Cell Line Development (CLD)Analytical Method DevelopmentFormulation DevelopmentProcess Development and Manufacturing

Analytical Method
Development

Reliable methods to characterize your product

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

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Accelerating your path to the clinic, we develop, execute and document phase appropriate methods necessary to produce high-quality, well-characterized material and the data to support successful IND and marketing applications as you move towards commercialization.

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

Our Approach

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

  • Design and developability
  • Cell line development
  • Formulation development
  • Upstream and downstream process development
  • GMP manufacturing
  • Release and stability testing for GMP material

Our global team of expert analytical scientists develop analytical test methods and analytical qualification protocols, leveraging state-of-the-art instrumentation and a molecule-specific, customized approach to method development, qualification, and testing.

Methods can be developed de novo or transferred in from external laboratories.

By understanding your molecules’ attributes, we support future development activities with customized characterization assays.

Once methods are established, we optimize and refine them for the molecule of interest as part of an integrated service that supports cell line, process, and formulation development, and/or bioconjugation.

We provide transparent and regular communications to ensure we meet your program goals and timelines. Our capabilities include:

Viral clearance studies

  • Viral clearance studies

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​
  • rProtA​
  • Residual HCP​​

Potency​

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

Compendial​

  • Appearance (USP790/EP2.9.2), (USP631/EP2.2.2), (USP855/EP2.2.1)​
  • Osmolality (USP785/EP2.2.85)​
  • pH (USP791/EP2.2.3)​
  • Extractable Volume​

Extended Characterization Analyses​

  • Intact Mass
    • Native intact mass​
    • Intact N-deglycosylated
  • Reduced Subunit Mass​
    • Native reduced intact mass
    • Reduced Subunit N-deglycosylated
  • 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
  • TEM
  • Mycoplasma
  • Mycoplasmastasis

Cell-Based Assay Development

  • Fcg and neonatal Fc Receptors​
  • Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC)​
  • Complement Dependent Cytotoxicity (CDC)​
  • C1q Binding
  • Antibody-Dependent Cellular Phagocytosis (ADCP)​
  • Custom Cell-Based Assays
  • Viability, Cytotoxicity, Apoptosis​

Small Molecule Characterization​

  • 1D and 2D NMR​
  • Mass Spectrometry

Antibody-Drug Conjugate Characterization​

  • HPLCESIMS​

Instrumentation

  • Mass Spectrometry​
  • Liquid Chromatography​
  • Capillary Electrophoresis
  • ELISA and Bioassay​
  • NMR Spectroscopy

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Work with us

We leverage our expansive in-house capabilities, technologies, and molecule-specific methods to create a customized approach to method development ensuring your overall success in delivering vital medicines to patients.