Wolfe Laboratories - Protein Characterization

Analytical Method Development
Protein Characterization
Solid-State Characterization
Stability-Indicating Analytical Methods
Identification of Impurities and Degradation Products
Additional Analytical Applications

>	CASE STUDY 1 Advancement of an Early Development Candidate to Phase IIb Trials
>	CASE STUDY 2 Development of a Parenteral Formulation of a Cytotoxic Natural Product
>	CASE STUDY 3 Oral Formulation Development for Proof-of-Concept Animal Toxicology Studies
>	CASE STUDY 4 cGMP Analytical Release Testing of a Cytotoxic Drug, as Well as Other Analytical and Bioanalytical Services
>	CASE STUDY 5 Parenteral Dosage Form Development of a Highly Insoluble Molecule

Protein Characterization

Protein characterization may require several assays that address the composition, purity, modification, functionality, and other properties of a therapeutic protein.

WLI offers a variety of protein analysis services based on HPLC-MS/MS techniques. The depth of characterization of a protein ranges from simple molecular weight determination to extensive characterization based on project requirements.

We specialize in developing peptide maps and providing clear, comprehensive documentation for major and minor components to support protein development programs or FDA submissions. Moreover, using modern mass spectrometric techniques, database searching, and de novo sequencing, WLI can provide information on a variety of post-translational modifications.