Celebrating Innovative Engineering Solutions in the Life Sciences Industry
ISPE’s Facility of the Year Awards (FOYA) celebrates cutting-edge engineering, new technology, and unique collaborations. It provides a platform for the pharmaceutical science and manufacturing industry to showcase accomplishments in facility design, construction, and operation, new applications of technology, and cutting-edge solutions that solve drug shortage issues, improve safety and efficiency, and reduce environmental impact.
Winners and well-wishers celebrated the projects during a FOYA banquet at ISPE’s 2021 Annual Meeting & Expo in Boston, MA.
We received a lot of excellent submissions this year and it was incredibly difficult to narrow down to these select winners. We are honored to share their stories with you as we celebrate these 10 projects who all embody the spirit of FOYA.
Since FOYA started in 2005, we’ve made regular changes to the awards in keeping with changes in technology, innovation, and impact to the bio-pharm world. Tonight’s winners join an elite league of over 115 winners from 20 countries. Our industry has been in the spotlight more than ever as we developed vaccines and treatments for the ongoing global health crisis. I would like to commend our current winners for their achievements this year, but also recognize many of our past winners who worked diligently to make it possible that we could all be here together in person here in Boston.
“As we recognize tonight’s winners, we have to remember that these projects were submitted about a year ago. In the middle of navigating lockdowns, travel restrictions, supply shortages, personnel, and work from home protocols,” said Vermunt. “As I reflect on what these winners did, several things stand-out to me. The first is innovation. We all want to see the most cutting-edge technology incorporated into these projects, and this year was no different. We see the realization of Pharma 4.0 in Takeda Japan’s Process Intelligence and Innovation win, but we also see innovation in Locus Bioscience’s pioneering product, Takeda Ireland’s facility implementation, as well as ElevateBio’s novel take on industry ecosystem.”
Takeda Pharmaceuticals International AG won two awards: the Process Intelligence and Innovation award for their F36 New Solid Pharmaceutical Building and Automatic Line Clearance in Hikari, Japan, and the Facility Integration award for a project in Ireland. The F36 project includes a fully automatic end-to-end packaging line with a high level of equipment automation, AGVs, and an innovative fully automated best in class line clearance check system. “This is the first time ever an automated line clearance has been implemented in the pharma industry connected with artificial intelligence,” said Gunter Baumgartner, Senior Vice President, Head of Global Engineering for Takeda. “The team was able to achieve in the packaging area a line clearance from approximately 30 min average down to one minute. Everyone knows that in a manufacturing area where you have many different products, this is a breakthrough.”
The Grange Castle Factory P2 Facility in Ireland includes drug substance manufacture (DS), drug product (DP) blistering and secondary packaging, QC testing, and QA operations in one dedicated building. Before completing the project, production of Takeda’s oncology medication, Ninlaro, was spread across 4 different facilities. “We are an integrated facility, an exciting facility delivering oncology products for Takeda,” said Cyril Buckley, Vice President, Head of Engineering Plasma, Takeda, when accepting the award on behalf of the team in Ireland.
Locus Biosciences’ Commercial Phage Production Facility Upfit, a cGMP commercial phage production environment with maximum flexibility to generate, purify, and aseptically fill therapeutic doses of antibacterial phage to fight critical unmet medical needs and diseases won an Honorable Mention award.
ElevateBio won the Operational Excellence award for their BaseCamp project, a dedicated cell and gene therapy technology, research and development, process development, and manufacturing facility. Home to leading scientists and academic researchers who are working with medical centers and corporate partners to advance cell and gene therapies, BaseCamp is a cGMP facility where those, and other, therapies can be made safely and cost-effectively. "We're not a large pharmaceutical organization, so we relied on our partners from the beginning, from construction all the way through operating the company,” said Mike Paglia, Chief Operating Officer, ElevateBio. “So many partners collaborated to make BaseCamp what it is today."
Another key factor for the winning projects that Vermunt pointed to was agility. “The judges awarded projects in a special category related to COVID-19 responses for Grand River Aseptic Manufacturing (GRAM) and Gilead Sciences. We will need to follow these examples and more to address future global health needs.” Both companies won Operational Agility: COVID-19 Impact awards.
Grand River Aseptic Manufacturing (GRAM) won for their Large-Scale-Fill-Finish-Facility. GRAM is an injectable contract development and manufacturing organization and because of the smart choices they made throughout the planning and construction phases and ongoing team collaboration, they were able to run a first batch of a COVID-19 vaccine candidate six weeks ahead of their original operational schedule. “This award highlights all of the things that came together over the years. In 2021, we’re saving lives,” said Tom Ross, President and CEO, GRAM.
Gilead Sciences won for their Center for Innovative Drug Research (CIDR). Before CIDR was built, Gilead’s researchers and their laboratories were spread across six different facilities on the company’s 101-acre campus in Foster City, California. Now the CDIR is home to 12 different research teams including virology, pathobiology, biomarker sciences, oncology inflammation, fibrosis, and immunology. The facility was consciously designed to be agile and collaborative and research collaborations have already resulted in new discoveries such as an effective therapy for COVID-19. "In my 30 plus years in life sciences I can say that the measure of success of a life sciences company is not by its stock price or its market cap, it's by its social signature, its impact on moving humanity forward and this is exactly what Gilead intends to do, as we have done since Michael Riordan founded the company in 1987 - to leverage the Center for Innovative Drug Research as a means to bring therapies to patients with unmet medical needs around the globe," said John Moser, Senior Director of Facilities Engineering, Gilead Sciences.
The final thread all winners had in common was, “a demonstrated excellence through the power of teams and a sense of giving back,” said Vermunt. “You cannot deny feeling how important this is while learning about Government Pharmaceutical Organization (GPO), Children’s Hospital of Philadelphia (CHOP), Biocon, and Janssen’s projects.”
Government Pharmaceutical Organization (GPO) won the Social Impact award for their Biological Product (Vaccine) Production Plant in Saraburi Province, Thailand, which gives equal access to vaccines for all Thai citizens in a zero-waste facility. “Vaccines are the most successful and cost-effective medical solution to combat diseases that affect the whole population,” said Dr. Withoon Danwiboon, Managing Director, GPO. “Even before the COVID-19 pandemic, Thailand recognized that there was a threat of a possible pandemic and invested in a new vaccine manufacturing facility to make vaccines of high quality and affordable cost for the people of Thailand and the region.”
The Raymond G. Perelman Center for Cellular and Molecular Therapeutics at Children’s Hospital of Philadelphia (CHOP) was awarded an Honorable Mention for the new facility which has the capacity to produce personalized gene therapies, manufacture adeno-associated virus vectors and lentivirus vectors, and support multiple trials simultaneously. “I am humbled to be here. This enormous task challenged us all,” said Johannes van der Loo, Director, Clinical Vector Core, CHOP. “The first patient we treated is 16 years-old and after 1 year of intervention, she is cancer free. “
Biocon Biologics Limited Manufacturing (B3) Project which consolidates the development, manufacturing, and commercialization operations for biosimilars into one facility also won an Honorable Mention award.
Janssen Science Ireland won the Project Execution award and was the overall FOYA award winner for their BioCork2 project. Janssen expanded their existing biologics manufacturing facility to ensure a sustainable supply of lifesaving medicines for patients. The project included adding large-scale fed batch technology, the first of its kind in Ireland and for Johnson & Johnson globally. The project nearly doubled the facility’s manufacturing space, adding more than 200,000 square feet to the existing 280,000-square-foot campus. The expansion also provided full time employment for an additional 200 people and is designed to produce 72 batches of monoclonal antibody product a year. "We were focused on first the patient, second the employees, third the community,” said Jim Breen, Vice President Lead Biologics, Janssen “It's a little bit like J&J's credo, something that General Johnson put together about 75 years ago - take care of the patient, take care of your employees, take care of the community and then you will do very well.”
ISPE developed the Facility of the Year Awards program to recognize the best newer and renovated Pharmaceutical manufacturing facilities that combine all aspects of the building into a superior working environment. The Judges Team consists of prominent industry leaders with extensive global experience and the members of the FOYA committee represent a global cross-section of the pharmaceutical industry.
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