(Bethesda, Maryland, USA, 8 June 2016) – The International Society for Pharmaceutical Engineering (ISPE) recognized 2016 category winners Baxter BioPharma Solutions and Jannsen Vaccines AG for their exceptional leadership in Drug Shortage Prevention at the 12th Annual ISPE Facility of the Year Awards (FOYA) banquet. The FOYA banquet was held 7 June 2016 in conjunction with the ISPE/FDA/PQRI Quality Manufacturing Conference in North Bethesda, Maryland, USA.
“ISPE is recognizing companies who, by virtue of the accomplishments for which they have won a category or honorable mention, have strengthened their ability to prevent drug shortages or minimize their impact on patients,” said John Bournas, ISPE President and CEO. He continued, “ISPE wants to stress its commitment to drug shortage prevention by recognizing this critical issue in our premier award program.”
Baxter BioPharma and Janssen Vaccines AG have been selected based upon excellence in the drug shortage prevention dimensions which form the framework of the ISPE Drug Shortages Prevention Plan and the ISPE Drug Shortage Assessment and Prevention Tool. Those dimensions include: Corporate Culture, Business Continuity Planning, Robust Quality Systems, Metrics, Communication with Regulatory Authorities, and Building Capability.
Baxter BioPharma Solutions, located in Halle, Germany, is the 2016 FOYA Category Winner for Operational Excellence. Baxter International’s parenteral manufacturing plant undertook a challenging project to add additional capacity to service the CMO market of parenteral oncology and other complex liquid and lyophilized products. Expansion was designed to accommodate the need for lifesaving unit dose products, with flexibility and efficiency to offer both large-scale, small-scale liquid and lyo vial filling, aseptic formulation, terminal sterilization, and flexible formulation capacity for a variety of challenging oncologic and other sophisticated parenteral products, small molecules, biologics, antibody-drug conjugates, emulations, liposomes, and suspensions. Intent was to provide full services “under one roof” that facilitate short startup time and minimize transfer costs.
Janssen Vaccines AG, based in Bern, Switzerland, is the 2016 FOYA Awards Category winner for Project Execution Category for the “Fast Track Refurbishment for Ebola Vaccine Production”. In 2014 Janssen, the pharmaceutical division of Johnson & Johnson, responded to the Ebola outbreak in West Africa and committed to accelerate the development of its candidate Ebola vaccine. While the first volumes were produced in pilot scale, an idle facility was being refurbished for the scaled-up process providing a launch capacity of up to 5 million doses annually.
In addition to the special recognition for their leadership in Drug Shortage prevention, the following companies were recognized as the ISPE Facility of the Year Awards (FOYA) program 2016 Category Award winners:
Baxter BioPharma Solutions (Operational Excellence)
Ethicon, LLC (Sustainability)
Genentech (Process Innovation)
Janssen Vaccines AG (Project Execution)
Pfizer, Inc. (Equipment Innovation)
Takara Bio, Inc. (Facility Integration)
FOYA’s judging panel has also awarded Honorable Mentions to: Greater Pharma Co., Ltd., University of Strathclyde, and West Pharmaceuticals Services, Inc.
About the FOYA Awards
The Facility of the Year Awards are an annual program that recognizes state-of-the-art projects utilizing new, innovative technologies to improve the quality of products, reduce the cost of producing high-quality medicines, and demonstrate advances in project delivery.
The FOYA program is unique because it 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 applications of technology and cutting-edge approaches that it is adopting.
More importantly, it's about recognizing the shared commitment and dedication of individuals working for different companies worldwide to innovate and advance pharmaceutical manufacturing technology for the benefit of all global consumers.
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 the category winners and the overall Facility of the Year Award winner.
The International Society for Pharmaceutical Engineering, 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 20,000 members of ISPE are building solutions in the development and manufacture of safe and 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 in Bethesda, Maryland, USA, and an operations and training center in Tampa, Florida, USA. Visit www.ISPE.org for more information.