Efalizumab Biosimilar Pipeline Development Service
Comprehensive Solutions for CD11a-Targeted Biosimilar Development
Creative Biolabs delivers comprehensive CD11a-targeted biologic development solutions, specializing in Efalizumab biosimilars from discovery through commercialization. Our integrated approach combines advanced antibody engineering capabilities with robust analytical development, enabling clients to accelerate biosimilar programs while maintaining strict compliance with global regulatory standards. Leveraging our specialized immunomodulation platform and extensive characterization expertise, we support every development phase - including structural analysis, functional assays, process optimization, and comparability studies - to ensure successful market entry. Our team's deep understanding of T-cell modulation pathways further enhances the development of high-fidelity biosimilars with optimized safety and efficacy profiles.
- At a glance of Efalizumab
Service Overview
Efalizumab is a humanized monoclonal antibody targeting CD11a, a subunit of lymphocyte function-associated antigen-1 (LFA-1) that plays a crucial role in T-cell activation and migration. By binding to CD11a, it modulates immune responses through multiple mechanisms: blocking T-cell adhesion to antigen-presenting cells, inhibiting their trafficking to inflammatory sites, and reducing activation. This immunomodulatory action led to its initial approval for moderate-to-severe plaque psoriasis before being withdrawn due to safety concerns. The antibody's unique mechanism continues to make it a valuable research tool for studying T-cell-mediated autoimmune pathways. Current biosimilar development requires thorough characterization of its complex immunomodulatory effects and careful risk-benefit evaluation, with particular attention to its distinct safety profile compared to other biologics.
Basic Information
Drug Type: Monoclonal antibody
Synonyms: anti-CD11a; antiCD11 alpha; Efalizumab (USAN/INN)
Target: CD11a
Action: Antagonists
Mechanism: CD11a antagonists(Leukocyte adhesion glycoprotein LFA-1 alpha antagonists)
Inactive Indication: Age Related Macular Degeneration; Alopecia totalis; Arthritis, Psoriatic
Originator Organization: Genentech, Inc.
Inactive Organization: Genentech, Inc.; Merck Serono Europe Ltd.; Merck KGaA
First Approval Date: United States (27 Oct 2003)
Most Recent Events
| Date | Events |
| 02 NOV 2023 | Endeavor BioMedicines Appoints Paul Frohna, M.D., Ph.D., as Chief Medical Officer |
| 07 DEC 2022 | Tenaya Therapeutics Appoints Amy Burroughs to Board of Directors |
Development Workflow of Efalizumab Biosimilar Pipeline
| Early Development & Analytical Characterization | ||
| 1 | Deep-Dive Reference Product Deconstruction |
Extended Structural Mapping:
Mechanistic Validation:
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| 2 | Next-Gen Cell Line Engineering |
Hyper-Glycosylation Control:
Intensified Upstream Process:
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| 3 | Novel Downstream Paradigms |
Alternative Capture Technology:
Viral Safety Innovation:
|
| Non-Clinical Development | ||
| 4 | Mechanism-Focused In Vitro Profiling |
Target Engagement Precision:
Functional Potency:
|
| 5 | Predictive In Vivo Models |
Humanized Mouse Efficacy:
Safety Pharmacology:
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- Available Packages
Creative Biolabs provides flexible, modular service bundles to address your Efalizumab biosimilar development needs—whether you're in the early phases of comparability analysis or preparing a full regulatory dossier. Select the bundle that aligns with your development stage, or ask for a tailored solution.
| Items | classification | What we can offer |
| 1 | Antibody-Specific Solutions |
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| 2 | Cell Line Development Services |
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| 3 | Analytical & Development Data Packages |
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- Why Choose Us
Unparalleled Technical Expertise in Immune Modulation
Deep Target Knowledge: Specialized in CD11a/LFA-1 pathway characterization with proprietary T-cell activation assays
Advanced Analytics: Cryo-EM structural analysis cytokine profiling for unprecedented characterization depth
Innovative Formulation: Proprietary stabilization technology for this sensitive fusion protein
Risk-Reduced Development Pathway
Platform Process for T-Cell Modulators: Pre-optimized expression system specifically for immunomodulatory biologics
Safety-Focused Approach: Built-in PML risk assessment protocols from first development stage
Regulatory-Smart Strategy: Pre-submission gap analysis aligned with latest EMA biosimilar guidelines
Time and Cost Efficiencies
Accelerated Timelines: 30% faster clone screening using microfluidics-based selection
Cost-Effective Solutions: Shared development models for reduced capital expenditure
Flexible Engagement: From standalone analytical services to full program management
- Ready to Advance Your Efalizumab Biosimilar Program
We're ready to collaborate with you on a personalized development strategy aligned with your specific regulatory objectives and project schedule. Contact us now to receive a quote, arrange a one-on-one consultation, or access our detailed service brochure.
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