How A Functional Equivalence Guide For Single-Use Technology Will Actually Save Time And Money

By JoAnne Jacobs, Director of Technical Services, INCOG BioPharma Services

Jo Anne Jacobs, Director of Technical Services at INCOG BioPharma Services, discusses building a functional equivalence model for single-use manufacturing equipment and assemblies for use in drug product manufacturing.

The concept of “functional equivalence” has been accepted in clinical practice with respect to drug products for many years. This is different from substituting a “generic” version of a brand-name product. In this case, a completely different active substance is substituted for the product ordered by the physician. This didn’t happen overnight, as a controlled and well-defined process for this had to be developed and proven to be safe. Being a pharmacist, I have always had a difficult time understanding why this concept couldn’t be applied in pharmaceutical manufacturing.

I want to plant the seeds for developing a functional equivalence model for single-use manufacturing equipment and assemblies for use in drug product manufacturing.