Russell E. Madsen Jr.

Technologies in use and on the horizon could change aseptic processing in ways that seemed inconceivable years ago but approaches to aseptic process validation still need to move beyond their 1970s roots.

Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies.

A validation plan developed to support a process unrelated to bio- pharmaceutical manufacture is applied to bio- pharmaceutical processes and systems.

This is the first of a series of three articles about validation and technical transfer in the bio- pharmaceutical industry.