Protein Formulation and Stability

J. Jeff Schwegman, Ph.D.

Dr. Marie-Eve Beaulieu

Course description

A significant portion of the pharmaceutical and diagnostic discovery groups are currently focusing on the development of biologically based molecules, such as monoclonal antibodies, proteins, and enzymes. These products, unlike small molecules, are highly susceptible to the usual stresses encountered during the product’s shelf life and manufacturing process.

The success or failure of these products depends on various factors, including their formulation (such as stabilizers, surfactants, and pH) and the processing methods employed (such as reduced oxygen, lyophilization, spray drying, and minimizing shear).

This accredited training will begin with a brief overview of basic protein chemistry and degradation pathways followed by a short discussion on the different upstream techniques for growing and purifying the biomolecules of interest. The requirements for starting the development process will then be broken down followed by an in-depth discussion of the analytical tools necessary for development and finished product testing.

A discussion on the formulation development process for a biomolecule will be had, which will cover pre-formulation and formulation development strategies utilizing high throughput screening techniques. Process development will be discussed, including product compatibility with manufacturing equipment/product contact components, and lyophilization and spray drying as a means of long-term stabilization.

A section will be dedicated to discussing the importance of container closure systems and potential interactions with the product, followed by a discussion on aggregates and particulate matter issues and concerns.

Course Topics Include:

• Protein Chemistry
• Recombinant Protein Creation
• Lyophilization/Spray Drying Techniques
• Injectable Drug Products
• Process Development
• Container Closure System

Upon completion of this course, you will be able to:

• Describe the complete process of developing stable biomolecule-based products including injectable drug products, diagnostics, and the like
• Explain the basics of recombinant synthesis, analytical requirements, pre-formulation, and formulation development strategies, process compatibility, and finished product manufacturing techniques including Lyophilization and  spray drying
• Monitor and control aggregation during and after the manufacturing process