The European Annual Conference of the International Society of Pharmaceutical Engineering (ISPE) attracted over 700 participants to Dublin from 1st to 3rd April 2019. The main topic was “Drive and Leverage Innovation for Pharma”. The Executive Forum focused on the industrial digitisation as a key enabler to drive innovation. Driving continuous improvement in a digital age needs a number of pre-requisites and face new challenges and opportunities.
In today’s leading article I have summed up the most decisive trends and future challenges as seen by the top-class lecturers in the executive plenary and keynote sessions.
I have also published this text (and much more) in my live coverage of the conference at Linkedin (#gmppublishing).
The first speaker was Pam Cheng from AstraZeneca who enthusiastically talked about digital technology and data. Regarding pharmaceutical manufacturing Pam highlighted:
Another key question of the first afternoon was: Can we predict future quality?
Pam reported on predictive maintenance that AstraZeneca introduced for a packaging line in Sweden. Line failures can be predicted – you can intervene before things fail.
„New half-live of a skill is 5 years!“
Pam recommended to look at the digital things that surround you. That means continuous learning is the most important factor.
Last but not least, people are one of the key success drivers for the factory of the future!
Thomas Wozniewski, as the global head of operations for all technologies and factories from the new Takeda/Shire operations, gave his perspective on global relevant success factors for manufacturing and quality.
He referenced a new living stemcell product, Alofisel®, that is challenging for many reasons, e.g. shelf life, storage temperatures, batch size, timing of production (directly before surgery). Tests on sterility are quick tests, or the release is conditional before the results of the test are available.
There are digital supply chain solutions for Alofisel®: a nurse can go in with an app and book a production slot. You get even real time feedback from the hospital about the condition of the patient.
„There are 4 major industry trends.“
Trend 1: Changing technologies
Trend 2: Drug product & device combination
Trend 3: Changes in regulatory framework result in shorter development time: fast track approvals
Trend 4: Environmental sustainability matters!
Big data and digitalisation will have great influence on global manufacturing and supply.
Brendan O'Callaghan from Sanofi started the keynote sessions with his lecture on Developing Next Generation Biologics. Brendan introduces Sanofi’s strategy for future manufacturing that includes:
A new US site that realizes integrated continuous biomanufacturing has the following advantages:
Digital technology is one prerequisite for a factory of the future. Brendan mentioned in this context:
With its new facility, Sanofi has already realized the factory of the future!
2019 ISPE Europe Annual Conference:
Pam P. Cheng, Executive Vice President – Global Operations & IT, AstraZeneca: Global Success Factor: Innovation and Digitisation
Thomas Wozniewski, Global Manufacturing & Supply Officer, Takeda: The Transformation of Global Manufacturing and Supply at Takeda
Brendan D. O'Callaghan, Senior Vice President & Global Head Biologics Platform, Sanofi: Developing Next Generation Biologics
Sabine Paris, PhD
Maas & Peither AG – GMP Publishing