Industria Farmaceutica

2020 ISPE Facility of the Year Awards Winners Announced

Facility of the Year Awards (FOYA) is the premier global awards program of ISPE recognizing innovation and creativity in manufacturing facilities serving the regulated healthcare industry. The award-winning projects selected by the FOYA program set the standard for pharmaceutical facilities of the future,

The International Society for Pharmaceutical Engineering (ISPE) announced the 2020 Facility of the Year Awards (FOYA) Category Winners – including two winners of the inaugural Social Impact Category Award. Awardees include:

  • Hoffmann-La Roche Ltd (Equipment Innovation)
  • Pfizer, Inc. (Facility Integration)
  • Sanofi (Facility of the Future)
  • Eli Lilly and Company (Operational Excellence)
  • Janssen Pharmaceuticals (Process Innovation)
  • Bristol-Myers Squibb (Project Execution)
  • GlaxoSmithKline (Social Impact)
  • United Therapeutics (Social Impact)

The FOYA’s judges’ panel has also awarded Honorable Mentions to:

  • Boehringer Ingelheim Biopharmaceuticals China Ltd.
  • Janssen Pharmaceutical Companies of Johnson & Johnson and Legend Biotech USA Inc.

ISPE has developed the Facility of the Year Awards program to recognize the best newer renovated Pharmaceutical and Biotechnology manufacturing facilities that combine all aspects of the building into a superior working environment. The Judges Team consisting of prominent industry leaders with extensive global experience choose category winners and the overall Facility of the Year Award winner. The members of the FOYA committee represent a global cross-section of the pharmaceutical industry, as well as staff members from program co-sponsors ISPE.

“Technology and innovation in the pharmaceutical industry are more critical now than ever before as healthcare worldwide is straining from the COVID-19 pandemic,” said Tim Howard, PE, CPIP, President and CEO, ISPE. “Even in these trying times, it is important to spotlight the dedication of companies like the 2020 FOYA Category Winners who are at the forefront of not only setting the standard for pharmaceutical facilities of the future but also creating new opportunities to enhance patient health and safety worldwide.”

Antonio (Tony) Crincoli, PE is Senior Director and Head of Global Supply, Global Technology & Engineering at Upjohn (division of Pfizer), currently chairs the ISPE Governance Committee and Facility of the Year (FOYA) Judging Team. We asked some questions to him.

How were the ISPE Facility of the Year Awards (FOYA) born? What is the idea behind them?

FOYA awards were started in 2005. They were intended to share significant efforts, highlight and reward innovation and creativity in facility design, construction, and operations in the biopharmaceutical manufacturing industry. With ISPE’s membership being the leading players in the industry, it was well positioned to leverage their collective knowledge and experience and share their successful efforts. The FOYA program has grown significantly in the past 15 years, where it is now recognized as the leading biopharmaceutical industry award program, with over 86 winners from 19 countries.

 

Which are the characteristics of a project that obtains such a prestigious award?

One word…innovation. Some think that only large projects get considered, but more often we see and reward small projects that have a huge impact in implementing new technologies, efficiencies in manufacturing, insuring quality, or service and access to the patient. We have seen clever process improvements, efficiencies, sustainability & green chemistry, quality by design initiatives in manufacturing, integrated automation technologies, implementation of new supply chain improvements, deliberate efforts at bringing medicines to underserved patient groups.

 

How is it composed the group that judges the various projects?

Judges are a very diverse, experienced and talented group of professionals from throughout the biopharma world. They have backgrounds in biopharmaceutical engineering, manufacturing, supply chain, quality, and development with a keen understanding to recognize innovation in delivering safe and effective medicines to patients.

It’s important to maintain a balance between scientists, engineer, manufacturing and supply, as well as geographical perspective from throughout the world including North/South America, Europe, Asia.

 

How do you evaluate the various projects within ISPE?

We ask a few basic questions:

  • What innovation does this project bring to the industry?
  • Does this project bring cutting edge technology, establish new benchmark standards, or does it implement existing technologies in a clever way?
  • What is the impact to the patient? Does the patient benefit from better quality, safety, cost, or accessibility to medicines?

It’s important to mention that we see many very creative and substantial project submissions, and often it is difficult to narrow awards to a small list.

 

How have projects changed from the technological point over the years?

Originally projects focused on project execution, facility construction, design and standalone new technology. The shift has been to the entire drug delivery process. This includes process development, automation and technology integration, integrated quality design, manufacturing, supply chain improvement and service to the patient, and projects targeted at serving patient groups with unmet medical needs.

 

Why are the Facility of the Year Awards so important for the entire pharmaceutical community?

As an industry, we have an obligation to insuring the highest quality, safety, and accessibility of medicines to our patients. It is even more important these days to recognize and share innovation among the membership. Sharing and recognition helps drive the next generation of innovation.

 

2020 Facility of the Year Category Awards Winners

The Equipment Innovation Category was awarded to F. Hoffmann-La Roche Ltd for its New In-Vivo Building in Basel, Switzerland. This project brings innovation to one of the lesser understood parts of the pharmaceutical discovery and development process – the animal research facility. The equipment innovation that is found in every part of the project aims to protect researchers and animals, drive efficiency, and set new industry standards for animal research. 

The Facility Integration Category was awarded to Pfizer Inc. for its Pfizer Building E – Andover Clinical Manufacturing Facility (ACMF) in Andover, Massachusetts, USA. The ACMF proves that a sustainable, flexible, configurable, and wireless clinical manufacturing facility can achieve complete integration into a dynamic, high-performance process development flow today and preserve that integration no matter how biologic drug development may evolve in years to come.

Sanofi was awarded the Facility of the Future Category Award for its Sanofi Digitally Enabled Integrated Continuous Biomanufacturing Facility in Framingham, Massachusetts, USA. This fully integrated bioprocessing facility takes the application of disposable process technology and flexible facility design to a new level. Using the best of already proven technology and design, they’ve expanded the use to allow design and construction of a facility that enables continuous upstream and downstream processing.

Eli Lilly and Co. won the Operational Excellence Category Award for its Innovation Development Center (The Center) in Indianapolis, Indiana, USA. They embraced optimized work processes and provided workspace to agilely adapt not only to laboratory needs, but to the most appropriate processes for collaboration and workspaces. The Center established itself as a model for rapid pharmaceutical development, proving to the industry that it is possible to bring successful therapies to market faster than ever before.

Janssen Pharmaceuticals won the Process Innovation Award Category for its Mirror-1: The Continuous Manufacturing Platform for the Development of a new Oral Solid Dosage Portfolio based in Beerse, Belgium. Mirror 1 incorporates and integrates three different process technologies (direct compression, roller compaction, and twin-screw wet granulation) into a single equipment set. This required intense collaboration with multiple equipment vendors, but ultimately enables this one platform to respond to the needs of the Janssen’s entire solid dosage portfolio.

Bristol-Myers Squibb is the winner of the Project Execution Category Award for its Multi-Product Cell Culture (MPCC) Project in Cruiserath, County Dublin, Ireland. The goal of the Project was to transform an existing BMS Active Pharmaceutical Ingredient (API) site into a state-of-the-art Biologics Drug Substance Manufacturing Campus that includes consideration for future commercial products.

The first of two companies to be awarded in the Social Impact Category was GlaxoSmithKline for its Attachment Inhibitor (AI) Project based in Parma, Italy. The project needed to be exceptionally fast to ensure continuity of supply of fostemsavir to allow submission of a new drug application to the FDA in December 2019. The result was 15 months from ground-breaking to handover of the fully finished facility to start manufacture.

The second of two companies to be awarded in the Social Impact Category was United Therapeutics for its Dinutuximab-Dedicated Oncology Medical and Analytical Laboratory in Silver Spring, Maryland, USA. The judging team was especially impressed by the sheer number of challenges this project had to overcome, while never losing focus on why they were doing this work. The project also took the time to consider the impacts to the community both during and after construction, even including external artwork for the facility. 

Boehringer Ingelheim Biopharmaceuticals China Ltd. was awarded an Honorable Mention for its new facility in Shanghai, China which is the first international provider of biopharmaceutical contract manufacturing solutions to clients in China. The commercial facility OASIS is designed to fulfill a maximum degree of flexibility: this includes a modular approach to fit out distinct manufacturing modules sequentially, implementing a single-use bioreactor design to react to various customer needs until the mode of operation. 

Janssen Pharmaceutical Companies of Johnson & Johnson and Legend Biotech USA Inc. received an Honorable Mention for its Raritan CAR-T Clinical Manufacturing Facility in Raritan, New Jersey, USA. Janssen entered into a worldwide collaboration and license agreement with Legend Biotech to jointly develop and commercialize a therapy for multiple myeloma, an incurable blood cancer that occurs when malignant plasma cells grow uncontrollably in the bone marrow.

The 2020 FOYA Category Winners will be formally recognized at the ISPE Facility of the Year Awards Banquet and Dinner on 1st November 2020, in Philadelphia, Pennsylvania USA. Held in conjunction with the 2020 ISPE Annual Meeting & Expo, the banquet will feature acceptance speeches from the FOYA recipients and presentations from noted industry leaders. The 2020 FOYA Overall Winner will be announced at the conference during the Membership and Awards Breakfast.

 

About ISPE

The International Society for Pharmaceutical Engineering (ISPE) is the world’s largest not-for-profit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle. The 18,500 members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical delivery devices in more than 90 countries around the world.

Founded in 1980, ISPE has its worldwide headquarters and training center in North Bethesda, Maryland USA, and its operations center in Tampa, Florida USA. Visit ISPE.org for more

 

ISPE.org/FOYA

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