Pharmaceutical Manufacturing Execution Systems: Speaker Interview

Brian DiVasta
Principal Validation Engineer
GENZYME

Brian will be one of the distinguished speakers at the 3rd Annual Pharmaceutical Manufacturing Execution Systems Conference.

What are your main objectives for attending the 3rd Annual MES Conference?

My primary objective is to gather best practices form other participants and share my own experiences (good and bad); in the past 2 conferences, we have discussed topics like standardization and building for scale and just from the first to second conference, I saw tremendous development on those topics.

Are you aware of an upcoming automation or MES trends?

Standardization and implementation using an “MBR-Factory” seem to be all the rage!

What successes have you and your team experiences with MES?

We have had varying degrees of success with implementation of a core model and use of said “MBR-factory” – most of our challenges were procedural and administrative, rather than technical – our methods have to mature to adapt to the changing use of technology.

What is the practical reality of standardization – is this something the industry can achieve?

I do think standardization is achievable – to an extent; there are obvious specificities and variances between biological processes, but even in that arena, there are elements of the manufacturing process that are similar enough to justify and take advantage of standardization.  Further, with appropriate design of records (limiting content to critical parameters and minimizing qualitative information) you can further drive standardization.  We will be testing this theory over the next year!

Is there any new software or technologies you are interested in hearing more about?
Nope!

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