Basiliximab Biosimilar Pipeline Development Service

Comprehensive Solutions for Basiliximab Biosimilar Development

At Creative Biolabs, we specialize in providing comprehensive development services for Basiliximab biosimilars. Our expertise in recombinant antibody technologies allows us to deliver high-quality solutions across all stages of the biosimilar pipeline. From early-stage characterization to large-scale production, we ensure your biosimilar meets the highest standards of quality, consistency, and regulatory compliance.

Our services include cell line development, analytical characterization, process optimization, and regulatory support, all designed to streamline the development of your Basiliximab biosimilar. We focus on producing biosimilars that are structurally and functionally comparable to the reference product, ensuring a smooth transition from development to commercialization.

  • At a glance of Basiliximab

Basic Information

Drug Type: Monoclonal antibody

Synonyms: Basiliximab (Genetical Recombination); Basiliximab (genetical recombination) (JAN); Basiliximab (USAN/INN)

Target: IL2RA

Action: inhibitors

Mechanism: IL2RA inhibitors(Interleukin-2 receptor alpha chain inhibitors)

Therapeutic Areas: Immune System Diseases

Active Indication: Renal transplant rejection; Graft Rejection

Inactive Indication: Acute Graft Versus Host Disease; Alpha 1-Antitrypsin Deficiency; Bronchiolitis Obliterans

Originator Organization: Novartis Pharma AG

Most Recent Events

Date Events
2025-06-05 New indication for Basiliximab approved for use in pediatric kidney transplant patients, expanding its therapeutic scope.
2025-03-18 Study results published showing that Basiliximab improves graft survival in high-risk kidney transplant recipients.
2024-12-20 European Medicines Agency (EMA) approval for Basiliximab's use in combination with other immunosuppressants for liver transplant.
2024-10-10 Phase III trial for Basiliximab in renal transplant patients with autoimmune conditions begins enrollment.
2024-08-15 Basiliximab shows positive results in reducing organ rejection rates in heart transplant recipients during clinical trials.
2024-06-22 FDA issues updated guidance on Basiliximab use in transplant procedures, further supporting its role in immunosuppressive regimens.
2024-04-25 Basiliximab biosimilar development progresses to late-stage clinical trials, aimed at reducing transplant rejection rates.
2024-02-14 New pharmacokinetic study of Basiliximab published, demonstrating its long-term stability and efficacy in solid organ transplant.
2023-11-30 Basiliximab clinical trials extend to pediatric patients undergoing liver transplant, demonstrating safety and efficacy.
2023-09-05 New collaboration announced between the manufacturers of Basiliximab and an academic institution to study its effects in autoimmune diseases.
  • Pipeline Status

Our Basiliximab Biosimilar Pipeline Offers

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

Development Workflow of Basiliximab Biosimilar Pipeline

Early Development & Analytical Characterization
1 Sequence Analysis and Structural Characterization Detailed examination of the reference product's sequence, structure, and functional sites to inform biosimilar development.
2 Cell Line Development Generation of stable mammalian cell lines that express Basiliximab biosimilars with high yield and consistency.
3 Expression System Optimization Selection and optimization of the most suitable expression system (e.g., CHO, HEK293) for efficient production of Basiliximab biosimilars.
4 Glycosylation Profiling Analysis of glycosylation patterns to ensure the biosimilar matches the reference product in terms of post-translational modifications.
Non-Clinical Development
5 In Vitro Biological Activity Testing
  • Functional assays (e.g., ADCC, CDC, receptor binding assays) to confirm the biological activity of the Basiliximab biosimilar.
6 In Vivo Pharmacology & Toxicology
  • Animal model studies to assess the pharmacokinetics (PK), pharmacodynamics (PD), and potential toxicology of the biosimilar.
7 Immunogenicity Testing
  • Both in vitro and in vivo assessments to evaluate the potential immune response, including anti-drug antibody (ADA) formation.
  • Available Packages

At Creative Biolabs, we offer a range of service packages tailored to meet the specific needs of your Basiliximab biosimilar development project. These packages cover every stage of the biosimilar pipeline, from early development through to regulatory submission, ensuring a seamless and efficient process. Below are the available packages:

NO. Item Name Includes Deliverables
1 Early Development & Analytical Characterization Package
  • Sequence and structural analysis of the reference product, Cell line development, Expression system optimization, Glycosylation profiling, Analytical testing for purity, identity, and potency
  • Detailed report on sequence analysis, Optimized cell line, Glycosylation and analytical profiles, Characterization results (HPLC, Mass spectrometry)
2 Non-Clinical Development Package
  • In vitro biological activity testing (e.g., ADCC, CDC), In vivo pharmacology studies (PK/PD), Immunogenicity testing, Biodistribution studies, Toxicology assessments
  • In vitro activity reports, In vivo pharmacology results, Immunogenicity and toxicology data summaries, Biodistribution study findings
3 Full Biosimilar Development Package
  • All services from Early Development, Non-Clinical Development, Dedicated project management support
  • Complete development and regulatory packages covering all phases, Full documentation, Ongoing support for regulatory compliance and post-launch monitoring
  • Why Choose Us

At Creative Biolabs, we are committed to providing high-quality, reliable, and efficient services for the development of Basiliximab biosimilars. Here's why we are the preferred partner for your biosimilar development needs:

Expertise in Biosimilar Development

With extensive experience in recombinant antibody technologies and biosimilar development, we provide advanced, scientific solutions across every stage of the pipeline.

Customized Service Packages

We understand that every project is unique. We offer flexible, tailored service packages designed to meet your specific needs and timelines, helping you maximize efficiency and reduce costs.

Proven Track Record

We have successfully supported numerous biosimilar projects, providing expert guidance and comprehensive support to help our clients meet their development goals.

By partnering with Creative Biolabs, you gain access to a team of experts dedicated to ensuring the success of your Basiliximab biosimilar development, from discovery through commercialization.

  • Ready to Advance Your Basiliximab Biosimilar Program

If you are ready to move forward with your Basiliximab biosimilar development or need more information about our services, we're here to help. Please get in touch with us, and our experts will assist you every step of the way.


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