Product characterization

Our aim is to provide you with the best protein analysis service by providing access to our service-minded team of highly experienced and skilled scientists, hand-picked from leading universities and companies. Together, they cover most fields of protein chemistry, mass spectrometry, and bioinformatics. They also apply top-of-the-line equipment and are experts in interpretation of its data for biopharmaceutical protein characterization.


Product characterization

Product and attribute characterization

To comply with ICH Q6B guidelines, regulatory documentation for new protein-based biologic substances and products should provide structural characterization (including truncations, cleavage sites, and major degradants) and an overview of physicochemical properties.

In addition, comparability and stability studies are required for quality assurance/quality control (QA/QC).

Mass spectrometry enables reproducible, quantifiable intact mass analysis, peptide mapping, and amino acid analysis for product and quality attribute characterization.

Protein characterization services

Intact mass analysis and peptide mapping

Amino acid analysis for protein quantification

Protein analysis for comparability

Accelerated stability and forced degradation

Examples of biologics we analyze

Recombinant proteins

Recombinant proteins

  • Enzymes
  • Hormones
  • Fusion proteins
Antibody analysis


  • Monoclonal (mAbs)
  • Biosimilars
  • Bispecific (bsAbs)
Viral vaccines


  • Live attenuated
  • Recombinant VLP
  • Inactivated
Advanced therapy analysis


  • Adenovirus
  • AAV
  • Lentivirus
Bacteriophage product analysis

Bacteriophage products

  • Process samples
  • DS batches
  • Phage cocktails

Typical project timeline

Two Alphalyse scientists analyzing complex data
  • Facilitate meetings

    Facilitate meetings to define the project scope and agree project proposal

  • appoint-assign-blue

    Assign an experienced project leader to your project to fulfill the project objectives, ensure timely delivery, and keep your team updated on progress

  • SWATH LC-MS analysis and protein quantification using amino acid analysis

    Provide reproducible data using advanced instruments and robust workflows, with SOPs in place for all analyses to ensure the highest quality

  • Follow up on reports

    Follow up the report with an online meeting to review the results and answer your questions

Talk to us

Whatever protein-related challenge or question you may have, we would love to help. Our experts can help you decide on the best analytical approach for your project by email or online meeting - providing advice without obligation.

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