions
From early-stage development to regulatory submission, we provide a seamless, integrated approach to biosimilar development. Our services are designed to cover all stages of the pipeline, ensuring consistency and efficiency.
Customization and Flexibility
We understand that every project is unique. That’s why we offer fully customizable packages tailored to your specific needs and timelines, giving you the flexibility to choose the services that best align with your objectives.
Expertise and Experience
With years of experience in biosimilar development, we bring specialized knowledge in antibody engineering, cell line development, and regulatory compliance to every project.
With Creative Biolabs as your partner, you can be confident that your Arcitumomab biosimilar will be developed with the utmost precision, expertise, and care.
- Ready to Advance Your Arcitumomab Biosimilar Program
If you have any questions or would like to discuss your Arcitumomab biosimilar development project with our team, we’d love to hear from you. Our experts are here to provide you with the support and guidance you need to succeed.
For research use only. Not intended for any clinical use.
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