Process Track RecordTechnology TransferPPQ – Process, Production & QualificationCommercial ManufacturingQuality Control & StabilityRegulatory

Quality Control
& Stability

Reliable methods to test your product

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.

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.

Get in touch

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.

Titer/Productivity

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

Purity/Identity

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

​​

Potency

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

Compendial​

  • 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

Safety

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

Stability

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.

Get in touch