Wolfe Laboratories - From Concept to Creation with Confidence

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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

Articles and Resources

Regulations Still Driving Stability Testing, Genetic Engineering and Biotechnology News
Featuring, John Augustine, Ph.D., Principal Scientist, Wolfe Laboratories, 1 Apr 2008
… “By the preformulation stage, it may already be too late to set up a stability study,” observes John Augustine, Ph.D., principal scientist at Wolfe Laboratories…

A Brief Introduction to Extractable's & Leachables: Or, Is There Something Extra in My Drug Product?
By Nicole Damour-Krilla, Project Manager, Wolfe Laboratories, 9 Nov 2007
…as the API and its formulation are optimized, so should the storage conditions, which include the container-closure system... (that) should guarantee the protection, compatibility, safety, and performance of the drug product.

Dose Recovery: Identification of a Problem and its Resolution
By Dr. Nicolas S. Mourier, Principal Scientist, Wolfe Laboratories, 12 Sep 2007
…compatibility study with these diluents and administration sets from various providers can reveal losses in dose recovery when the test article is evaluated for up to 48 hours at the targeted high and low concentrations.

On Pre-Formulation and Formulation: Defining the Universe of Discourse
By Dr. Michael Frid, Principal Scientist, Wolfe Laboratories, 5 May, 2007
… pre-formulation refers to the physicochemical characterization of a compound and formulation refers to the development of a customized dosage form for a specific administration route.