Services Overview

Wolfe Laboratories provides a wide range of services to meet the needs of our clients. Each project is tailored to meet the scientific needs and timeframes of our clients, however our services are grouped into three main categories.

In vitro ADME and pharmacokinetic support

We have a number of in vitro ADME assays available to help identify the compound with the right balance of properties to move into pre-clinical development.  Typical assays include plasma and metabolic stability, protein binding, permeability, as well as individual CYP450 profiling.

Our state-of-the-art HPLC/MS/MS capabilities allow us to develop highly sensitive and specific quantification methods for test compounds in a variety of biological matrices to support sample analysis from PK studies.  In addition, we can conduct metabolite identification using both in vitro and in vivo samples.

Analytical characterization studies

We develop and qualify a range of analytical methods for clients or install and qualify existing methods to be used for subsequent formulation development or stability testing activities.   In addition to developing stability indicating analytical methods, we identify impurities and degradation products from solid API material, as well as formulated product using HPLC/MS/MS.

We develop appropriate methods to characterize small molecule using a variety of solid phase techniques, as well as for proteins, including molecular weight determination and peptide mapping.

Formulation development

We have extensive experience in preformulation and can develop liquid, lyophilized, dispersed systems, solids, and semi-solid dosage formulations.  Using the pre-formulation data, we work with our clients to develop a formulation that meets the pharmacology, toxicology and clinical requirements.  We develop injectables, both liquid and lyophilized, oral solids, liquids and dispersed systems, and topical formulations, depending upon the program requirements.

We provide a range of stability testing services, including stability under ICH conditions and can identify degradation products using our HPLC/MS/MS instrumentation.

We work with manufacturing sites to seamlessly transfer process technology and can support finished product testing and product complaints.