The pharmaceutical industry is undergoing a seismic shift. As the biopharma market expands into new modalities, manufacturers need to move faster than ever before to manage multiple, complex product pipelines. Extraordinary demand is straining manufacturers’ ability to provide production capacity. As these unprecedented trends have converged, innovative solutions will be required to expedite the delivery and operation of flexible facilities that seamlessly support these modalities from clinical development all the way through commercialization.
In a previous white paper Modular and mobile: Improving the biomanufacturing facility lifecycle using a standardized, modular design and construction approach the benefits of a modular design approach were outlined, with an example of a commercial-scale monoclonal antibody (mAbs) facility. Here the approach is applied to a multi-product viral vector (VV) facility at late-clinical/early-commercial scale, showing how significant speed benefits can be gained at each stage of facility design, procurement, construction, qualification and operation.
By taking a modular design approach to biopharmaceutical production facilities, the design solution for the client can be rapidly iterated and assessed against multiple relevant scenarios to aid decision making and speed justification and initiation of the projects. Following the rapid design phase, there are many more speed and cost benefits from repeatability through procurement, off-site fabrication and factory acceptance tests (FATs), simplification of on-site assembly and fit out, and qualification and operation. In all, this can take months or even years off a facility timeline, as well as reducing schedule, cost and regulatory approval risks. This can culminate in taking a modular capacity approach to take a phased approach to investment with major benefits to financial and business risk.
We have shown the approach with our viral vector example, but it is also ideal for the challenges of newer modalities like mRNA and novel processes where uncertainty is high, but flexibility and adaptability can be built in in an informed manner using extrapolation from existing process art and prior knowledge. The team hopes that industry will continue to apply this approach and gain the significant benefits that ultimately provide more therapies to more patients as fast as possible.