Wolfe Laboratories - Analytical 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 Parenteral dosage form development of a highly insoluble molecule
>	CASE STUDY 2 Salt form optimization and lyophilized parenteral formulation development
>	CASE STUDY 3 Oral liquid formulation development
>	CASE STUDY 4 Accelerated stability studies to support a screening IND
>	CASE STUDY 5 Lead Optimization: Solubility and formulation screen for efficacy and PK studies

Additional Analytical Applications

In addition to the analytical characterization assays described in individual sections, a variety of auxiliary, complimentary assays may be required, depending on the needs of a particular program.

WLI operates analytical equipment to collect measurements on properties of drug substances and vehicles that are relevant to the drug development process. Assays based on these analytical techniques commonly are used to support WLI projects or are available on a fee-per-sample basis.

WLI provides additional analytical applications with a variety of drug substances, including small molecules, peptides, proteins, oligonucleotides, and cytotoxic materials.