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July / August 2024

Introducing the 2024 ISPE FOYA Submission Finalists

ISPE
Introducing the 2024 ISPE FOYA Submission Finalists

Each year, ISPE recognizes innovation in pharmaceutical facilities with the Facility of the Year Awards (FOYA). The 2024 FOYA submission finalists were announced at the 2024 ISPE Aseptic Conference in Vienna, Austria. Finalists for the 2024 awards highlight the continued progress and innovation at play in pharmaceutical manufacturing worldwide and across modalities. From projects tailored to the delivery of novel therapeutics to facilities focused on pushing the limits of speed and efficiency, one common thread is the focus on delivering life-changing therapies to patients in need.

FOYA is the premier global awards program recognizing innovation and creativity in manufacturing facilities that serves the regulated healthcare industry. The award-winning projects selected by the FOYA program demonstrate excellence in facility design, construction, and operations, setting the standard for pharmaceutical facilities of the future. Winners are recognized across the categories of Innovation, Operations, Supply Chain, Pharma 4.0™, and Social Impact.  

“The announcement of ISPE’s FOYA submission finalists is step one to recognizing and celebrating innovation in pharmaceutical manufacturing plant design and qualification,” said Thomas Hartman, President and CEO, ISPE. “These facilities, and the people that bring them to life, transform patient lives. Our ultimate priority is to foster novel technologies and processes, accelerating the availability of transformational medicines to patient populations.”

2024 ISPE FOYA SUBMISSION FINALISTS

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Beam Therapeutics

Project: Beam Cell and Gene Therapy Facility
Location: Research Triangle Park, North Carolina, US

Mission: Beam is a value-driven organization committed to its people, cutting-edge science, and a vision of providing lifelong cures to patients suffering from serious diseases. The cell and gene therapy facility is a significant part of this vision and is instrumental in Beam’s commitment to establishing a leading, fully integrated platform for precision genetic medicines.

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Bristol Myers Squibb

Project: Devens Cell Therapy Facility
Location: Devens, Massachusetts, US

Mission: The mission of the Devens cell therapy facility is to design, build, and start a world-class facility that will deliver innovative medicines that help patients prevail over serious diseases.

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Chugai Pharma Manufacturing Co., Ltd.

Project: UK4
Location: Tokyo, Japan

Mission: With the UK4 Project facilities, Chugai aims to rapidly start first-in-human trials in the initial stage of clinical development to achieve early proof of concept in its antibody and other bio-drug projects. The facility will help Chugai expand supply capacity and enhance speed and flexibility. This will accelerate the development of ever-evolving antibody drugs to deliver innovations to patients worldwide. The accelerated development of new products will address unmet patient needs for effective treatments. In addition to patient needs, the UK4 facility was also constructed to contribute to sustainability through environmental goals.

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Eli Lilly Kinsale Limited

Project: IE2b
Location: Kinsale, Ireland

Mission: With the IE2b project, Eli Lilly set out to develop and deliver a first-of-its-kind hybrid peptide manufacturing facility. IE2b was built to support the commercial supply of large-volume, life-changing synthetic peptide molecules. This was done with a combination of traditional solid-phase peptide synthesis technology, new liquid-phase peptide synthesis concepts, continuous processing technology, and digital plant solutions.

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INCOG BioPharma Services

Project: First to Flex
Location: Fishers, Indiana, US

Mission: INCOG set out to build a customer-driven contract development and manufacturing organization (CDMO) focused on providing customers with unparalleled service and products with the highest quality standards.

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Novartis Pharmaceutical Manufacturing GmbH

Project: BioFuture Plant1
Location: Langkampfen, Austria

Mission: A groundbreaking concept brought to life: the innovation in manufacturing drug substances for biologics known as BioFuture Plant1 represents a revolutionary leap forward. BioFuture stands for “Biomanufacturing of the Future.” It is one of the world’s most advanced facilities dedicated to producing therapeutic proteins through continuous and automated process technologies. The adaptable design of the BioFuture facility supports the manufacturing of a diverse range of molecules across a broad product portfolio. Accelerating time to market ensures that lifesaving and life-changing medications are available to more patients sooner. With reduced CO2 emissions, BioFuture is also environmentally friendly.

 

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OrchidPharma LTD

Project: Sterile API Manufacturing Facility (Phase 27)

Location: Tamilnadu, India

Mission: OrchidPharma’s mission is to complete the development of the sterile API manufacturing facility (phase 27) on time, cost-effectively, and in a safe environment, resulting in the production of 50 tons of sterile injectables per year.

 

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Pfizer Asia Pacific Manufacturing Ltd

Project: Pfizer API Facility Extension
Location: Tuas, Singapore

Mission: This project was aimed at accelerating supply through the Pfizer API Facility Extension.

 

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Takeda Austria GmbH

Project: beePFS - Prefilled Syringe Filling
Location: Linz, Austria

Mission: The goal of the beePFS project is to implement a prefilled syringe filling line in Linz for Takeda products. Classified as a “super warp speed” project, it was intended to significantly reduce the time required to achieve process performance qualification in 24 months.

 

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Ultragenyx

Project: Vector Gene Therapy Manufacturing Facility
Location: Bedford, Massachusetts, US

Mission: This project focused on advancing and expediting gene therapy production for rare and ultra-rare diseases with an in-house GMP manufacturing facility (both drug substance and drug product). This will ensure a reliable supply of products for clinical and commercial use.

 

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United Therapeutics Corporation

Project: Lightyear
Location: Research Triangle Park, North Carolina, US

Mission: In anticipation of the expected US FDA approval of Tyvaso DPI—a new formulation and inhalation device for inhaled treprostinil and the only dry powder inhaler approved for use in pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease—United Therapeutics identified the urgent need to expand their warehousing and logistics capabilities to support their growing operations. Not only would this new warehouse and logistics center provide the needed space for continued growth, but it would also deliver critical resiliency for facility and logistical operations. In addition to expanding treatment options and further fortifying the supply chain, the project was carried out with as minimal an impact on the environment as possible.

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Wheeler Bio

Project: The Ziggurat
Location: Oklahoma City, Oklahoma, US

Mission: To accelerate the path from discovery to investigational new drug filing, Wheeler Bio, a new CDMO established in Oklahoma City, set out to build a GMP facility for early clinical phase biologic services. The facility is designed with a risk-based approach, using open ballroom and single-use manufacturing. It is digitally connected and uses a local workforce to sustain the future biomanufacturing ecosystem. Wheeler Bio’s facility and business model allow for a low-cost and accelerated model for translating innovation into clinical impact.

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Zydus Pharmaceuticals Ltd.

Project: Oral Solid Dosage Manufacturing Facility
Location: Gujarat, India

Mission: Adhering to Zydus’s promise of being “dedicated to life” in all its dimensions, this project’s mission is centered on an unwavering commitment to excellence and passion for innovation. It will support implementation of advanced technologies and sustained quality culture, providing affordable and quality medicines globally.

ABOUT THE ISPE FOYA PROGRAM

Established in 2005, the ISPE FOYA program recognizes state-of-the-art projects using new, innovative technologies to improve product quality, reduce the cost of producing high-quality medicines, and demonstrate advances in project delivery. The FOYA program provides a platform for the pharmaceutical science and manufacturing industry to showcase its accomplishments in facility design, construction, and operation while sharing the development of new technology applications and cutting-edge approaches. 

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