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Clients & Projects > Project Profiles > Antigenics, LLC
Project Description:
SPEC successfully designed, constructed and commissioned a 30,000 square-foot Pilot-Scale manufacturing facility including a vivarium, class 10,000 autologous processing suite, specialized infectious disease laboratories and utility space. In addition the project required R&D lab space, administrative office areas and building site and façade upgrades. Process utilities included; WFI, clean steam, pH neutralization, high-pressure plant steam and an extensive air handling system.
Project Highlights:
Project highlights included SPEC’s ability to provide the conceptual design necessary to prepare a preliminary Establishment License Application (ELA) for submission to FDA for preliminary review. After FDA review, SPEC proceeded to develop a Guaranteed Maximum Price (GMP) package, which included the total scope of work, project budget, project schedule and performance based contract for the project. Due to the fast track nature of this project, SPEC accelerated the procurement phase by pre-purchasing major capital equipment items. Subcontractors that were deemed critical to the success of the project were prequalified and the bid packages were expedited to insure that schedule was met. During the start up phase of the project, SPEC process & controls engineers commissioned the project to provide the client with a functioning facility. Documentation packages were provided to support validation protocols and operator training for all systems was provided by SPEC.
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