OR WAIT null SECS
In addition to the traditional FOYA category awards, ISPE recognized two facilities for operational agility during the COVID-19 pandemic.
The International Society for Pharmaceutical Engineering (ISPE) announced the 2021 Facility of the Year Awards (FOYA) Category Winners in an April 27, 2021 press release. The category winners are Takeda Pharmaceuticals International (Facility Integration and Process Intelligence and Innovation), ElevateBio (Operational Excellence), Janssen Sciences Ireland (Project Execution), and Government Pharmaceutical Organization (Social Impact). In addition, Gilead Sciences and Grand River Aseptic Manufacturing received recognition for operational agility during the pandemic.
“Now more than ever, it is important to spotlight the dedication of companies like the 2021 FOYA Category Winners who are at the forefront of setting the leadership example for the design, construction, and project execution of pharmaceutical facilities incorporating unique approaches to innovation, operability, flexibility, and key principles regarding social impact,” said Thomas Hartman, president and CEO of ISPE, in the press release. “COVID-19 has certainly presented significant challenges to the pharmaceutical industry, and the innovations of these dedicated companies has a direct impact in shaping global expectations for the manufacture of effective and safe medicines.”
The Facility Integration Category was awarded to Takeda Pharmaceuticals International for its NINLARO The Grange Castle Factory P2 Facility in Grange Castle, Ireland. The facility demonstrates integration of drug substance manufacture, drug product blistering and secondary packaging, quality control testing, and quality assurance operations in one dedicated building.
ElevateBio was awarded the Operational Excellence Category Award for its ElevateBio BaseCamp in Waltham, Mass. At this facility, cell and gene therapies are rapidly developed and launched.
Takeda Pharmaceuticals International AG won the Process Intelligence and Innovation Category Award for its F36 New Solid Pharmaceutical Production Building in Hikari, Japan. The packaging facility uses digital and automated systems for increased safety, quality, and overall efficiency. Quality-by-design principles were embedded in the project design and execution.
The Project Execution Category was awarded to Janssen Sciences Ireland for its BioCork2–Large Scale Fed Batch Facility in Ringaskiddy, Ireland. The project added biologics drug substance fed-batch capacity at the 15000-L scale.
Government Pharmaceutical Organization (GPO) was awarded the Social Impact Category Award for its Thailand Self Sufficient for Pandemic Vaccines; Influenza and COVID-19 project in Saraburi Province, Thailand. GPO designed the facility for zero-waste and used solar panels to provide electricity.
A Special Recognition award for Operational Agility: COVID-19 Impact went to Gilead Sciences for its Center for Innovative Drug Research (CIDR) in Foster City, Calif., which used interconnectivity between laboratories to expedite therapies. Grand River Aseptic Manufacturing (GRAM) also received a special recognition award for its Large-Scale Fill-Finish Facility in Grand Rapids, Mich., which was built under an accelerated construction schedule.
Honorable mentions went to Biocon Biologics Limited, Locus Biosciences, and the Raymond G. Perelman Center for Cellular and Molecular Therapeutics. The Biocon Biologics Manufacturing (B3) Project in Bangalore, India used sustainable design elements and managed construction safety. Locus Biosciences’ commercial phage production facility in Morrisville, NC built a flexible, three-suite facility in an existing building that provides interchangeable production space. The Raymond G. Perelman Center for Cellular and Molecular Therapeutics in Philadelphia located in the Children’s Hospital of Philadelphia, manufactures adenoassociated and lentiviral vectors supporting clinical trials.