Biologics Analytical Services
PATIENT-READY BIOLOGICS START WITH ANALYTICAL CLARITY
From pre-IND through commercial release, our scientists bring the deep expertise and infrastructure to keep your biologic on the path to patients.
- 200+ Scientists dedicated to large molecule analytics
- 800+ Assays and techniques across modalities
- 31K+ ft² stability storage capacity
- 300+ Client programs supported to date
EXPERTISE YOU WON’T FIND ON A RESUME
Our leadership team averages 20+ years in large molecule analytical services. With 30+ years of collective experience spanning pre-IND through NDA, BLA, MAA, and commercial release, we’ve seen what regulators expect before they ask for it.
TAILORED, NOT TEMPLATED
Every biologic has its own analytical fingerprint. We pair routine release and stability testing with specialized orthogonal approaches and complex troubleshooting, all under one roof. No handoffs. No gaps.
SCALE THAT MATCHES YOUR AMBITION
From a single release test to a full analytical transfer, our infrastructure is built for biologics at every stage. We don’t just support your program. We scale with it.
- 20+ Average years of leadership experience in large molecule analytical services.
- 30+ Years of regulatory experience from pre-IND through commercial release.
- 100% Full release and stability support under one roof, no outsourced handoffs.
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PHASE-APPROPRIATE, REGULATORY-READY ANALYTICS
Delivered from our Kansas City Center of Excellence, supporting biologics from discovery through commercial release.
- Developability & Early Risk Assessment
- Formulation & Pre-Formulation Development
- Analytical Method Development & Validation
- Structural, Molecular & Variant Characterization
- Mass Spectrometry-Enabled CQA & Comparability
- Impurity & Degradation Analysis
- Potency, Bioassays & Functional Characterization
- Stability Programs & Sample Management
- Regulatory, Lifecycle, GMP Readiness Support
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BUILT FOR THE BREADTH OF MODERN BIOLOGICS
- Monoclonal Antibodies
- Bispecific & Multispecific Antibodies
- Antibody Fragments
- Antibody-Drug Conjugates
- Bioconjugates
- Fusion Proteins
- Enzymes
- Recombinant Proteins
- Peptides
- Nucleic Acids
- Cell & Gene Therapy