Remember – at checkout you can choose to take this course On-demand. We offer a 10% group discount when you register 2 of more attendees (up to 10). Contact us for larger groups.

Many of the new molecules being developed by pharmaceutical and diagnostic discovery groups are biologically based, including monoclonal antibodies, proteins, enzymes, etc. Unlike small molecules, these products are much more sensitive to the normal stresses that a product encounters both over the shelf life of the product and during the manufacturing process.

Both the formulation (stabilizers, surfactants, proper pH) and how the product is processed (reduced oxygen, lyophilization, spray drying, minimizing shear, and others) can have an impact on the success or failure of a product.

This 12-hour, accredited ON DEMAND 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.