GSK and ViiV Healthcare were awarded with the ISPE 2020 Facility of the Year Awards for constructing and commissioning a dedicated facility in 15 months to bring to market a new medicine for people living with HIV and ensure continuity of supply of fostemsavir.
The limited product knowledge, as it was acquired form a third party who stopped clinical development, brought unusual challenges. The team collaborated closely with colleagues across all developmental functions and regulatory authorities to understand the impact of the drug on facility design and operation.
To deliver the project, the team used the novel delivery approach of “Integrated Project Delivery” (IPD) never used before in Italy. They paid attention to creating a “can do” attitude and culture whilst implementing accelerated delivery tools such as building information modelling and 3D visualization from design inception to handover enhance collaboration. This pre-construction project visualization improved coordination of scheduling and sequencing throughout the project and was contributory to the excellent safety performance of zero reportable incidents.
For the third time GSK chose IMA Active as main supplier for containment solutions and solid dose processing machines. Once again IMA Active has confirmed its competence and experience. The plant is equipped with IMA state-of-the-art machines to ensure the best and most consistent product quality. Besides the supply of an integrated equipment specifically designed for fostemsavir manufacturing in containment with dedicated control systems, IMA Active experts shared their knowledge to deliver the project and provide assistance for process start-up and optimization.
As a result of this work, ViiV Healthcare continued the clinical trials and has been able to complete regulatory submissions to the FDA and CHMP. The company is expecting approval of fostemsavir in the US and Europe in 2020.
For further information visit the ISPE website.
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