FOYA Category Winners and Honorable Mentions for 2019: Best of the Best

The Overall FOYA winner will be announced during the 2019 ISPE Annual Meeting & Expo on 29 October. The FOYA Celebratory Reception and Banquet will take place on the evening of Sunday, 27 October. For more information, go to.

Equipment Innovation: Janssen Cilag SpA

Adapting to Meet Consumer Needs

The Janssen Latina SpA factory site produces 3.8 billion tablets and capsules each year. Built in 1983, the factory has undergone renovations and additions over the years to adapt to market needs. One of those changes has been the use of new and innovative Dosepak packaging and I-Smart technology.

Janssen’s engineers worked with external companies to create state-of-the-art equipment that is unlike any other in the industry. Previously, it took eight steps, three machines, and four production phases as well as two additional manual steps to produce an I-Smart Dosepak. The new equipment combines all the multiple steps and phases into one unique production process that integrates advanced robotics and automations into standard packaging process steps and allows Janssen Latina to launch new products with innovative packaging while keeping production processes lean, flexible, and sustainable.

“Overall, the Dosepak equipment makes the Janssen Latina plant ready to support the introduction of new lifesaving products with special packaging requirements,” said Marco Minotti, Engineering Site Lead. “No other equipment combines standard wallet, Dosepak, and I-Smart handling in one single machine while also having the flexibility to process different products and a wide range of blister and wallet dimensions and reducing the amount of time needed to produce a unit. The equipment increases site capacity and reduces labor costs while being designed and built with the highest safety standards for its category. With this equipment, we are able to produce medicines in a more efficient and cost-effective way, ensuring higher quality and lower costs to patients.”

Facility of the Future: Moderna, Inc.

Creating Medicine of the Future

Since its founding, Moderna has become a leader in messenger ribonucleic acid (mRNA) research and development. Today, the company’s pipeline includes mRNA-based investigational medicines for infectious diseases, immune oncology, rare diseases, and cardiovascular diseases. Currently, Moderna has 21 development programs in its pipeline. Anticipating rapid pipeline growth and recognizing the lack of external capacity to support the company’s ambitious timeline, Moderna management decided in 2015 to construct a dedicated manufacturing facility in Norwood, Massachusetts.

Moderna designed the facility to be highly flexible, adaptable, and capable of manufacturing 100 GMP lots per year for the clinic as well as 1,000 mRNA orders per month. It leverages a “ballroom” concept, with equipment and digital tracking allowing for individual suites to be quickly and easily reconfigured for various uses based on demand. The company’s approach to bringing digital technologies into its workflows and processes, using robotics, automation, artificial intelligence, and cloud-based computing to fulfill the cGMP operating strategy, brings the industry to a new level in the digital era.

“We are excited about the rapid progress we’ve made thus far at Norwood, and we continue to improve and optimize our processes,” said Juan Andres, Moderna’s Chief Technical Operations and Quality Officer. “Our goal is to ensure this facility fully supports our broad research and development objectives and timelines as we work to bring a new class of medicines to patients.”

Facility Integration: Pfizer, Inc.

Delivering Lifesaving Medicine

Pfizer, one of the world’s premier innovative biopharmaceutical companies, was already distributing lifesaving cancer medications, monoclonal antibodies (mABs), to more than 100 countries, thanks to one biopharmaceutical center in Ireland and two in the US, when they decided to build another center in China. Globally, 7 of the top 10 best-selling medicines are biologics, and sales are growing; however, most people in China did not have easy access to mABs, with biologics accounting for only 4% of the medicines prescribed there.

Pfizer partnered with world-class companies and top local contractors from the beginning of the project and treated all partners as peers. They developed shared goals, and Pfizer encouraged a philosophy of mutual respect for all people. With an international effort from teams located in many countries around the world, the project was finished on time, under budget, and with an unparalleled safety record. “Our project was led by a small, experienced management team who were focused and empowered to make all decisions,” said Chaz Calitri, Vice President for Pfizer Manufacturing Operations.

Industry cost, schedule, and safety records were broken as a result of the incredible commitment and dedication from the global execution team. The Pfizer project involved 3,700 people working more than 2.7 million hours with a perfect safety record and no lost-time accidents (the industry average for similar projects is eight lost-time accidents). The Hangzhou project cost of $195 million was significantly less than the cost for similar pharmaceutical projects in China, and the project was completed in 25 months, compared to an industry average of 36 to 60 months for comparable ventures.

Operational Excellence: Kantonsapotheke Zürich

Serving the Needs of a Growing Population

Kantonsapotheke is one of the leading centers of hospital pharmacies in Switzerland. Before Kantonsapotheke replaced and integrated two outdated hospital pharmacies for the Canton of Zürich hospital system, patients often had to wait a long time before receiving the medicine they needed. “The old facilities were not reliable anymore,” said Heinz Obertüfer, a pharmacist, economist and pharmaceutical manufacturing leader in Zürich. “They had many deviations with the medicines, and it always took a long time to investigate and ensure that products were safe and reliable. Sometimes, they had to throw batches away; sometimes, they did not have the right product available.”

In addition to setting up a new pharmaceutical building, Kantonsapotheke also reorganized the organizational setup to ensure Lean structures and clear responsibilities, incorporated robotics to increase productivity, and redefined and reengineered all operational procedures and processing steps.

Now, the new compounding pharmacy offers a broad spectrum of pharmaceutical services, including oral, dermal, and parenteral formulations, often with patient-specific recipes, using the latest technologies and most up-to-date pharmaceutical knowledge. All products are manufactured under industrial cGMP conditions, and the operators have achieved an astonishing 60- to 90-minute turnaround time from diagnostic test to patient delivery.

“Kantonsapotheke will use this project as an example for future ones to improve and standardize manufacturing. The project lifts the basic concept of the hospital pharmacy into the scientific and technological future, creates a benchmark for other pharmacies around the world, and has quickly become a beacon for the way pharmaceutical therapeutics can be effectively delivered to patients,” said Obertüfer.

Process Innovation: Eli Lilly and Company

Launching a First-of-Its-Kind Continuous Manufacturing Facility

Continuous manufacturing (CM) offers new technologies to pharmaceutical manufacturing and new opportunities for safer and greener chemical processes. Eli Lilly and Company has been recognized as an industry leader in this transition. Lilly’s small-volume continuous (SVC) facility combines the practicalities of small-scale processing with the innovations of continuous manufacturing technologies to quickly deliver active pharmaceutical ingredients (APIs).

Before Lilly’s small-volume continuous facility, no other company had simultaneously applied continuous manufacturing technology to the production of multiple process steps, including all process separations steps and API crystallization. The guiding principle of the small-volume continuous facility is that several GMP steps are coupled together so that one step flows seamlessly to the next and all can run at the same time. This allows Lilly to have a much shorter cycle time compared to traditional batch process-es and makes the facility more responsive to supply chain demands to meet patient needs. The facility was used to manufacture APIs for clinical trials of one of Lilly’s potential new cancer drug candidates. This took place in conditions that were safer and more productive than a batch process, and the fully continuous process yielded the first batch of APIs after 2 weeks rather than 2 months.

“This new facility means that Lilly research and development can apply the most innovative approaches to design of continuous processes, in the knowledge that these medicines can now be manufactured with better chemical reaction safety than previously possible,” said Martin Johnson, Senior Engineering Advisor, Small Molecule Design and Development for Eli Lilly.

The project lifts the basic concept of the hospital pharmacy into the the scientific and technological future and creates a benchmark for other phar-macies around the world.

Project Execution: Pfizer, Inc.

Executing on Time and on Budget with a Perfect Safety Record

In 2015, Pfizer decided to construct a state-of-the-art greenfield biotechnology center in Hangzhou, China, to serve the under-developed biologics market in the country. The $195 million project had many challenges, but thanks to a team-centered approach that focused on communication, collaboration, and delivery, Pfizer was able to meet and exceed their goals.

They broke ground in 2016, and 25 months later what had once been an empty field was home to a state-of-the-art drug substance and product manufacturing facility with single-use disposable technology and an integrated lyophilizer and filling line, as well as a high bay warehouse, a central utility building, administrative offices, laboratories, and a cafeteria.

The Hangzhou Global Biotechnology Center was completed with a perfect safety record; there were zero lost-time injuries during 2.7 million hours of site activity. The project team trained 3,700 workers on Pfizer’s safety program. Additionally, the project was completed on time and on budget.

“When asked why this project is viewed as such a success, the overwhelming response is that it all starts with the team,” said Chaz Calitri, Vice Pres-ident for Pfizer Manufacturing Operations. “From the beginning of this project, we knew that the only way to overcome the challenges was to build and empower a small, talented team from inception to startup. They were empowered to make decisions. We used local talent as much as possible, and this helped with language, culture, and training.”

With this innovative project in energy efficiency, our people feel they are working in a facility that can help to put our planet on the path to sustainable development.

Sustainability: Celgene International II

Reaping Long-Term Rewards of a Commitment to the Environment

In 2015, while developing plans for a facility that would be able to meet the growing demand for their existing products and future needs for developing technologies, Celgene made a pledge to apply environmentally sustainable philosophies throughout the design and create a facility where sustainability was ingrained in daily operations.

The site was conceived, designed, and built with a superior energy concept for water heating and cooling, and state-of-the-art, energy-efficient equipment and materials were used throughout.

Celgene’s unique and innovative energy-efficient concepts reduced carbon dioxide output to 1,400 metric tons per year, which is 70% less than output for a standard installation and building construction. Celgene’s total heat requirements are 22% less and their cooling needs 13% less than those of other comparable buildings. Overall, thanks to their forward-thinking measures, the total final energy consumption to meet Celgene’s requirements is 53% less, and the total need for fossil energy (natural gas and fuel oil) is 60% less than that of a standard building.

“With this innovative project in energy efficiency, our people feel they are working in a facility that can help to put our planet on the path to sustainable development. They are proud to share this outstanding realization with their families and our local communities,” said Jacques Soguel, Vice President, Global Engineering & GMP Facilities. “In addition, optimizing our energy usage not only decreases the use of natural resources, but we also see the benefit of reduced electrical costs compared to other manufacturing sites.”

Honorable Mention: AveXis, Inc.

Making Gene Therapy History

Founded in 2013, AveXis, Inc., is a gene therapy company dedicated to developing and commercializing novel treatments for patients with rare and life-threatening neurological diseases. Once AveXis was ready to ramp up production of AVXS-101, a one-time-dose gene replacement therapy for infants born with spinal muscular atrophy, they knew they needed to build a state-of-the-art manufacturing facility.

They were able to do so with innovative execution while meeting the deadlines of a very aggressive timeline. AveXis did not have the benefit of case studies to follow and had to forge their own way. They decided to use equipment that had previously only been used for research and development and to partner with the suppliers to revamp the equipment. Much of the equipment had to be customized or completely redesigned for the facility. The unique manufacturing facility includes modular, single-use technology and cutting-edge manufacturing equipment and systems that are among the first of their kind in the industry.

At the new facility, AveXis can produce gene therapies for commercial distribution and ongoing and future clinical trials. Additionally, manufacturing gene therapies in-house provides AveXis with much-needed control, gives them the ability to make decisions quickly, and decreases production costs.

Honorable Mention: Takeda

Fighting Rare Diseases

Every year, millions of patients depend on plasma-derived therapies obtained through plasma fractionation processes. To meet the growing global need for these lifesaving therapies, Takeda built a 1.1-million-square-foot manufacturing facility on 160 acres in Social Circle, Georgia, US.

The Georgia manufacturing facility is one of the largest greenfield site projects in the United States and one of the largest plasma fractionation sites in the world. The facility is licensed by the US Food and Drug Administration for distribution in the United States, and Takeda has future plans for licensing and distribution into China and European markets.

To successfully build a project of this scale, subject matter experts from around the world collaborated to design, develop, and construct the state-of-the-art facility. In this unprecedented collaborative effort, Takeda relied on an exemplary management team, innovative risk management strategies, and excellent communication to keep the project moving forward.

In addition to having the capability to meet Takeda’s production goals, the facility positively impacts the wellness of employees and was built with a stellar safety record.