Our Biopharmaceutical Analysis group offers a wide range of techniques to facilitate a multi-disciplinary approach for analysis and characterization of protein, peptide, and oligonucleotide drug candidates.
Our Biopharmaceutical Analysis capabilities include:
- Preformulation, formulation, and manufacturing
- Structural characterization
- Method development, qualification, and validation
- Global release and stability testing
Analytical Techniques
We have a wide range of analytical techniques that provide us with a multidisciplinary approach to the analysis and characterization of protein, peptide, and oligonucleotide drug candidates:
Preformulation, Formulation, and Manufacturing
We provide formulation development for parenteral drug products. We can streamline transition from formulation development to manufacturing with an on-site aseptic manufacturing suite. Our highly qualified scientific staff can provide product development, characterization, and testing services at one site.
Structural Characterization
We have characterization experience with peptides, proteins, and glycoproteins, including monoclonal antibodies and oligonudeotides. Our techniques include mass spectrometry, peptide mapping, circular dichroism, amino acid analysis and sequencing. In addition, we provide oligosaccharide analysis including monosaccharides, sialic acids, sequencing, and linkage determination.
Method Development, Qualification, and Validation
Our scientists will develop new methods and optimize existing methods for drug substance and drug product. Your biopharmaceutical test methods can be easily transferred to our laboratories for successful qualification and validation according to requisite guidelines and the drug development stage.
Global Release and Stability Testing
Because our scientists have experience in worldwide biotechnology development, your biopharmaceutical product can be release-tested for global use at our facilities in the US or Europe. Clinical, registration, and commercial drug product lots are tested and monitored for shelf life in our state-of-the-art stability chambers, all validated to meet any ICH condition.