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 Pacific Time (PT). Find your personal viewing time on the World Clock.
Filters
- Focusing on using single-use technologies in bioprocessing.
- Discuss concerns on sustainability based on plastic waste streams.
- Review the scale of plastic waste produced
- Review a bioprocess modeling package that can estimate the plastic usage for typical monoclonal antibody production at varying scales
- Discuss fluid handling components, filters, and resins.
- Show worldwide monoclonal antibody estimated total annual tons per year for bioprocess-related plastic waste generated by the industry.
- Inform sustainable practices within the biopharmaceutical industry and encourage the development of more sustainable disposable technologies.
Since adopting single-use technologies in biopharmaceutical manufacturing in the 1990s, there has been concern about the generated plastic waste streams. Estimates for plastic waste based on production quantities provide the biopharmaceutical industry with methods to predict waste produced and establish more sustainable disposal methods as single-use technology products expand into the mainstream production of biologics.
The pharmaceutical sector is in a state of constant development, currently focusing on creating and building facilities that can support a flexible array of products (in terms of variety, quantities, and sizes). Additionally, there is a growing interest among some stakeholders to manage the entire process from clinical to commercial stages, including full lifecycle products, within a single location, as well as the co-location of different product modalities. These trends indicate a requirement for facilities that are more adaptable, enabling manufacturing operations to be quickly relocated, retrofitted, or expanded with efficiency. This adaptability not only enhances operational efficiency but also allows companies to respond swiftly to market demands and regulatory changes, ultimately fostering innovation and reducing time-to-market for new therapies.
Bristol Myers Squibb aimed to establish a global standard for a new flexible manufacturing concept that would facilitate multi-modality manufacturing across different products, volumes, and scales, while also enhancing future capacity decisions and regulatory adaptability. BMS collaborated with PM Group to create a standardized design that would separate the Building Shell from the interior layout, allowing for rapid deployment at both existing and new locations globally. In line with the design approach, the team aimed to standardize technology platforms and shift away from "purpose-built" designs to develop generic Process Modality floorplates (modules). The team leveraged a significant portion of BMS’s current product pipeline as a benchmark to appropriately size process capabilities and technologies that would be included in Flex Modules. These modules were then designed to meet Launch capabilities and be versatile enough to expand and accommodate Commercial capacities in the future.
This nimble strategy will allow BMS to build globally adaptable shell structures within their network, irrespective of product choices. This will enable swifter market entry while also allowing ease of future repurposing. This presentation summarizes the design methodology employed to bring this innovative Agile Manufacturing Concept to fruition.
The pharmaceutical industry is facing a multitude of external challenges, including cost pressures from healthcare systems, such as the Inflation Reduction Act (IRA), patent cliffs, and changes in the global political landscape, exemplified by the BioSecure Act. Amidst these challenges, Pharma 4.0 is emerging as one of the paths to sustainably bringing innovation to patients. The ISPE's frameworks have supported and encouraged steps towards digitalization and outlined benefits and use cases. However, the pharma industry has been slow to change compared to other sectors. Already in 2021, the FDA was stating that "some industries are now well into Industry 3.0, but in many ways the pharmaceutical industry is still very much transitioning into it." With two-thirds of drug shortages historically still attributed to quality-related issues, the opportunities to continue the digitalization journey are plentiful.
Exploring the root causes, many companies are lost on the journey, either organizationally or technologically, with some unsure of where to start, others pursuing multiple pilot projects, and some finding that the technology journey is just the beginning of the transformation journey. Additionally, the industry faces a tension between decentralized, democratic, and duplicative organizing principles versus centralized, cumbersome kingdoms.
Takeda has been on this journey for many years and has taken the challenges head-on. From the Facility of the Year (FOYA) awards for Singen and Linz awards in 2022 and 2024 to public commitments to sustainability Pharma 4.0, Takeda's approach has enabled the implementation of numerous technologies and new ways of working. As the industry faces an increasingly diverse portfolio and an ever-complex manufacturing landscape, Pharma 4.0 will be a key driver of growth to meet patients’ demands. We would like to explore some of the good practices we learned on our digital transformation journey.
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.