Biologics Analytical Capabilities
Integrated, phase-appropriate biologics analytical development and GMP testing, accelerating timelines and delivering audit-ready methods from development through commercial release.
Full in-house and integrated execution
All capabilities under one roof, enabling accelerated timelines and complete delivery
Smart analytical strategies
Right-sizing assay strategies around CQAs and MoA for faster decisions
Phase-appropriate testing
Avoiding over-testing and regulatory risks
“Every assay we design supports CQAs and faster decisions with regulator-ready data. We never compromise on quality.”
When silos create setbacks
- Over- or under-testing driving costs and risks
- Errors during method validation
- Misaligned analytics leading to delays
Analytics built for impact
- Assay plans aligned with MoA and CQAs
- Phase-appropriate depth for speed and rigor
- Built for future submissions and tech transfer
- Integrated with Process Development and Quality Assurance to avoid surprises
CQA-driven, submission-ready, integrated with GMP
From concept to commercialization, our analytics provide the speed, insights, and control you need to accelerate your biologics programs with confidence
Integrated analytics, accelerated decisions
Analytics, process development, MSAT, and quality teams work in sync to deliver real-time support. Centralized data systems ensure visibility and speed, resulting in faster cycle times, tighter control, and submission-ready packages without rework.
Fit-for-purpose analytical strategies
CQA-driven assay strategies aligned with MoA and regulatory expectations deliver only the data that matters. This focused, phase-appropriate approach accelerates decisions, reduces costs, improves confidence, and prevents regulatory gaps.
Integrated teams
Integrated teams manage method development, qualification, and validation through to tech transfer. Harmonized methods across sites ensure seamless scale-up, faster timelines, lower costs, and consistent, inspection-ready data.
Method development, GMP validation, stability, and potency testing for biologics
Our biologics analytical services generate decision-enabling, submission-ready data, harmonized across clinical and commercial sites, and fully integrated with process development, MSAT, and QA.
Analytical services
Services that speed progress and reduce risk
- Method development, qualification & validation
- Tech transfer & method bridging
- Characterization: identity, purity, structure, variants
- Potency testing: ELISA, SPR/BLI, cell-based
- Stability studies: ICH, accelerated, forced degradation
- In-use compatibility studies
- Release testing: sterility, endotoxin, bioburden, mycoplasma
- Raw material, IPC & excipient testing
- CMC filing support for analytical sections
Key Technologies
Technologies that drive quality and efficiency
- Chromatography systems: affinity, CEX, RP-UPLC, HILIC, SEC
- Electrophoresis and peptide mapping (LC-MS)
- HPLC-CAD and UV systems (UV, UV SOLO)
- Bioassay platforms: ELISA, SPR, BLI
- qPCR and molecular testing
- Endotoxin, bioburden, and sterility testing
- pH, osmolality, and turbidity measurement
Where dedication
delivers capabilities
End-to-end European biologics CDMO services deliver drug substance and drug product solutions, including “ready to fill” products at lower cost, and with greater efficiency.
Process development & characterization
Scalable upstream and downstream processes built for robustness
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GMP manufacturing
Flexible capacity and inspection-ready operations for biologics production
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Quality
Systems aligned with regulatory requirements, confirmed by successful inspections and focused on lifecycle aspects
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Why biotechs and
biopharmaceuticals
choose Rezon Bio
We combine the scale of an established European CDMO with the agility of a focused partner, backed by proven end-to-end biologics expertise across development and GMP manufacturing.
Transparent. Clear. Reliable.
Partner with a European biologics CDMO dedicated to deliver program success
- Whether you’re advancing a novel biologic or planning for commercial scale, Rezon Bio is ready to help you move forward with confidence
- Connect with our team to explore how our expertise, integrated solutions, and dedication can accelerate your success