Scaling Up Production Capacity and Efficiency for a Microbiome Therapeutics Company

Context

The client had developed an innovative process to utilize microbes to address widely prevalent intestinal disorders. They were operating at a limited commercial scale and were looking to scale their production. They had just received regulatory approval for their first-of-a-kind therapeutic. They were on a tight timeline and budget to expand their manufacturing program. They needed to clearly understand their costs, scale up three major manufacturing programs and facilities, and evaluate whether to work with commercial partners or build their own plant.

Process

The Next Rung Team helped the client scale in an economically feasible way with the following steps:

• Capital Cost Estimation

  Our process engineers and business analysts leaned into their real-world experience to create complete and accurate cost estimates for every aspect of scaling up. This work included cost estimates on:

  • Donor collection facility process scale-up and definition

  • Labor costs at a larger scale

  • Utility costs

  • Subcontractor payments

  • Commercial manufacturing options

  The deliverable was a thorough break down of the $200 million capital cost that was required to successfully scale up to the level they desired.

• Technoeconomic Analysis and Modeling

  The next step for the Next Rung Team was to combine the process diagrams from the client company with their capital cost estimate to create a dynamic model of unit economics at each step of the process. This model broke down assumptions and mapped them to each step of the process to guide how they would work with the client to scale their operations to the next level. This model also supported in-depth case study evaluations of trading off upstream, midstream, and downstream activities.

• Market-Driven Manufacturing Planning

  Since the client was operating within an emerging market with shifting regulations, Next Rung Technology helped them create a manufacturing plan that tied capacity to the market projections and clinical development plans for their product, making sure the capacity scaled appropriately to match the external market for their product.

• Manufacturing Site Selection and Project Management

  Next Rung Technology then worked with the client team to create a clear execution timeline for scaling up manufacturing. They conducted a search and selected sites that matched the company’s location and that implemented GMP (good manufacturing practices).

• Subcontractor Evaluation, Management, and Procurement Support

  After creating the execution plan, the CMO’s and EPC’s were evaluated using a matrix with the cost and criteria that partners must match to be a good fit.

  To evaluate CMO’s, Next Rung business analysts created an equation that produced a score based on things like operating costs and markups.

  For EPC’s, Next rung created an equation that graded potential partners based on flexibility, scalability, and long-term relationship potential.

  Next Rung worked with the client to select the optimal partners, then integrated those partners into the larger project plan to ensure things stayed on timeline as the Owner’s Engineer.

Outcomes

As a result of Next Rung Technology’s accurate estimates and efficient project management, the client company saw a production capacity increase of 300% and a production efficiency increase of 500%-1,000%, while staying within the outlined budget and timeline.

The partnership continues, and Next Rung Technology played a large part in expanding the client’s manufacturing to pilot scale and anticipates supporting the project through commissioning and startup.