Experience.
Analysis.
Analytical Services by a Trusted US-Based CDMO
As a leading US-based CDMO, GBI offers expert analytical services to support the full lifecycle of biologics, from product process development through cGMP manufacturing. With deep experience and expertise in complex modalities—including bio-conjugates such as radioimmune conjugates (theranostic agents), antibody-oligonucleotide conjugates, vaccine conjugates and antibody fusion proteins—GBI is a go-to partner among top-tier CDMO companies in the US.
Our services follow current USP and EP guidance and are applicable to monoclonal antibodies, multi-specifics, vaccines, and other biologics produced through advanced cell culture process development and downstream processing.
Contact UsWhy Analytical Tech Transfer & Assay Verification Matter
Analytical methods are essential for ensuring biologic drug candidates’ safety, identity, purity, and potency. During drug product development, assays are required to:
- Measure drug concentrations (pharmacokinetics) in clinical samples
- Detect neutralizing antibodies and immunogenicity risks
- Characterize drug identity and confirm quality during cGMP manufacturing
Assay verification is the critical first step—confirming that an analytical method (developed in-house or transferred externally) can be reliably performed at GBI on a cGMP scale.
GBI’s Analytical Testing Capabilities
Our protein characterization services include full method development, verification of cell-based and analytical assays. Our Quality Control services include qualification, validation, release testing, stability studies per ICH guidelines.
We support a range of therapeutic modalities and complex formulations.
Our capabilities include:
Chromatography & Electrophoresis
- HPLC: Reverse Phase, Size Exclusion, Ion Exchange, HIC, HILIC
- Capillary Electrophoresis: CE-SDS (R/NR), icIEF
- Gel Electrophoresis: SDS-PAGE (R/NR), IEF
- Protein A HPLC (titer determination)
Immunoassays & Biochemical Methods
- ELISA (potency, host cell protein, residuals, immunogenicity)
- Western Blot
- UV/Vis, colorimetric, fluorescent, and luminescent protein concentration assays
- Fluorescence Spectrometry
- BCA – total protein
Bioconjugation & Binding Analysis
- Protein-to-chelator mole ratio, dye, ligand, peptide or other payload ratio assessment
- ELISA binding
- BCA
Cell-Based Assays & Raw Material Testing (Phase appropriate)
- Potency assays for monoclonal and polyclonal antibodies
- USP/EP raw material testing
- Pharmacopeial testing: pH, osmolality, conductivity, appearance, A280nm, bioburden
Stability & Method Transfer Services
- In-process intermediate hold stability
- Freeze-thaw and forced degradation studies
- Buffer/formulation stability
- Stability via ICH guidelines
- Full method transfer, development, and troubleshooting
We also support assay control strategy design, specification setting, and resolution of assay-related issues throughout clinical and commercial development.
Integrated Analytical Support Across the CDMO Workflow
As a full-service CDMO US biopharma companies rely on, GBI integrates analytical method development with upstream and downstream process development, formulation, bio-conjugation, aseptic fill finish, and stability testing. This holistic approach ensures seamless data continuity, regulatory compliance, and product quality at every phase.
Supporting Analytical Needs for Theranostic, Bioconjugates and other Biologic Therapies
Our analytical team has significant experience supporting theranostic and other bio-conjugates product characterization and regulatory submissions, including radiolabeled antibodies, bio-conjugates and complex fusion proteins requiring multi-parameter assay development and validation.
Partner with a Top CDMO for Analytical Method Development
Whether you need assay development for IND-enabling studies or validated methods for late-stage cGMP manufacturing, GBI offers the technical strength, regulatory insight, and flexible approach to accelerate your drug product development.
Contact us today to learn how our analytical services can streamline your path to clinic or commercialization.
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