Biopharmaceutical Analysis Services

Detailed characterization of biopharmaceuticals meeting ICH Q6B guidelines

Our Biopharmaceutical Analysis Services are tailored for research, development of manufacturing processes, and clinical development of protein biotherapeutics. This includes analysis specifically designed for recombinant proteins, monoclonal antibodies, vaccine antigens, allergens, and host cell proteins.

When you need high quality analysis of your protein product, the Biopharmaceutical Analysis Services provide timely results in analysis reports customized to your biomolecule and process development stage.

We follow the principles for analysis of identity, purity, quantity, as well as product- and process-related impurities as described in the ICH Q6B guidelines: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products.


Choose between the following categories of biopharmaceutical analysis services:

Physicochemical Properties  >
Determination of MW, extinction coefficient, electrophoretic and liquid chromatographic pattern.

Structural Characterization  >
Determination of amino acid composition, amino acid sequence, and the N-and C-terminal amino acids.

Post Translational Modifications  >
Determination of disulfide bridges and glycosylations.

Host Cell Protein Analysis  >
HCP analysis for bioprocess optimization, clinical batches, and for quantification.

Antibody Characterization  >
Determination of molecular weight, disulfide analysis, peptide mapping, and de-novo sequencing.

Protein Quantification  >
Quantification of protein content by amino acid analysis or by MRM LC-MS/MS.


How to order Biopharmaceutical Analysis Services (click for details)

It is easy to order biopharmaceutical analysis from Alphalyse

  • High quality biopharmaceutical analysis meeting ICH Q6B guidelines
  • Choose standard methods or send us a project proposal request for analysis customized to your needs
  • Timely results in easy-to-understand reports

Newsletter Subscribe to the Alphalyse Newsletter to get 3 tips
about protein analysis methods and applications
Private, secure, spam-free
© Copyright Alphalyse , Inc. 2002 - 2018. All rights reserved.