Instrumentation and Techniques

BioPharmaSpec scientists use state-of-the-art instrumentation and technical expertise built up over many decades to provide you with a full range of cost-effective protein characterization services.

In our global laboratories we use a range of chromatographic, electrophoretic and mass spectrometric techniques to provide meaningful structural, physicochemical and biophysical characterization data. This data enables you to gain knowledge about the structure of your biopharmaceutical product of interest and to make informed manufacturing and process control decisions. Analytical data is vitally important in many areas of drug development such as:

  • Clone selection
  • Structural and physicochemical characterization to ICH Q6B
  • Comparability studies
  • Biosimilarity studies
  • Forced degradation studies
  • Stability studies
  • Product and process impurity analysis and quantitation (e.g. host cell protein (HCP) detection by MS).

Our clients use the data we provide from the above studies to make key development decisions and ultimately bring a well characterized and safe biopharmaceutical to the market.

Our Instrumentation

BioPharmaSpec shares a common regulatory view that biopharmaceuticals should be characterized using the most advanced techniques available. We are committed to remaining at the forefront of emerging technologies and can help you understand the best instruments and methods to analyze your biopharmaceutical.

See our List of Instrumentation.

Techniques

Chromatography and Electrophoresis

BioPharmaSpec scientists use various chromatographic and electrophoretic techniques to separate components within your biopharmaceutical (e.g. higher or lower molecular weight species or differently charged species). This separation allows more specific and efficient characterization of isolated components from samples.  For example, Ion Exchange Chromatography can be performed to collect specific fractions of differently charged species for further mass spectrometric (MS) analysis. This MS analysis will provide greater information on the components in these fractions, such as molecular weight, amino acid sequence and post translational modifications (PTMs).

BioPharmaSpec is proficient in a variety of chromatographic and electrophoretic techniques and can apply these to your biopharmaceutical product to provide quality physicochemical characterization data.

BioPharmaSpec also provides a method development service for specific chromatographic methods for the isolation and subsequent characterization of components of interest in a sample.

Mass Spectrometry

BioPharmaSpec scientists have contributed extensively to field of mass spectrometry, including pioneering the design of the Quadrupole- Time of Flight (Q-TOF) geometry for high resolution mass spectrometry (MS).  Our scientists have also developed numerous common MS methods including the basic concept of mass spectrometric peptide mapping and the first MS glycoprotein strategies which led to efficient procedures for N- and O-linked oligosaccharide MS analysis.

BioPharmaSpec’s global laboratories are equipped with a large range of mass spectrometers which are used for a comprehensive range of protein characterization services. This state-of-the-art instrumentation facilitates both qualitative protein and glycoprotein mass spectrometry and quantitative mass spectrometry.

  • Q-TOF Mass Spectrometers with ES and Nanospray and TripleTOF Mass Spectrometers
    • Peptide mapping
    • Intact molecular weight analysis
    • Identification and quantitative analysis of host cell proteins (HCPs)
    • Disulfide bridge analysis
    • Analysis of post translational modifications
    • Analysis of residuals
  • TQ-S Mass Spectrometers
    • Quantitative analysis of HCPs and residuals
  • MALDI TOF/TOF Mass Spectrometers
    • Intact molecular weight analysis
    • N- and O-glycan analysis
  • Gas Chromatography Mass Spectrometers
    • Glycan analysis
    • Quantitative analysis of residuals