Analytical Development Support
Our Analytical Development Laboratory has the expertise to develop robust analytical methodologies to meet your individual product requirements.
In addition to developing product specific methods, our staff has extensive experience in transferring and optimizing methods developed at virtually any stage, including qualification and validation. We also offer several platform method technologies which we can evaluate to be potentially suitable methods for your product, which can in turn, decrease method development time and overall project costs.
We can develop analytical methods for a wide range of proteins, including monoclonal antibodies, enzymes, growth factors, complex glycoproteins, and other recombinant models.
- Analytical method development and validation
- Sterility testing
- Membrane filtration
- Direct inoculation
- R&D stability studies
- ICH stability testing
- Stability-indicating assay development
- In vitro release studies
- Method transfer through technical packages
- Residual solvent determination
- Moisture content analysis
- In-process testing
- Extractables and leachables
- USP particulate testing: HIAC
- Liquid Chromatography (HPLC) – DAD detector, Fluorescence Detector
- Ultra-Performance Liquid Chromatography (UPLC) – PDA detector, Mass-Spec detector (Single Quad)
- UV-Vis and IR spectroscopy
- Karl Fisher Moisture Analysis (KF)
- pH Meter
- Stability Chambers
- USP Particulate Testing: HIAC
- Sartocheck 4 (Filter Integrity Testing)
In addition to traditional analytical support, we also offer and manage other specialized development and validation work through our service partners. Some of the techniques include mass spectrometry, amino acid & carbohydrate analysis, terminal sequencing, and CMC/regulatory support services.