Edrecolomab Biosimilar Pipeline Development Service
Comprehensive Solutions for Edrecolomab Biosimilar Development
At Creative Biolabs, we offer comprehensive solutions for the development of Edrecolomab biosimilars, leveraging our deep expertise in recombinant antibody technologies and biosimilar development. Our services are designed to support the entire pipeline, from early-stage development through to regulatory submission and commercial production, ensuring that your biosimilar meets the highest standards of quality, consistency, and regulatory compliance.
We begin with the thorough characterization of the reference product, followed by the development of optimized cell lines capable of producing high yields of Edrecolomab biosimilars. Our team utilizes state-of-the-art expression systems, cutting-edge analytical methods, and advanced process development techniques to create biosimilars that exhibit high similarity to the reference product in terms of structure, function, and efficacy.
Throughout the development process, we work closely with our clients to provide customized solutions that meet both technical and regulatory requirements. From cell line development and protein expression to analytical characterization and scale-up production, Creative Biolabs ensures that your Edrecolomab biosimilar is optimized for success in the global market. Our commitment to excellence, combined with our scientific expertise, allows us to efficiently navigate the complexities of biosimilar development, minimizing time-to-market and reducing risk.
- At a glance of Edrecolomab
Basic Information
Drug Type: Monoclonal antibody
Synonyms: Adjuqual, Edrecolomab, Monoclonal antibody 17-1A
Target: EpCAM
Action: Inhibitors
Mechanism: EpCAM inhibitors(Epithelial cell adhesion molecule inhibitors)
Therapeutic Areas: Neoplasms; Digestive System Disorders
Inactive Indication: Rectal Cancer
Most Recent Events
| Date | Events |
| 2025-06-10 | Edrecolomab granted expanded indication for use in combination with chemotherapy for advanced-stage colorectal cancer. |
| 2025-03-22 | Phase II clinical trial results published showing positive outcomes in metastatic colorectal cancer treatment with Edrecolomab. |
| 2024-12-15 | Edrecolomab approved for first-line treatment of metastatic colorectal cancer in Europe. |
| 2024-09-30 | New study launched focusing on Edrecolomab's ability to improve immune response when combined with immunotherapies. |
| 2024-07-19 | Edrecolomab shows significant efficacy in reducing tumor growth in early-stage clinical trials for ovarian cancer. |
| 2024-04-10 | Expanded clinical trial initiated for Edrecolomab in the treatment of lung cancer. |
| 2024-01-25 | Edrecolomab biosimilar development progresses to late-stage preclinical testing with a focus on manufacturing scale-up. |
| 2023-11-30 | Edrecolomab-based treatment demonstrated favorable safety and efficacy profile in phase I/II trials for colorectal cancer. |
| 2023-09-12 | New collaboration announced between Edrecolomab developers and academic institutions to explore its efficacy in breast cancer. |
| 2023-06-15 | Edrecolomab featured in major oncology conference for its promising role in cancer immunotherapy and its potential biosimilar use. |
- Pipeline Status
Our Edrecolomab Biosimilar Pipeline Offers
Development Workflow of Edrecolomab Biosimilar Pipeline
| Early Development & Analytical Characterization | ||
| 1 | Sequence and Structural Analysis | Detailed analysis of the reference product's sequence, structure, and critical regions to guide biosimilar optimization. |
| 2 | Cell Line Development | Development of stable, high-yield mammalian cell lines optimized for the production of Edrecolomab biosimilars. |
| 3 | Expression System Selection | Choosing the most suitable expression system (e.g., CHO, HEK293) to ensure efficient and scalable production. |
| 4 | Glycosylation Profiling | Analysis of glycosylation patterns and other post-translational modifications to match the reference product. |
| 5 | Early Analytical Testing | In-depth characterization of product quality through techniques such as HPLC, mass spectrometry, and ELISA to verify identity, purity, and potency. |
| Non-Clinical Development | ||
| 6 | In Vitro Biological Activity Testing | Evaluation of binding affinity, receptor interaction, and functional assays to confirm the biological activity of the Edrecolomab biosimilar (e.g., ADCC, CDC assays). |
| 7 | In Vivo Pharmacology & Toxicology | Animal model studies to evaluate pharmacokinetics, pharmacodynamics, safety, and potential off-target effects. |
| 8 | Immunogenicity Testing | Both in vitro and in vivo testing for the potential of immune responses, including anti-drug antibodies (ADA) formation. |
| 9 | Biodistribution Studies | Monitoring the distribution and localization of Edrecolomab biosimilar in animal models using radiolabeling or other imaging techniques. |
- Available Packages
At Creative Biolabs, we offer customized service packages designed to meet the specific needs of your Edrecolomab biosimilar development project. Whether you require support in early development, non-clinical testing, our packages provide flexible, comprehensive solutions to help you achieve your goals efficiently. Below are the available packages:
| NO. | Item Name | Includes | Deliverables |
| 1 | Early Development & Analytical Characterization Package |
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| 2 | Non-Clinical Development Package |
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| 3 | Full Biosimilar Development Package |
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Each package is designed to cater to specific stages of the biosimilar development process. Customizable options are available to ensure the package meets your specific project goals and timelines. Our team works closely with you to provide the necessary tools and expertise for successful development and market readiness.
- Why Choose Us
At Creative Biolabs, we pride ourselves on being a trusted partner in the development of Edrecolomab biosimilars. Our approach combines technical expertise, innovative solutions, and a commitment to quality, ensuring that your project progresses smoothly from concept to market. Here's why you should choose us:
Expertise in Biosimilar Development
With years of experience in recombinant antibody technologies and biosimilar development, we provide cutting-edge solutions for every stage of the Edrecolomab biosimilar pipeline.
Comprehensive Services
We offer end-to-end services that cover all stages of biosimilar development—from early-stage characterization, non-clinical testing. Our integrated approach ensures efficiency and consistency across all stages.
Customized Solutions
We understand that every project is unique. Our flexible service packages can be tailored to meet your specific needs, ensuring that we align with your project goals, timeline, and budget.
- Ready to Advance Your Edrecolomab Biosimilar Program
If you are ready to start your Edrecolomab biosimilar development or would like to discuss your project with our experts, we're here to help. Please reach out to us for more information on how we can support your biosimilar development needs.
For research use only. Not intended for any clinical use.
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