Agenda
Our education program offers cutting-edge technical sessions, shedding light on the latest advancements in the pharma industry.
All session times are listed in Central European Summer Time (CEST). Find your personal viewing time on the World Clock.
Filters
Selected filters:
-
Pharma 4.0 Interconnected Facility Design and Construction
Tue, 10 Dec
1330 – 1400
Pharma 4.0 Interconnected Facility Design and Construction
Alan Bateman, Johnson & Johnson Innovative Medicines
Planning for the Future with Pharma 4.0 in a Greenfield Project.
In my presentation, I will emphasize the importance of designing a smart manufacturing facility with interconnectivity in mind, keeping an eye on the future. I will share practical tools, processes, and approaches to ensure that our facilities are equipped with the latest capabilities and, be as foreseeably well-prepared for the evolving needs of the industry into the next decade. Attendees can expect to gain valuable insights on how to navigate the complexities of designing for the future. I will highlight some key factors such as benchmarking, leveraging guidance resources, and adopting maturity models. By the end of the presentation, attendees will have a clearer understanding of how to approach smart manufacturing facility design and be equipped with useful takeaways to drive their own projects forward.
1400 – 1430
Pharma 4.0 Interconnected Facility Design and Construction
Charles Heise, FUJIFILM Diosynth Biotechnologies Ltd
The future biomanufacturing facility is envisioned as a fully autonomous, continuous operation. Despite common use in other industries, biomanufacturing is yet to adopt this. Barriers include technical, operational, cultural, and regulatory issues. A cross-industry team is working towards this goal, having identified over 100 gaps in continuous downstream bioprocessing. They’ve created a risk assessment blueprint, simplified control at the unit operation level, and are working on a roadmap for autonomous bioprocess control. By addressing key areas like risk assessment and control/connectivity, we’re progressing towards flexible, resilient, and sustainable biomanufacturing facilities with the ultimate goal of achieving lights out manufacturing.
1430 – 1500
Pharma 4.0 Interconnected Facility Design and Construction
Christina Stern, Takeda Austria GmbH
Martin Raab, Takeda Austria GmbH
Bridging Innovation and Compliance: Covering Pharma 4.0 Technologies and Annex 1.
The presentation focuses on the intersection between Annex 1 and Pharma 4.0, with a specific emphasis on the innovative Takeda Linz beePFS project. It will begin with an introduction to Takeda and its Linz production site, highlighting the company's values and unique beehive culture. The overview will explain how these values influence the beePFS project, a high-speed initiative aimed at implementing a prefilled syringe filling line to reduce process performance qualification time to 24 months, while incorporating aspects of Pharma 4.0 and updated Annex 1 guidelines.
The objective of the beePFS project is to enhance syringe supply security with a dual-source strategy, enabling larger quantities to be supplied quickly and adding in-house syringe filling capabilities to Takeda's aseptic network. The presentation will explore how the updates to Annex 1 and Pharma 4.0 principles impact pharmaceutical manufacturing, showcasing the transformative potential of the beePFS project as a pioneering innovation in the industry. It will address the challenges of integrating new requirements and technologies, the decision-making process for technology selection, and how Takeda leveraged the concept of Pharma 4.0 to ensure a lean, compliant production process within a fast-tracked project timeline.
1545 – 1610
Pharma 4.0 Interconnected Facility Design and Construction
Simon Webb, Liminos
Simon Capewell, AstraZeneca
A practical approach to developing a vision, strategy, design, construction, and operationalizing a greenfield Pharma 4.0 manufacturing facility. A case study of the new AstraZeneca continuous API commercialization facility currently being built in Dublin will be showcased. This will cover technology and data, but also the importance of process redesign and the people change required.
1610 – 1635
Pharma 4.0 Interconnected Facility Design and Construction
Guido Kremer-van Der Kamp, Merck Chemicals GmbH
Since the definition of ballroom concept was first introduced in 2013 via ISPE’s Baseline Guide: Volume 6 – Biopharmaceutical Manufacturing Facilities, the industry has looked for opportunities to further build in flexibility for bioprocessing and biomanufacturing into facility design. At the same time, as an industry we are also being challenged on our pace of adoption of industry 4.0 principles, with pharma and life sciences behind the curve compared to other major manufacturing industry segments. This presentation will address: the journey of the industry to ballroom concepts; the current (and known future) industry challenges when aiming for a fully connected digital plant; and the considerations to take when designing for an interconnected facility that retains the flexibility of open ballroom concepts, with reference to recent BioPhorum publications and initiatives (including closed systems, modular and mobile design via plug and play, and facility-and process-level digital twins) as well as other industry standards and consortia works.
1635 – 1700
Pharma 4.0 Interconnected Facility Design and Construction
Dominik Rabus, PhD, RABUS.TECH
Supply Chain Solution via Cloud-Based Analytics and NIR-Scanners.
To accelerate the local detection of falsified medicines and strengthen the integrity of
pharmaceutical supply chains, a cloud based analytical drug screening solution has
been developed. The backbone of the solution is a secure, cloud-based database
containing details of the composition of medicines. Data science and AI have been
used to build prediction models to capture the manufacturing variability of solid drugs of
a given pharmaceutical company produced in different dosages, raw materials, and
locations. In the field, a drug sample can be authenticated using a mobile analytical
drug screening device containing a spectral sensor that transmits and within seconds
receives the results utilizing the database via a smartphone app. The solution allows in
principle anybody to verify a sample’s authenticity within minutes.
Until now, suspect drugs have typically been shipped to a central QC laboratory which can take several weeks for obtaining the final result due to delays in transportation, customs, etc. The presented solution has cut the authentication time to a matter of days. This helps our pharmaceutical partners work with local health and law enforcement authorities to combat the worldwide threat to public health represented by falsified medicines.
Hear From Top Industry Thought Leaders on the Challenges and Solutions Impacting the Pharmaceutical Industry
Speaker Qualifications
Speakers selected to present at ISPE events are leading professionals in their fields. However, it may be necessary to make substitutions. Every possible effort will be made to substitute a speaker with comparable qualifications. Every precaution is taken to ensure accuracy. ISPE does not assume responsibility for information distributed or contained in these events, or for any opinion expressed.
Agenda Changes
Agenda is subject to change. Last minute changes due to functional, private, or organizational needs may be necessary. The event organizer accepts no liability for any additional costs caused by a change of the agenda.