How Modularization and Digital Delivery are Transforming Pharma Manufacturing
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BioPharm InternationalBioPharm International, Manufacturing and Facilities eBook November 2024
Volume 37
Issue 4
Pages: 14–16
Modular and replication strategies are being utilized to meet growing demand for CDMO facilities.
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Global spending on pharmaceuticals and biotech therapies is forecast to reach US$2.3 trillion by 2028 amid growing demand and an aging population (1). In response, the life sciences industry is partnering with contract development and manufacturing organizations (CDMOs) to meet this challenge.
To deliver potentially life-changing therapies to patients faster, biopharma companies are leveraging CDMOs’ capabilities to rapidly expand manufacturing capacity, utilizing novel modular and replication strategies. The industry is also drawing on CDMOs’ ability to leverage their regulatory landscape expertise to ensure that lifesaving therapies are delivered to the patient on time and on budget.
Growth in the CDMO sector
Biopharma companies partner with CDMOs to handle commercialization, enabling the biopharma companies to efficiently manage their pipelines and focus on their core priorities, namely innovating new medicines. In response to growing outsourcing demand from biopharma companies, the CDMO sector is also growing. Since 2020, industry estimates point to a 20% increase globally in the number of CDMO facilities that are manufacturing clinical- or commercial-scale biologics (2).
To provide greater manufacturing capacity in a growth environment, the increase in new facilities is set to continue. As CDMOs look to deliver new facilities in diverse geographical locations in a fast, risk-free manner, cutting-edge technology, combined with innovative execution strategies, can play a central role in realizing these ambitions.
The modular mindset
Industry best practice in CDMO project delivery centers on digital replication and cloning. The use of digital tools and standardized platforms allows CDMOs to realize the full potential of the “design one, build many” philosophy, enabling them to deliver an “ecosystem” of facilities across multiple sites.
Digital replication ensures that CDMOs can quickly increase capacity and support the speedy manufacturing ramp-up that biopharma companies require. The underlying strategy at the heart of this digital approach is modularity, mitigating risk while also reducing costs and making timelines shorter. Ultimately, the modular approach supports the increased production of potentially life-saving treatments and therapies.
From a design perspective, modularity breaks down a scope into standard modules that can be connected in a customized way. Modularity also provides a methodology for standardized factory design that allows solutions providers to build identical facilities, irrespective of the location.
At the heart of the modular approach is the use of standardized components in design and construction. The more repetitive the use of standardized components, the more modular the facility becomes, allowing for reduced customization and complexity and greater flexibility. As the CDMO sector continues to grow in support of demand from biopharma clients, the need to buy into the modular philosophy is vital.
This project technique is delivering CDMO facilities—and whole “ecosystems”—that can adapt to changes in a structured way. And as the biopharma sector continues to innovate and bring new treatments and therapies to market, modularization provides the necessary flexibility, scalability, and adaptability to support such rapid shifts.
Facilities designed using a modularized approach can be easily adapted to accommodate changing production volumes, ensuring that their size and capacity align with market demands without the need for extensive modifications.
Read the article in the Manufacturing and Facilities November 2024 eBook.
About the authors
Jordan Ulrich is vice president, Project Delivery, FUJIFILM Diosynth Biotechnologies, and Dana Tilley is vice president and general manager, Life Sciences North America, Jacobs.
Article details
BioPharm International®
eBook: Manufacturing and Facilities
November 2024
Pages: 14–16
Citation
When referring to this article, please cite it as Ulrich, J and Tilley, D. How Modularization and Digital Delivery are Transforming Pharma Manufacturing. BioPharm International Manufacturing and Facilities eBook. 2024 November.
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