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.
Services Overview:
- BCA /Bradford protein assays
- A280 protein determination
- UV-Visible spectral scanning
- pH
- Fluorescent activity assays
- ELISA assays
- HPLC-affinity, IEX, HIC, SEC, RP-HPLC
- SDS-PAGE analysis
- IEF analysis
- Western blot analysis
- LAL Endotoxin assays
- Bioburden determination
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.