ISPE Expert Xchange: Enabling Pharma 4.0™ through Plug & Produce

Next-Generation Virtual Experience

Learning Level: Intermediate
Session Length: 3.5 hours


In this ISPE Expert Xchange: Enabling Pharma 4.0™ through Plug and Produce, we will assess opportunities and gaps for the digital transformation of bio-pharmaceutical manufacturing, including regulatory compliance aspects.

How do we translate bio-pharma business needs into digital reality? This ISPE Expert Xchange covers the bio-pharma specific aspects of the digital transformation specifically on machine, equipment, and device (sensor) integration for realizing the benefits of Pharma 4.0™. We present the latest insights and conclusions from the workstreams of the ISPE Pharma 4.0™ Plug and Produce workgroup. We will explain and demonstrate principles and technologies that enable Holistic Control Strategy that are based on integration of product, process, and manufacturing related data, including analytical lab results to address the pain-points experienced today. Practical examples from recent proof of concept projects and hackathons will be provided.

In addition, YOU get a seat at the table with these leading industry subject matter experts and your peers during the interactive topic-focused small group discussions where you will gain first-hand strategic insights and walk away with new connections, and actionable takeaways that will directly impact you, your organization, and the pharma industry. 

First-hand Strategic Insights & Actionable Takeaways

  • Learn what business outcomes Pharma 4.0™ enables
  • Learn what architectural and design principles are behind Pharma 4.0™
  • Learn how to approach Pharma 4.0™ Plug and Produce integrations based on practical PoC implementations
Small group Discussions
Small Group Discussions
Technical Presentation
Technical Presentations
Case Studies
Case Studies
Problem-Solving
Problem-Solving

Agenda

Thursday, 10 June 2021
  • 0900 – 0905
    Welcome
    Josef Trapl
    Head of MSci Innovation, GMS / Manufacturing Science
    Takeda Pharmaceutical International AG
    Chair
  • 0905 – 0915
    From PAT to Holistic Control Strategy to Plug and Produce: How It All Started
    Christian Wölbeling, MD
    Executive Industry Advisor
    Körber Pharma Software
  • 0915 – 1000
    Pharma 4.0™ Plug and Produce Introduction
    Wolfgang Winter
    Director, Informatics Platform R&D
    Agilent Technologies R&D Mktg GmbH & Co KG
    Chair
    Josef Trapl
    Head of MSci Innovation, GMS / Manufacturing Science
    Takeda Pharmaceutical International AG
    Chair
    Kim Hewson
    Engineering Automation Solutions Director
    GSK
    Rod Hoffman
    Lead Manufacturing Business Analyst
    AstraZeneca
    Anton Granget
    Managing Director
    TechPivot GmbH
    Henrik Stellmann
    Senior Product Manager Integration
    Körber Pharma Software

    1. Introduction to the Pharma 4.0 Plug and Produce problem and solution space Presenter: Wolfgang Winter
      • How do we translate the business needs into the digital reality of Pharma 4.0?
      • What is needed for the integration of OT and IT?
      • How to approach Pharma 4.0 “Plug and Produce” in practice?
    2. Plug and Produce Architecture - In a world where IT technologies change at a fast pace, Pharma operators are faced with two major questions: Presenter:  Anton Granget, Kim Hewson
      • How to achieve fast, flexible and low-cost validated connectivity between machines, IT-systems and humans to find smart data-driven answers to use-cases all around the shop floor and enterprise?
      • How to ensure that what is being implemented today in terms of IT/OT technology is not doomed to become obsolete the day after the project is done?There is a consensus that the traditional „one-system-fits-all“ approach is legacy thinking. This leads to a paradigm shift from how to interconnect all the systems to how to create an architecture that can onboard new applications for innovative use-cases fast and in a validated manner. Also, today the typical business user faces the problem that data required for the realization of such use-cases must be pre-processed, which leads to a significant loss of agility and reactivity. The opposite of what we want.
    3. Specific requirements for Plug and Produce – How the shop floor will be supported by an intelligent and scalable infrastructure? –Presenter: Rod Hoffman, Henrik Stellmann, Josef Trapl
  • 1000– 1015
    Discussion, Questions and Answer Session
    Josef Trapl
    Head of MSci Innovation, GMS / Manufacturing Science
    Takeda Pharmaceutical International AG
    Chair
    Wolfgang Winter
    Director, Informatics Platform R&D
    Agilent Technologies R&D Mktg GmbH & Co KG
    Chair
  • 1015 – 1030
    ISPE Networking Coffee Talk

    This face-to-face forum gives you the chance to have 1:1 conversations in small groups via video chat. Connect with attendees and engage with the speakers about their topics during this networking break.

  • 1030 – 1115
    Pharma 4.0™ Plug and Produce Case Studies and Proof-of-Concept Projects
    Giuseppe Menin
    Industry Manager Pharmaceutical
    Ing. Punzenberger COPA DATA GmbH
    Martin Mayer
    Business Development Smart Engineering Services & Digitalization
    ZETA GmbH
    Christian Schoemer
    Senior Manager | Technology Strategy & Transformation
    Deloitte Consulting GmbH
    Henrik Stellmann
    Senior Product Manager Integration
    Körber Pharma Software

    1. PoC “Sensor, Machine, Equipment and system connectivity” – OPC-UA interface demo and discussion based on the newest published concept paper “Connectivity between shop floor & manufacturing operation management system OPC UA – a tangible step towards OPC-UA which presents a solution for standardizing an important aspect of plug and produce namely the transaction interaction between ISA 95 level 2 and level 3”. Presenter: Henrik Stellmann
    2. PoC  “Micro-service based integration between machines and IT systems” – Presenter: Giuseppe Menin. In this session we want to show a first practical step to realize a micro-service based integration between machines and IT systems in the frame of a proof-of-concept project. The approach is based around modularized connectivity services that are run in an application-neutral middleware component. Using a machine simulator with a full stack OPC UA capabilities, we will show how we intend to get away from a tag-based integration approach to a service-oriented one, with the use of a message broker. Our exemplary use-case is triggering a batch on the simulator machine. In mid-term we want to show how semantical abstraction within the connectivity micro-services can facilitate a decoupling of systems, thereby creating an interoperable, flexible and extendable architecture.
    3. PoC “Fermenter, Admin shell concept and Digital Twin” – Presenter: Martin Mayer, Christian Schömer As the PnP focused in different workstreams the focus of WS3 is considering the customer focus. From that point of view the idea was to including the findings of the other workstreams and realize it based on an equipment including all the environment typically found in industry (DCS, IT constraints, …) and combining it with use cases with the customer in focus. The use case we focus in the first step is formulated: As Head of Production, I want a new IoT temperature sensor integrated with my bioreactor and to be informed as soon as the sensor is going live – independent from where I am, by opening my production dashboard on my mobile.
      Based on that user needs we elaborated some focus topics to cover in the PoC:
      1. Architecture / IT Concept:
        • Roles of IT Systems/software packages, hardware devices, Structure: local - cloud
      2. Technical connectivity:
        • Fermenter: Standard OPC UA, Data Model Tag Based
        • Smart Sensor: Blue tooth 4.0 – Edge Device – MQTT to cloud
      3. Functionalities:
        • Auto log on/login of Smart Sensor/Edge Device - Security
        • Combination of Sensor Data and Fermenter data to ONE logical entity (Digital Twin)
        • Information on mobile device anywhere, anytime
      4. : Next Steps/Questions:
        • How does standardization (Admin Shell) support this concept?
        • How to structure complex equipment (Fermenter) via Admin Shell?The realization is currently ongoing at the TechCenter in Austria using a Stainless Steel Fermenter 60l, GMP compliant, fully automated, DCS including OPC UA connectivity, a cloud application, Edge Device and Sensor for the fermenter
  • 1115 – 1130
    Discussion, Questions and Answer Session
    Wolfgang Winter
    Director, Informatics Platform R&D
    Agilent Technologies R&D Mktg GmbH & Co KG
    Chair
    Josef Trapl
    Head of MSci Innovation, GMS / Manufacturing Science
    Takeda Pharmaceutical International AG
    Chair
  • 1130 – 1140
    Workshop Closing Remarks
    Wolfgang Winter
    Director, Informatics Platform R&D
    Agilent Technologies R&D Mktg GmbH & Co KG
    Chair
  • 1140 – 1230
    ISPE Networking Coffee Talk

    This face-to-face forum gives you the chance to have 1:1 conversations in small groups via video chat. Connect with attendees and engage with the speakers about their topics during this networking break.


Speakers

Josef Trapl
Head of MSci Innovation, GMS / Manufacturing Science
Takeda Pharmaceutical International AG
Chair
Wolfgang Winter
Director, Informatics Platform R&D
Agilent Technologies R&D Mktg GmbH & Co KG
Chair
Anton Granget
Managing Director
TechPivot GmbH
Kim Hewson
Engineering Automation Solutions Director
GSK
Rod Hoffman
Lead Manufacturing Business Analyst
AstraZeneca
Martin Mayer
Business Development Smart Engineering Services & Digitalization
ZETA GmbH
Giuseppe Menin
Industry Manager Pharmaceutical
Ing. Punzenberger COPA DATA GmbH
Christian Schoemer
Senior Manager | Technology Strategy & Transformation
Deloitte Consulting GmbH
Henrik Stellmann
Senior Product Manager Integration
Körber Pharma Software
Christian Wölbeling, MD
Executive Industry Advisor
Körber Pharma Software

ISPE Expert Xchange Rates

ON DEMAND ACCESS FOR 90 DAYS

Member $199
Nonmember   $249 
Student* $75

Closed

*ISPE Membership is required for these registration rates.


Group Discount Rate

Bring your team to the ISPE Expert Xchange: Enabling Pharma 4.0™ through Plug & Produce

  • 3 - 5 participants - Save 10%
  • 6 or more - Save 15%

Group discount applies to Member and Nonmember rate only. To qualify, all registrant information must be submitted at the same time. Discounts cannot be combined with other offers. To register as a group, please contact Member Services for more details.


Receive ISPE Expert Xchange Notifications

ISPE Membership Benefits

Become a member today

Gain the knowledge and competitive edge you need to succeed in the pharmaceutical and biopharmaceutical engineering industries and join more than 18,000 pharma professionals from around the world by becoming an ISPE Member.

Benefits include:

  • Online access to select ISPE Good Practice Guides that will help you learn how to practically implement best practices and principles
  • Member-only discounts on Guidance Documents, Conferences, and Training
  • Pharmaceutical Engineering® magazine
  • Communities of Practice access to pharma professionals in specific topics from around the world
  • And more
Join Today   

Stay up-to-date on registration, expert Xchange opportunities, and more by signing up to receive notifications.

Name
Company Type