In today’s fast-changing, highly complex and competitive world, getting first-hand knowledge on future drivers and challenges of the industry or knowing developments in building the factory of the future can help manufacturers to stay ahead of the game. Exyte provided powerful insight in a high-quality roadshow.
“A number of experts shared insights on market direction and growth including future production methods as well as best practices on smart facilities of the GMP regulated industry,” Francois Abiven, President global Business Unit LSC, explains.
Distinguished speakers outline macro trends such as digitization, growing and ageing population and implications such as changed illness patterns, altered consumer behavior and new products or services i.e. cell and gene therapy, biosimilars or personalized medicine. There is not only a demand in new facilities but also in frequent refurbishment that increasingly drives investments. At the same time the constant need for optimization at reasonable cost arises for debate.
⇒ Video: A look ahead in life sciences: Biopharmaceutical 2100 - The future is today (Prof. Dr. Christoph Herwig)
There are various opportunities to meet the challenges in terms of quality, costs and time.
State-of-the art technology for smart facilities
Lean, clean, green, and fast – these are the future needs of a smart fab. The smart fab concept utilizes developments in IoT technology, interconnected IT systems, and automated analytics of data available from sensors, images or other devices in a semiconductor wafer fab. The Digital Twin is a core element of the Smart Fab concept consisting of a virtual digital model of the buildings and all facility systems. Integrated data science along the value chains puts data in a context, ensures data integrity and allows a scalable approach due to standardized real time architecture. Artificial Intelligence helps in understanding data: to perfectly match systems and subsystems, keep the resources the total energy and resources required to run the plant over its entire lifecycle, in the end that operations are as optimized and cost-efficient as possible.
⇒ Video: Pharma and nutrition markets: Accelerating growth in pharma and clinical nutrition markets (Dr. Frank Wartenberg)
Highly flexible, modular plant design
Manufacturers deal with increased pressure to reduce costs and as new therapeutic technologies expand into personalized medicine. How to make large-scale production run as smoothly and cheaply as possible with the market’s existing technology is top of mind in the pharmaceutical industry. In the near future, flexible and fast GMP plants need to go through a shift from prefabricated facility modules to standard construction cells. Long engineering and construction times will be shortened with advanced solutions - predictable and consistent across all geographies. Process steps will be scalable: designed once and built often, enabling high-tech projects even in low-skilled labor areas, giving cost certainty through standard building blocks. Dreamy future or reality?
In order to ensure clients’ cost certainty the starting point must always be the process equipment layout, not the module “box”. “One of the biggest challenges for manufacturers is that they don’t know yet what the rate of production will be, or what technology they’ll need to produce their medicine,” says Stefan Kappeler, Technology Manager Life Sciences at Exyte. Designed with the processes – and not with a box in box design - also the retro-fit of existing real estate assets and vendor independent equipment is possible. “Companies want to make sure they have the best process laid out when they then need to stay competitive.” The solution is 'cellular design': Cellular design bricks (ExyCells) combined with standard clean room systems are basic for phased construction and scalable production. Facility design will adapt to the customer’s unique features and technologies and easily fit into the spaces within the cells. “Exyte enables clients with a new standard approach for fabs: pre-engineered, pre-documented and pre-qualified. Our open ballroom concept with cells allows standard arrangements that can be assembled in different ways for virtually any layout,” sums up Luca Mussati, Vice President of Pharma and Biotech at Exyte.
⇒ Video: Flexible and fast GMP plants: From prefabricated facility modules to standard construction cells (Luca Mussati)
⇒ Video: The importance of a manufacturing platform approach: Ballroom manufacturing in cell and gene therapy (Dr. Oliver Bartelsen)
Improved project management
Working in this new environment designers, engineers and project managers can skip the ‘conceptioneering’ phase upfront to projects (30-50% of a project) and shorten the time to market. The design concept goes hand in hand with a holistic control strategy over life cycle, continuous integrated processing and quality control in projects. In addition to the above described special modularity, also a functional modularity regarding the involved crafts contributes to more automated and standardized, hence efficient plants.
Without doubt, numerous benefits in fast-track, high-tech, lean projects will convince prospects and clients, most important: immediate lay out and cost indication as well as single source responsibility result in CapEx and OpEx reduction.
⇒ Video: Bio-Pharmaceutical: Location strategy in a dynamic market (Woody Hydrick)
It is not only about speeding up the project delivery and reducing unproductive deployed capital but also about higher velocity in project delivery. Critical to clients’ business models is that their facilities will be more flexible and more adaptable as products come through clinical trials and global market forecasts become refined. Key success criteria for a commercially viable product will be guaranteed automatically in this process.
⇒ Video: Panel discussion: Managing cost of goods and speed-to-market with modern GMP facilities (all)
This is your benefit in a strong committed partnership with the thought leader Exyte always having clients’ needs in mind!