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


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CASE STUDY 1
Parenteral dosage form development of a highly insoluble molecule
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CASE STUDY 2
Salt form optimization and lyophilized parenteral formulation development
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CASE STUDY 3
Oral liquid formulation development
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CASE STUDY 4
Accelerated stability studies to support a screening IND
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CASE STUDY 5
Lead Optimization: Solubility and formulation screen for efficacy and PK studies

Analytical Characterization

Wolfe Laboratories Inc. will develop and qualify a range of analytical methods for clients or install and qualify existing methods. We have extensive experience in preformulation and we can develop liquid, lyophilized, dispersed systems, solids, and semi-solid dosage formulations. We will work with manufacturing sites to seamlessly transfer process technology. Because of our extensive experience, we will work with discovery groups to provide research and development support that is atypical of most CROs. Wolfe Laboratories Inc. is eager to take on the wide variety of challenges inherent to preclinical pharmaceutical development. Our strong background in analytical chemistry allows us to produce efficient, quality data.

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

 

 

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