Biosimilar Development & Testing Services
Transform your biologics development journey with comprehensive biosimilar testing support. Accelerate your path to market through precise analytical characterization, streamlined regulatory documentation, and expert guidance. Deliver safe, effective, and affordable therapies while maintaining the highest quality standards throughout your development process.
What is Biosimilar Development & Testing Services at Element?
Biosimilar development requires precise analytical characterization to demonstrate high similarity to reference biologics while meeting strict regulatory requirements. At Element, we provide comprehensive testing services throughout your development journey, from initial characterization through regulatory submission. Our services encompass structural analysis, bioactivity testing, stability studies, and complete regulatory documentation support.
What Can Element Offer You For Biosimilar Development & Testing Services?
Materials and products we test
Materials and products we test
Our comprehensive testing capabilities cover the full spectrum of biologics analysis, from reference products to biosimilar candidates. We specialize in complex molecular characterization, structural analysis, and functional testing of biological products throughout their development lifecycle.
Specialized testing includes:
- Reference biologics and biosimilar candidates
- Interchangeable biological products
- Cell-based bioassays
- Protein therapeutics
Key tests offered
Key tests offered
We deliver detailed molecular identification, amino acid sequence analysis, and comprehensive purity assessments. Our services include bioactivity and potency assays, receptor binding studies, and extensive stability testing to support your development goals and regulatory requirements.
Core testing capabilities:
- Molecular identification and sequence analysis
- Purity assessments and impurity identification
- Bioactivity and potency assays
- Receptor binding studies
- Stability testing and forced degradation studies
Methods and solutions offered
Methods and solutions offered
Our approach combines critical quality attribute determination, expression system optimization, and thorough manufacturing process review. Element helps select and build biosimilarity methods based on the nature of your reference product, its heterogeneity, and structure. We provide complete 351(k) application support and interchangeable biological product testing, backed by extensive regulatory expertise.
Comprehensive solutions include:
- Critical quality attribute (CQA) determination
- Expression system review and selection
- Manufacturing process review
- 351(k) application support
- Interchangeable biological product testing
Which labs offer this service
Which labs offer this service
Our team operates from Life Sciences hubs across the world, providing global access to our expert capabilities. Find your nearest Life Sciences hub on our Locations Page.
Industry-leading expertise and support
Industry-leading expertise and support
Our team provides comprehensive guidance through the FDA 351(k) pathway, helping you navigate complex requirements while maintaining compliance and accelerating your development timeline.
Element’s biosimilar services are designed to support the success of your biosimilar development. With extensive expertise in biologic analysis and reverse engineering, our team has the skills and tools to accelerate your program. We specialize in the 351(k) application and approval pathway, which requires detailed analytical characterization of both the reference biologic and proposed biosimilar to demonstrate structural and functional similarity. Our services ensure that your biosimilar meets FDA standards for safety, purity, and potency.
We provide a comprehensive suite of biosimilar testing services built on quality and efficiency, offering fast turnaround times and robust data. Our regulatory experts offer guidance on the data and documentation needed for 351(k) applications and can help determine if an interchangeable product designation is appropriate. Partner with Element to leverage our biologic analysis, reverse engineering, and regulatory expertise to accelerate your biosimilar program.
Standards we test to and materials we test
- FDA 351(k) regulatory requirements
- FDA interchangeable biological product requirements
- Reference biologics
- Biosimilar candidates
- Interchangeable biological products
- Cell cultures
- Protein therapeutics
- Receptor binding molecules
- Cell-based bioassays
Your Challenges, Our Solutions
Reverse engineering complex molecules
Defining quality attributes
Understanding path to regulatory success
Maximizing development efficiency
Why Choose Element
Global expertise network
Industry-leading experience
Regulatory excellence
Complete solution provider
Explore our global network of labs and find your nearest location
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