Joeri Van Wijngaarden

R&D Engineer

Aizon

Digital maturity and the road to Pharma 4.0 requires a digital transformation of information systems, internal resources and manufacturing processes. Together these create holistic value networks of interconnected systems across the enterprise, and artificial intelligence (AI) is a tool that shines under these conditions. In this talk I would like to go over a value proposition of AI for biotech and drug manufacturing with a patient-centric approach that focuses on quality and control. I'll discuss several applied use-cases for AI across the product's life cycle that impact how we can better manufacture pharmaceutical products. AI-driven manufacturing and drug-discovery help us understand the complex reality of process variability and enable more efficient processes operating under better control.

Nadin Osman

Quality Manager

Oxyphen GmbH Filtration Group

Prudence Edwards

Operational Excellence Specialist

Thermo Fisher Scientific Brisbane, Australia

Digitalisation’s potential to increase productivity and profitability is widely acknowledged, yet the journey towards a fully digitalised process can be a daunting one. This is especially the case for production plants on the lower end of the digital maturity scale. Therefore, to open the Pharma 4.0 Roadmap for Implementation track, the winning solution from the 2021 ISPE Student & Recent Graduate International Hackathon will be presented, providing a highly practical and innovative example of how to commence the digitalisation journey by capitalising on current infrastructure and resources.

The 2021 ISPE Hackathon, with a problem statement provided by Bayer, required participants to propose a lean solution to convert paper-based batch record documentation into a digital, readable format, without relying on retrospective digitalisation. Strict constraints were also imposed, including covid restrictions, budget limitations and committed production volumes, hence eliminating solutions that would require a production shutdown. This presentation will also explain the priority areas for digitalisation identified in the solution, using the example of an OSD production process for contextualisation. This is then further developed into a comprehensive, high-level digitalisation roadmap, highlighting all the advantages of a fully digitalised process. The roadmap includes an implementation plan based on the principles of agile development, budget estimation, GMP and data integrity assessment, and review of technology requirements.

Svenja Michaela Gutsche, PhD

Head of Aseptic Production STE-1

Bayer AG

Petra Merker

Biological Quality Control Expert

Bayer AG

One of the most critical and challenging operations within the Pharmaceutical Industry is the aseptic fill/finish operation of sterile products. The use of robotics in this area enhances prevention of contamination and will benefit flexibility, fast turn over, scalability from development to commercial and digitalization. In parallel to the development of smart robotic filling solutions, the need for modern, alternative viable monitoring methods like BFPCs (Biofluorescent Particle Counters) arises. Especially for closed robotic isolators with minimum human interventions or even completely gloveless, BFPCs are of great advantage compared to conventional monitoring methods by continuous, real-time monitoring and significantly minimizing particle generation and contamination risks. Looking back a few years we started talking about robotics and gloveless isolators. It was mostly based on smaller and innovating companies who saw the benefit and realized where Industry needed to go. Most of the well-known manufacturers weren’t in the position to believe in this trend. The Landscape has totally changed and with more and more companies going the route of smaller, personalized and CGT batches we as Pharmaceutical Manufacturers and in particular the patients will benefit greatly.

Thomas Lee Johnson

CEO & Founder

Agile Immersive

• A. The neuroscience of unconscious behavior and why starting with cultural transformation is crucial
  1. Learning / Unlearning healthy thinking vs unhealthy thinking
  2. Human Reactions: Survival to Harmony to Overcoming
  3. Reaction: moving teams from Medulla Oblongata to Frontal Lobe
  4. The neuroscience of leadership: hunter-gatherer to hyper specialization
• B. How does aligning on a shared purpose turn individuals into a team?
  1. Meaningful work makes meaningful moments makes authentic teams
  2. Distill mission statements into purpose statements that teams execute daily
  3. Prioritize like you mean it. There is only one number one priority.
• C. The Insider's Guide: Top 20 Behaviors that indicate Pharma 4.0 success