Process Track RecordTechnology TransferPPQ – Process Performance & QualificationCommercial ManufacturingQuality Control and StabilityRegulatory

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.

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.

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

Our approach focuses on developing and qualifying phase appropriate assays and extended characterization that enable end-to-end support for:

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

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

Our capabilities include the following:

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

Small Molecule Characterization​

  • 1D and 2D NMR​
  • Mass Spectrometry
  • FTIR
  • RP, NP, HIC and Chiral HPLC
  • GC
  • Karl Fisher
  • DSC
  • DLS

Antibody-Drug Conjugate Characterization​

  • HPLCESIMS​

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.