Strategic Facility Planning for Cell and Gene Therapy Facilities
Jan 22, 2020
David Keith, Director of Strategic Facility Planning at CRB, was recently featured in Pharma’s Almanac, with an article entitled, “Strategic Facility Planning for Cell and Gene Therapy Facilities.”
In the emerging cell and gene therapy space, strategic facility planning (SFP) can help drug manufacturers ensure that their facilities will be sufficiently flexible to allow for the adoption of new technologies and processes as they are developed.
David explains the role that SFP can play when designing cell and gene therapy facilities (excerpts below):
Key Principles of Strategic Facility Planning
Strategic facility planning (SFP) is a proactive mechanism for establishing facility goals based on the strategic objectives of the organization. It enables optimization of facility design and function and leads to more efficient and productive facilities that are also easier to manage.
The Importance of SFP
Strategic facility planning is critical to understanding the options for a go-forward roadmap, especially when working in a capital-constrained environment. This approach allows companies to identify potential future growth projections and, on the flip side, plan for unforeseen business challenges before these items become critical for executive decision making.
Value of SFP in the Pharma Sector
Given the comprehensive regulatory environment, increasing competition, and growing pricing pressures that drug manufacturers face, SFP has become even more imperative. SFP provides the framework for the design and construction of the facilities so that they have a greater assurance of meeting regulatory requirements and provide a higher level of protection and safety for operators and patients.
SFP Considerations for Cell and Gene Therapies
While cell and gene therapies are often considered together, manufacturing requirements for these advanced therapy medicinal products (ATMPs) can be quite different.
The design of a cell or gene therapy facility depends greatly on the therapy itself and the process used to make it, the targeted indication, and whether the product is patient-specific or an off-the-shelf allogeneic. These factors directly impact the scale and throughput of the facility.