Approaches for Flexible Manufacturing Facilities in Vaccine Production - With careful analysis to mitigate risk, disposable technology and process closure can enable adaptable designs and reduced

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Approaches for Flexible Manufacturing Facilities in Vaccine Production
With careful analysis to mitigate risk, disposable technology and process closure can enable adaptable designs and reduced costs.


BioPharm International Supplements
pp. s22-s28

FUTURE FACILITY CONCEPTS


Figure 2: Fault-tree analysis for system closure.
By leveraging closed systems and maximizing the use of single-use systems, it is possible to design a facility that allows work areas to be combined and room classifications to be lowered. Such a facility offers many benefits; in studies done by CRB for a number of biophamaceutical clients where the FutureFacility concepts were utilized and the corresponding facility costs, utility costs, and cost of goods were examined, advantages included:
  • Reduced manufacturing area (by 15–30%).
  • Reduced HVAC (resulting in reductions in room classifications, gowning, cleanroom areas, air changes per hour, fan power demand, number of air handling units, and maintenance).
  • Reduced utilities (single-use systems can reduce clean steam and water-for -injection requirements by up to 80–90%, chilled water and steam demands are reduced by up to 60%, and wastewater is also reduced.
  • Reduced construction and start-up schedule (by 30–50%).
  • Possible reduced cost of goods.


Figure 3: FutureFacility concept for vaccine-manufacturing facility.
In the FutureFacility concept (see Figure 3) for a vaccine manufacturing plant, a contained zone is provided for the virus work, while the nonviral support functions, as well as the post inactivation steps are combined into a single room. Such an approach reduces the circulation areas of corridors and airlocks, maximizes the efficiency of labor, and offers the maximum in flexibility for changing processes. Each unit operation is connected to utility plates in the ceiling and can be readily relocated to accommodate various processes. Even the containment area can be demounted and removed, should biocontainment no longer be necessary, for example if a monoclonal antibody operation is inserted into the facility. Inoculum preparation operations in the FutureFacility utilize isolators with integrated incubators and directly adjacent seed bioreactors. Cell buildup for the viral process is outside of the containment zone, and transfer into the production bioreactors at the final stage.


Figure 4: Schedule showing how shorter project times compared with those of a traditional stainless-steel facility can allow for improved time to market; or for added time for process development, clinical result generation, and business planning before committing to major capital investments.
The design and construction schedule for this sort of facility is significantly shorter than a traditional stainless steel facility. Time spent on design and construction is reduced because of lower system and building complexity and reduced piping requirements, and procurement of single-use systems avoids the long lead times associated with stainless steel equipment. Time saved on design and construction can be used to improve time-to-market, or if the project initiation is delayed, it can be used to allow additional process development time, or to have more certainty in clinical results before committing to major capital investments in a facility (see Figure 4).


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