Biologic Quality Control & Stability

Reliable methods to test your product.

Your commercial program will be accelerated by leveraging our expansive in-house analytical capabilities, technologies, and knowledge to deliver methods tailored to your molecule of interest.

Contact Us

Accelerating your path, we develop, execute and document phase appropriate methods necessary to produce high-quality, well-characterized material and the data to support successful BLA and marketing applications.

End-to-end support

Applying our expertise and experience, we develop data packages that support your regulatory approvals with all global agencies.

Our in-house analytical approach focuses on qualifying phase appropriate assays for a spectrum of testing including: safety, potency, purity, identity, and extended characterization that enable end-to-end support for:

  • Formulation
  • GMP manufacturing
  • Release and stability testing for GMP material

Our Capabilities

We provide transparent and regular communications to ensure we meet your program goals and timelines.


  • Protein A, L, G, CH1, affinity and custom solutions​
  • Biolayer Interferometry


  • CESDS (reduced and non-reduced)​
  • SDSPAGE (reduced and non-reduced)
  • Western Blot​
  • SE-(u)HPLC
  • UV/Vis Spectroscopy​
  • Residual Protein A​
  • Residual Host Cell Protein



  • Antigen binding ELISA​
  • Biolayer Interferometry​
  • UV-Vis spectrophotometry​​


  • Appearance (USP<790>/EP2.9.20), (USP<631>/EP2.2.2), (USP<855>/EP2.2.1)​
  • Osmolality (USP<785>/EP2.2.85)​
  • pH (USP<791>/EP2.2.3)​

Extended Characterization Analyses​

  • Intact Mass
      • Native intact mass​
      • N-deglycosylated intact mass
  • Reduced Subunit Intact Mass​
      • Native reduced subunit intact mass
      • N-deglycosylated reduced subunit intact mass​
  • Peptide Mapping​
      • Amino acid composition
      • Oxidation, Lysine Clipping​
      • Acetylation, Sulfation, Phosphorylation​
      • Deamidation, Pyroglutamate formation
      • Glycation
  • Disulfide bond mapping​
  • Free sulfhydryl determination​
  • Glycopeptides​
    • N- and O- Linked glycan site mapping​
    • Glycan site occupancy​
  • Released N- and O-linked glycan identity and structure​
  • Quantification of Fucosylation​
  • Monosaccharide analysis​
  • Sialic acid content​
  • Glycan linkage analyses


  • Residual Ligand ELISA (Kit Based)​
  • Endotoxin (LAL), (USP85 / EP2.6.14)​
  • Sterility
  • Bioburden
  • Mycoplasma 
  • Mycoplasmastasis


Offering a full spectrum of services, we support stability studies for drug substance, drug product and in-use testing per ICH guidelines.

Stability indicating assays are identified early on via forced degradation studies performed during process development.

Following completion of stability time point testing, a final stability summary report is provided to support your clinical studies and market authorization applications.

Contact Us