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.
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.
Make our labs, your labs.
Contact our scientists now to understand how we can use our protein characterization methods to accelerate the development of your molecule.