Wolfe Laboratories Inc. is the acknowledged leading provider of early drug development services to the global biopharmaceutical industry. Its client base is comprised of global pharmaceutical and biotechnology companies. Wolfe Laboratories’ expertise and processes are uniquely designed to rapidly characterize a compounds’ pharmaceutical and biopharmaceutical properties and strategically leverage the knowledge gained to de-risk the innovative therapeutics, while working within the time-constrained early development paradigm.
Wolfe Laboratories’ services encompass analytical, pre-formulation, formulation, drug metabolism and pharmacokinetics, with streamlined transitions to GLP- and GMP- testing, obviating the need for time-consuming technology transfers and ensuring that programs rapidly advance to nonclinical and clinical evaluation. Wolfe Laboratories’ expert team is experienced in the successful development of parenteral formulations, enabling formulations, biologics, small molecule-macromolecule hybrids, protein-lipid complexes and high potency compounds, all of which are technically demanding and have limited API.
To download our comprehensive brochure of IND-enabling services, click here.
Integrated Lead Optimization and IND-Enabling Programs
In synchrony with our business focus, we offer at the highest level, full IND-enabling program support and management for the transition of candidate therapeutics from lead optimization to early clinical development in the pharmaceutical research and development continuum.
A complement of lead optimization screening tests are provided spanning in vitro ADME, physicochemical characterization, and early pre-formulation to identify lead molecules for progression into the pre-clincial safety evaluation typical of the IND-enabling phase. Screening test results are rapidly delivered with interpretative input that guide informed drug-like molecule selection.
IND-enabling programs involve application of internal expert services across pre-formulation, formulation and analytical development, and DMPK that are coordinated with external collaborating organizations providing active pharmaceutical ingredient manufacture, toxicology, and safety pharmacology to deliver, in a seamless and program managed manner, an integrated program of studies that facilitate IND filing for early clinical entry.
In Vitro ADME and Pharmacokinetic Support
We have a number of in vitro ADME
(absorption, distribution, metabolism and excretion)
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 modern 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.
We have extensive experience in pre-formulation 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.
Cytotoxic and High Potency Facility
We have a high potency facility and experienced staff capable to handle cytotoxic compounds. With 700 square feet of dedicated laboratory space, two four-foot hoods vented outside, 100% fresh air intake, and limited access, Wolfe Laboratories operates under the safest conditions when dealing with highly potent, cytotoxic compounds.
GLP and GMP Services
We recently expanded our service coverage into GLP- and GMP-compliant activities within the CMC and bioanalytical areas of operation, and are in the process of establishing GMP aseptic processing. We are now better positioned to serve clients' needs as they progress into IND-enabling pre-clinical work and early clinical development studies.