Analytical Services
for Biologics
Standalone and Integrated Analytical Services
From Early Development Through Commercial Manufacturing
Whether you need standalone analytical services or analytical support integrated with your biologics program, our experienced scientists work alongside your team to develop customized, phase-appropriate strategies that support quality, regulatory readiness, and product success. From analytical method development and protein characterization to GMP quality control testing, potency assays, and stability studies, we help define and measure the critical quality attributes (CQAs) that matter most throughout your product lifecycle.
Move Your Molecule Forward
Preclinical
Early Phase
Late Phase
Commercial
Analytical Expertise Built Around Your Program
Every biologic presents unique analytical challenges. Cytovance develops customized analytical strategies that align with your molecule, development stage, and regulatory goals. Whether supporting early development, technology transfer, clinical or commercial GMP manufacturing, our analytical services are designed to evolve with your program and to help you prepare for filing (IND and BLA) and commercial manufacturing.
Non-GMP Analytical Services
• Analytical method development
• Analytical method transfer
• Feasibility studies
• Method qualification
• Stability studies
• Forced degradation studies
• Comparability studies
• Outsourced analytical testing management
GMP Analytical Services
• Method transfer
• Method validation
• Material storage
• API stability studies
• Drug product stability studies
• Comparability studies
• Reference standard characterization
• Quality Control analytical testing
• Outsourced testing management
Introducing the Cytovance Analytical Testing Portal
Streamlined, customized analytical testing services have never been easier to access. Leverage our one-stop-shop portal for service ordering, sample submission, and progress tracking. There is no need to be a current manufacturing customer; our experienced team is ready to provide analytical support for your program today.
Protein Characterization For Deeper Product Understanding
Successful biologics development depends on understanding your molecule at every stage. Cytovance performs comprehensive protein characterization to evaluate identity, purity, aggregation, charge variants, and other CQAs that support process development, comparability, and regulatory submissions.
Methods to Assess Your Product
Physical Characteristics:
- Appearance
- Conductivity
- Osmolality
- pH
Product Safety (Residual Testing - Process Related Impurities):
- Bioburden
- DNA by Quantitative PCR
- Endotoxin
- Host Cell Proteins (CHO and E. coli)
- IPTG
- Kanamycin
- ProteinA (select resins)
Product Content/Titer:
- Absorbance at 280 nm (cuvette and variable path length spectroscopy)
- Biolayer interferometry (OCTET-BLI)
- Colorimetric methods (BCA, Bradford, and Lowry)
- ELISA
- HPLC
Product Purity and Heterogeneity:
- Capillary methods (cGE and cIEF)
- HPLC/UPLC (HILIC, IEX, SEC, and RP)
- SDS-PAGE
Product Identity:
- Biolayer interferometry (OCTET-BLI)
- ELISA
- Peptide Map (HPLC/UPLC-UV)
- SDS-PAGE
- Western Blot
Product Efficacy:
- Biolayer interferometry (OCTET-BLI)
- Cell-based bioassays
- ELISA
Characterization Assays:
- Aggregation/size distribution by DLS or SEC-MALS
- MS/MS High Resolution Mass Spectrometry
- Disulfide Bond Analysis
- Glycan analysis
- Intact mass
- Peptide mapping
- Post translational modifications
We Are Your Analytical CDMO Partner
Whether you’re looking for standalone analytical testing or an integrated CDMO partner, Cytovance delivers flexible analytical solutions backed by experienced scientists, collaborative project management, and decades of biologics expertise.
Talk with our analytical team about your program today.
Related Areas of Expertise
Process Characterization
Identification of critical process parameters for a successful scale-up.
Microbial Manufacturing
Benefit from our full-service CGMP facility with up to 1,000L microbial capacity.
Mammalian Manufacturing
Benefit from our full-service CGMP facility from cell banks to production with up to 2,000L capacity.
