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BLA white paper
Literature - Publication Review

Advanced immunoassay technologies for streamlined CMC development of biologics

Accelerate your biologic drug development timeline and strengthen your regulatory submissions with Revvity's proven immunoassay platforms. This comprehensive white paper explores how HTRF®, AlphaLISA®, DELFIA®, and Tag-lite® technologies deliver superior performance for Chemistry, Manufacturing, and Controls (CMC) characterization—helping you meet stringent BLA and MAA requirements with confidence.

In this white paper, you'll discover:

  • Validated approaches for critical quality attribute (CQA) testing, including potency, purity, and receptor binding assays that comply with ICH Q2 R2 standards
  • Real-world case studies demonstrating successful regulatory submissions using Revvity platforms
  • Technical comparisons across HTRF™, AlphaLISA™, DELFIA™, and Tag-lite™ to help you select the optimal platform for your specific application

Whether you're developing monoclonal antibodies, bispecific therapeutics, or other complex biologics, this resource provides actionable insights to streamline your CMC processes and support successful regulatory outcomes.

For research use only. Not for use in diagnostic procedures.

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Advanced immunoassay technologies for streamlined CMC development of biologics

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