International Biotech Corporation Case Study
A leading biotech company with a focus on biotherapies and vaccines is developing facilities to house new plasma base and sub-fractionation processes. PF is providing a major role as part of a $400 million, ~250,000 square foot, five-story building expansion. PF was chosen to be the owner’s representative, is acting as the co-program manager as well as commissioning and qualification lead, commissioning and qualification automation lead, and construction and engineering manager. PF is also leading the procurement, commissioning, and process engineering of equipment essential to a novel plasma sub-fractionation process. PF established the C&Q program including, but not limited to the following deliverables: C&Q master plan, user requirement specifications, risk assessments, data integrity assessments, design review and qualifications, and FAT/SAT through process qualification.