Rocky Mountain Regional Center of Excellence

Preliminary Characterization/Formulation

What is characterization/formulaton?
Pre-formulation processing includes physical and physcio-chemical properties of bulk active ingredient and major excipients.  The basic principles and problems of formulation of pharmaceutical, vaccine and diagnostic products will be coordinated by the Translational Development Subcommittee and addressed by the PDM Core Product Development Manager via FDA and ICH Guidance documents, and interaction/outsourcing with Formulation Experts, as needed.

 

Product characterization includes developing an aggregate of methods to describe the character or quality of an intermediate or final product.  PDM Core personnel will consult FDA and ICH Guidance documents, pharmaceutical and/or biotechnology company contacts, and regulatory consultants to meet quality standards outlined in the CGMP regulations.

PDM Core Services

Service 1:
Characterization of master seed stock

Service 2:
Characterization of product

Service 3:
Development of formulation strategies

What do I need to do?
Please contact the PDM Core for specifics on the program, material and shipping requirements, and individualized service agreements.

E-mail inquires, questions, and orders to:
Becky.Rivoire@colostate.edu