“Antigenics (now Agenus) mission is to enhance and extend lives through the development of superior health care products for a wide range of cancers, infectious diseases and autoimmune disorders. Lead Products in Development at Antigenics Oncophage (vitespen; formerly HSPPC-96) and AG-858 (HSPPC-70). Investigational personalized cancer vaccines based on Antigenics heat shock protein technology. Oncophage has been evaluated in Phase 3 trials and has received fast track and orphan drug designations from the US Food and Drug Administration for both kidney cancer and metastatic melanoma.” From the Antigenics’s website
SPEC began working with the client to provide the conceptual design necessary to prepare a preliminary Establishment License Application (ELA) for submission to the 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.
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.
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.