ISPE Recognizes Leaders in Drug Shortage Prevention
The International Society for Pharmaceutical Engineering (ISPE) recognized 2016 category winners Baxter BioPharma Solutions and Janssen Vaccines for their exceptional leadership in drug shortage prevention. At the 12th Annual ISPE Facility of the Year Awards (FOYA) banquet held in June in North Bethesda, Maryland, USA, the society’s president and CEO, John Bournas, said: “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.”
Baxter BioPharma’s site in Halle, Germany, and Janssen Vaccines’ facility in Bern, Switzerland, 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.
FOYA Category Winners
The Facility of the Year Awards (FOYA) 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.
Baxter BioPharma Solutions is the 2016 FOYA category winner for Operational Excellence. The US company’s parenteral manufacturing plant in Germany (cf. photo) undertook a project to add additional capacity to service the CMO market of parenteral oncology and other complex liquid and lyophilized products. Intent was to provide full services “under one roof” that facilitate short startup time and minimize transfer costs.
Janssen Vaccines 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 FOYA 2016 category award winners:
Ethicon’s facility in San Lorenzo, Puerto Rico, was awarded the Sustainability category prize for the site’s sustainability efforts that resulted in energy reduction of 26% and water reduction of 9%, while increasing production volume by 11%, compared to 2010 consumption levels.
Genentech won the Process Innovation category for their large scale, Cell Culture Biologics Drug Substance Plant 2 (CCP2) located in Vacaville, California, USA. This project focused upon an upgrade to the original facility, put into an idle but “keep warm” status in 2010, combined with a fast track Return to Service project.
Pfizer’s Groton, Connecticut, USA site is the category winner for Equipment Innovation. Pfizer, GEA, and GCON Manufacturing formed a consortium to design and build a portable, autonomous manufacturing environment for continuous oral solid dosage production using GEA’s ConsiGma25 system and G-CON's modular system.
Takara Bio’s Center for Gene and Cell Processing (CGCP) in Kusatsu city is being recognized for its innovative use of facility integration to house cell products, viral vectors and recombinant proteins within the same facility.
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