Production Facility Modifications

  • Confidential Pharmaceutical Client

Facing potential shortages of vaccines in the face of a public health crisis, the U.S. government took delivery on the needed doses of the H1N1 vaccine with completion of our project to renovate and retrofit an existing facility. The space had been unused for nearly five years, but with concerns over potential pandemic outbreaks of flu strains such as H1N1, the client, in cooperation with the U.S. Department of Health and Human Services, initiated a project to outfit and upgrade the space to ready it for production of pandemic flu vaccines. This multi-million dollar project resulted in completion of the clean rooms and process and utility systems required to meet the FDA requirements for cGMP manufacturing 30 days ahead of schedule. The facility’s functional requirements and capacity were dovetailed around cutting-edge technology: a high speed filling system installed within the core of the facility. With an integrated approach to construction, start-up, commissioning and qualification, our client was able to coordinate post-construction qualification and validation activities at an accelerated pace. This approach permitted them to deliver the overall licensed facility and operate at full capacity 15 weeks ahead of schedule and meeting their obligation to the government ahead of competitors.

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