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2022 ISPE Pharma 4.0™ Emerging Leader Hackathon

December 5, 2022@7:30 am-December 6, 2022@6:00 pm


The Hackathon is a regular event organized for ISPE Emerging Leaders and Students taking place at major ISPE Events. The main objective of a Hackathon is to explore novel solutions, build knowledge and an innovative culture aligned with trending topics in the pharmaceutical industry. Furthermore, it promotes networking between emerging leaders, academics and senior industry experts. A Hackathon usually lasts over the course of two days. Participants get together in groups and work on specific problems. During the intensive sessions they are supported by coaches. The innovative outcomes and potential technical solutions are finalized and presented on the second day. A jury evaluates the results, provides feedback and awards the team with the best solution.


This Hackathon’s topic will be

“A hands on Pharma 4.0 blueprint manufacturing exercise where digital and quality matters”.

A close cooperation between the ISPE Emerging Leaders and the ISPE Pharma 4.0™ Working Group Plug & Produce ensures a hands-on and live experience by working with a real cell-line process. The several different work streams are driven by priorities in the manufacturing and business environment. Each work steam is supported by several selected industry partners. The Hackathon aims to develop a manufacturing blueprint considering the needs and possibilities of Pharma 4.0™.

The planned workstream are:





WS 1

System and Data Architecture (IT/OT)

●    Scalable, modular and phase appropriate data architecture: data flows from sensor to manufacturing network to secured IoT cloud solution

●   Consideration for data integration and data quality

●    Integration of sensors to comply with plug and produce

●    Establishment of bi-directional communication between sensors and information system


WS 2

Operations and workflows (Manufacturing and Analytics)

●    Revise standard operating procedures from static to dynamic approach

●    Design automated workflows for batch monitoring, and real-time release (e.g. release by exception)

●    Using No-Code and Low-Code Platform to implement digital workflows and EBR data collection (Data created by workstream 3 via OPC UA)

●    Control recipe and batch record optimization – where to automate and where not

●    Stepwise implementation from classical eBR to dynamic recipe management


WS 3

Shopfloor integration (Sensors and Equipment)

●    Identification of optimal data standards for sensors and equipment to enable plug and produce

●    Design of structure for universal data availability and connectivity of IoT devices

●    Using Siemens Integration Platform to establish OPC UA Connectivity to Equipment

●    MSI Interface connection (message-based communication)

●    Admin shell framework and concept


WS 4

Quality and validation

●    Validation strategy – beyond classical CSV (Concept and Sample implementation for computer system assurance to self-validating systems(?)) 

●    Design and establishment novel workflows for (real-time) e-validation & risk assessment of process (CSA)

●    Closed loop optimization framework aligned with the future quality requirements and regulatory needs within the business environment (real-time-release and process change)


WS 5

Simulation and Data analytics

●    Simulation of end-to-end quality and manufacturing outputs (for prediction of certificate of analysis)

●    Evaluate sophisticated modeling approaches using sensor live data and mechanistic process models for prediction of final product parameters – yield & COGS & sustainability

●    LES laboratory execution system feed with information àvirtual certificate of analysis

●    Process & analyze data out of the different work-streams

●    Visualization of real-time collected data


*The Workstreams are supported by several companies: Applied Materials, Biopharm Services, COPA-DATA, DataHow, Endress+Hauser, FrontWell, Tulip, Hamilton, Sartorius and Siemens”

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December 5, 2022@7:30 am
December 6, 2022@6:00 pm


Uferstrasse 15
Orth an der Donau, 2304 Austria
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