IPS assessed the capability of current building to be fit-out for the manufacture of monoclonal antibody products utilizing single-use technology platforms for upstream and downstream operations.

IPS completed an assessment to convert existing, unoccupied 2^nd floor space into disposable manufacturing operations for contract manufacturing of mAb protein drug substance.

IPS reviewed the implementation of various single-use technology and defined three potential options that would provide clear, unidirectional process flows and defined segregation; provide viewing windows into the major manufacturing areas; and focus on the efficient utilization of utility and existing building systems.

IPS Highlights

• Provided an analysis of a next-gen manufacturing option to provide the maximum flexible use of floor space
• Provided flexibility in the design to implement a variety of single-use technology platforms
• Identified alternatives for expansion capabilities
• Provided flexibility and adaptability to achieve the client's goal of increasing contract manufacturing operations
• Maximized schedule execution to allow a rapid-entry option
• Evaluated each utility system’s current capacity and the ability to meet the new demands due to expanded manufacturing capability
• Evaluated then recommended manufacturing-based waste handling due to significant increase in single-use waste materials