Stability Studies

Analytical Expertise and Tools to Support Biologics Development and Manufacturing

Analytical Sciences

Analytical Expertise and Tools to Support Biologics Development and Manufacturing

Bionova’s analytical sciences group actively engages with our internal cell line development, upstream and downstream process development, formulation development and GMP manufacturing groups to provide analytical support to all client programs.

Non-GMP Development Support Services

  • Method development and qualification
  • Standalone product quality assessment
  • Upstream and downstream process support
  • Formulation evaluation
  • Stability studies (accelerated and real time)
  • Protein characterization
  • General troubleshooting

Analytical Support for GMP Operations

  • Qualification of assays (Phase I-II)
  • Running assays in QC lab
  • Validation of assays for Phase III programs

Assay Development

Method development and all testing and characterization assays are handled inhouse to ensure quality, control and speed (viral testing is done externally).

Instruments and Tools

Our analytical labs are equipped with an array of instruments you’d expect to see at a much larger company. And when a client project requires it, we don’t hesitate to invest in new tools to get the job done.

A Cultural Commitment to Finding the Best Pathway

The open culture among our analytical sciences team encourages collaboration and fresh thinking. Never complacent, we are always seeking to determine the best way to accomplish the needed analysis.

Assay Repertoire

Bionova’s broad assay repertoire is suitable for process effect screening studies, process optimization, comparability studies, defining Critical Quality Attributes for in-process and release testing, and final product stability evaluation.

  • Titer Determination
    • HPLC (ProA/ProL affinity, RP, SEC)
    • Octet RED96 using various type of BLI sensors
    • Quantitative ELISA
    • BCA total protein assay
    • A280 by SoloVPE for purified proteins
  • Purity Assay
    • Product related impurity
      • Size exclusion HPLC, HIC HPLC (aggregation/fragmentation)
      • CEX HPLC, icIEF, cIEF, CZE (Charge variants)
      • CE-SDS, SDS-PAGE (IgG purity)
      • Peptide mapping, LC/MS
    • Process impurity (safety)
      • HCP/ProA ELISA
      • Endotoxin level
      • Mycoplasma testing
      • Sterility Testing
      • Particle counts
      • Osmolarity
    • Structure Assay
      • Glycan profile
        • Total released N-glycan profile (2AB labelling/HILIC HPLC/LC/MS)
        • Total sialic acid content (DMB labeling/RP HPLC)
        • Sialylated N-glyan profile (2AB labelling/AEX HPLC)
      • Primary Structure (LC/MS)
        • Intact proteins MW
        • Peptide mapping
          • Amino acid sequence confirmation
          • N-terminus and C-terminus amino acid
          • Disulfide linkage, glycosylation site(s)
        • Amino Acid Analysis
      • Physical Property
        • DSC
        • CD
        • FTIR
      • Potency
      • Binding assay
        • KD by Octet
        • ELISA
        • Flow cytometry
      • Cell based Potency Assay
        • ADCC
        • CDC
        • Cell Proliferation (e.g. TNF-alpha mediated cytotoxicity)
        • Intracellular Signal Transduction Indicating Pathway
        • Assay Development and Qualification per Mechanism of Action (MoA) for a product candidate

Bionova would love to hear from you.