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 This immunomodulatory action led to its initial approval for moderate-to-severe plaque psoriasis before being withdrawn due to safety concerns.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:
  • Hydrogen-deuterium exchange mass spectrometry for conformational epitope fidelity
  • Glycan occupancy profiling at each N-linked site

Mechanistic Validation:

  • CD11a binding kinetics with T-cell avidity testing
  • IL-2 suppression assays in activated PBMCs
2 Next-Gen Cell Line Engineering Hyper-Glycosylation Control:
  • CRISPR-mediated FUT8 knockout for reduced fucosylation
  • GS-CHO platform with tunable MnCl₂ supplementation

Intensified Upstream Process:

  • N-1 perfusion seed train coupled with high-density fed-batch
  • Real-time glucose/galactose monitoring via Raman probes
3 Novel Downstream Paradigms Alternative Capture Technology:
  • Camelid VHH-based affinity ligands replacing Protein A
  • Mixed-mode polishing with ceramic hydroxyapatite

Viral Safety Innovation:

  • UV-C irradiation + anion exchange membrane chromatography
Non-Clinical Development
4 Mechanism-Focused In Vitro Profiling Target Engagement Precision:
  • Single-molecule imaging of CD11a/LFA-1 binding dynamics
  • T-cell synapse formation assays using super-resolution microscopy

Functional Potency:

  • Ex vivo inhibition of mixed lymphocyte reactions
  • Cytokine modulation
5 Predictive In Vivo Models Humanized Mouse Efficacy:
  • Xenograft psoriasis model with patient-derived skin biopsies
  • Quantitative lymphocyte migration tracking via intravital imaging

Safety Pharmacology:

  • CNS penetration studies
  • Reproductive toxicity waiver justification via placental transfer assays
  • 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
  • High-purity biosimilar candidate production
  • Comprehensive structural & functional characterization
  • Target binding kinetics and immunomodulatory activity validation
2 Cell Line Development Services
  • High-expression CHO cell line engineering
  • Clonal selection with productivity >3g/L
  • Cell bank generation & characterization
3 Analytical & Development Data Packages
  • Comparative analytical similarity reports
  • Process development datasets
  • Stability study results
Non-Clinical Data
  • In Vitro Studies
  • In Vivo Studies
  • 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.


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

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