Our client in the biotechnology industry retained Cheme to design, optimize, implement, and validate their existing biologic manufacturing process. New processes and equipment replaced aging and obsolete equipment and installed in their existing facility. Five critical process steps were completely redesigned, while two additional utility systems were refurbished and automated.
Although process requirements were largely defined by the existing process parameters and specifications, the client gave Cheme substantial creative freedom to design new systems. These systems were optimized to reduce processing times, enhance containment and biosafety, and maximize ease of operation.
Cheme provided conceptual design, detailed design, procurement, project management, commissioning, and validation services for all five process systems and two utility systems. The novel manufacturing process was built in the client’s existing facility, including systems such as clarification, sterile filtration, stainless steel and single-use vessels, ultrafiltration, and automated clean utility distribution.
Highlights of this project’s success include outstanding reviews from operations staff in terms of ergonomics and ease of use, and a near-doubling of the product titer compared to the previous process. Additionally, compliance with modern standards for data integrity, biocontainment, and equipment cleaning were not only enhanced, but now hold the standard for the client’s expectations for future projects.