Analytics & GMP Testing

Analytical strength, regulatory certainty

Analytics is the backbone of every CMC decision. With 160+ analytical methods and 15+ years of GMP experience, we support molecules from early characterization through release-relevant data packages.

Our results are traceable, well-founded, and aligned with international guidelines — enabling partners to move forward with confidence.

GMP Testing & Release

GMP release
you can rely on

From analytical certainty to regulatory approval

GMP release confirms that your product meets regulatory requirements for clinical or commercial use. Our GMP activities extend beyond release testing and include stability studies, comparability assessments, reference material qualification, and audit-ready quality systems.

Our framework combines analytical depth, validated methods, structured documentation, and QA oversight — supporting GMP releases that withstand audits and regulatory review.

What our GMP framework covers:

  • Qualified and validated test methods
  • Specification development support within the CMC framework
  • Batch release testing and documentation
  • QP oversight

What you gain:

  • Reliable timelines
  • Transparent communication
  • Traceable, robust data
  • Clear decisions at every milestone
Our Approach

Scientific depth, regulatory precision

We design analytical strategies around molecule-specific CQAs and apply a Quality-by-Design mindset to method development, qualification, and validation.

Analytical workflows integrate seamlessly with cell line and process development, ensuring that data aligns across all stages and supports informed, audit-ready CMC decisions.

Our approach includes:

  • CQA-driven analytical strategy and risk assessment
  • Method development, qualification, and validation
  • Integration with clone and process development
  • Structured data evaluation and documentation aligned with GMP expectations
Expertise & Technologies

Technologies that create clarity and confidence

Our analytical platform covers the full spectrum of physicochemical, structural, and functional methods — providing a comprehensive molecular fingerprint and a solid foundation for regulatory submissions.

Core capabilities:

  • Identity, purity, charge and size variants
  • Higher-order structure and post-translational modifications
  • Potency and binding assays (ELISA, cell-based)
  • Stability studies (accelerated, real-time, stress)
  • Forced degradation analytics
  • Comparability and biosimilarity assessment
Results & Track Record

Proven performance across programs

Our analytical and GMP testing activities are grounded in reproducible methods, structured documentation, and regulatory-aligned execution. The scope and outcomes of this work are documented in our Track Record.

See full Track Record
Contact

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