Feasibility study determines best path for plasma-derived therapy increase
When a global biotechnology company identified the growing need for plasma products in its home country, the renowned leader in plasma-derived therapies set a goal to increase local manufacturing capacity. The company hired CRB to perform a feasibility study to uncover the hidden capabilities within nearby brownfield sites and evaluate their potential.
Delivering an effective feasibility study and strategy:
1. Alignment of goals
Early-stage stakeholder alignment created the foundation for developing the feasibility study’s framework and scope. Not only would the site need to meet increasing immunoglobulin demand for plasma-derived products, but the facility would need to meet the company’s high standards for quality and keep in step with the best practices used at its sites around the world.
Together, our teams established these factors for success:
- Increase manufacturing capacity significantly with the possibility of future expansion
- Maintain continuity of existing supply
- Implement facilities that satisfy global quality and pathogen segregation expectations
- Incorporate best practices to minimize operating costs
2. Project scope
The feasibility study focused on two existing sites and considered various opportunities for both locations, including new facilities and upgrades to the existing facilities.
Developing or expanding a plasma-derived therapy manufacturing facility must take into account plasma fractionation, plasma purification, filling and packaging. The plasma manufacturing environment must be designed to support large-scale equipment, cold processing temperatures, hazardous material storage, solid waste removal, and high product throughput. Adding to the study’s complexities, this biotechnology company was exploring twelve different plasma-derived products for the site.
Our team of engineers, who are well-versed in plasma-derived therapies, performed a deep analysis of both sites. They developed a feasibility level layout and several test fits to assess existing buildings and potential new buildings to accommodate capacity. The evaluations also considered both sites’ existing filling, lyophilization, and packaging operations to determine capability for handling the proposed volume of plasma products. The study included utility capacity, warehouse potential, equipment needs, functional area designs, cost, and estimated timelines.
As the study progressed, CRB’s engineers eliminated various options that we determined were incompatible with project drivers. Some of the disqualifying factors included aging equipment, the level of difficulty to incorporate new equipment, and cost-prohibitive elements. A large part of the value provided by feasibility studies is the identification of potential hurdles and problematic options well before significant investments are made.
4. Data, reports, and direction
Over the course of three months and the in-depth study of both brownfield sites, CRB was able to equip the biotechnology company stakeholders with the critical information and recommendations needed for its site planning process. We presented our client detailed reports on solid waste handling, evaluations of existing layouts, electrical classifications, occupancy class, space assessments, piping options, and infrastructure and layout limits. Additionally, we supplied our client pre-concept layouts and flow diagrams, cost estimates, high-level schedules, and preliminary code analysis as supporting documentation to our feasibility study findings.
The feasibility study reduced risk to the client by providing fact-based assessments of whether these site candidates could offer a worthwhile path forward for the intended project in alignment with the client’s objectives and reservations.