BioPharma Drug Product Facility

INCOG BioPharma Services, a Contract Development and Manufacturing Organization (CDMO), established a 90,000 SF state-of-the-art drug product facility designed for current needs and  consideration of future expansion. This project was characterized by its rapid pace and careful management of financial resources, and it was executed with the adoption of a Targeted Value Design (TVD) approach.

Our team was pivotal throughout the project’s lifecycle, including preliminary engineering; detailed design; procurement; commissioning, qualification, and validation; and asset management services from 2022-2023. CHA harnessed its experience to execute the engineering phase within a very tight timeframe, running in parallel with the core/shell construction – and accordingly, the facility was an ISPE Facility of the Year Award (FOYA) finalist, noted as “First to Flex” for its rapid execution.

The facility was designed to support the operation of three flexible filling lines with the capability of filling bulk and RTU vial setups, pre-filled syringes (PFS), and cartridges. Our multifaceted scope encompassed process architecture, structural, process, mechanical, electrical, instrumentation and controls, and automation deliverables. Additionally, CHA supported ancillary lab design, created equipment and automation User Requirement Specifications (URS), and developed client-specific design standards and documentation for their ongoing operations. Due to the quality of design and operations, the facility received zero Form 483 observations during their FDA inspection and approval, which they received in early 2024.

The new facility supports INCOG BioPharma Services’ long-term vision focused on sustainability for employees and customers.