Microbe to Manufacture · Process development and scale-up
MtoM — Microbe to Manufacture.
MtoM (Microbe to Manufacture) is the process-development module of SAC. It develops fermentation, recovery, analytics and scale-up around a strain, with quality attributes, recoverability, cost and transfer in view from the first run — and with the fermentation data from every scale feeding a system that establishes the process and predicts its cost.
The scale-up risk
Titer alone does not determine commercial viability.
A high concentration in the fermenter is only the beginning. The material still has to be recovered at an acceptable loss, purified to the specification the application needs, formulated into a usable form and made the same way each time. A process that fails at any of these points does not become a product.
MtoM is built to surface those constraints early. Recovery, quality and cost questions are asked while the fermentation is still being designed, and every scale-up step is treated as a gate with criteria agreed in advance rather than a milestone to be celebrated.
Module 04 · MtoM
From laboratory development to manufacturing partners.
CutisBio develops and characterises processes in the laboratory. Pilot validation uses shared facilities, followed by technology transfer and production with manufacturing partners. The route is defined for each programme.
The precision-fermentation data from each rung feeds the MtoM system, which establishes the large-scale process and predicts manufacturing cost before a partner commits capital.
CutisBio
Laboratory development
Develop fermentation, recovery and analytical methods; characterise the process.
Shared facilities
Pilot validation
Evaluate the integrated process and application fit; define the criteria for transfer.
External manufacturing partners
Manufacturing transfer
Document process and quality requirements for the manufacturing site.
MtoM · Microbe to Manufacture
Process data → validation criteria → transfer documentation
How it works
From the fermenter to the application.
Five stages, each designed with the next one in view.
Fermentation: How the strain is cultivated and controlled so that its performance holds as the scale changes.
Harvest: Separating cells and broth in a way that keeps the product intact and the next step simple.
Purification: Recovery steps chosen for the material’s specification and for what the application can tolerate.
Formulation: Bringing the material into a form that is stable, handleable and ready for the partner’s workflow.
Application: Testing in the real use case, then transfer and supply through the partner’s route to market.
Development pillars
Quality and transfer considered from the first run.
Critical process parameters (CPPs) are the settings a process must hold; critical quality attributes (CQAs) are the properties the product must meet. Defining both early is what makes a process repeatable and transferable.
CPP/CQA definition
Agreeing which parameters must be controlled and which product attributes must be met, before scale-up begins.
Process robustness
Understanding how the process responds to variation so that it performs consistently across runs and scales.
Downstream recoverability
Designing the fermentation and the recovery together so that the product can actually be captured, not just made.
Product quality
Identity, purity and functional attributes measured with methods defined alongside the process.
COGS feasibility
Assessing whether the process can reach a cost structure the application can support, as a design input rather than an afterthought.
Tech transfer
Documenting the process so that a manufacturing partner can run it as intended.
Stage-gate panel
Scale-up as a sequence of decisions.
Each stage ends with a gate. The criteria are agreed with the partner before the stage begins, and the next stage starts only when they are met.
- 01Lab confirmationStrain performance, product identity and first quality attributes confirmed at laboratory scale.
- 02Engineering scaleFermentation and recovery characterised under conditions that anticipate the plant, and the criteria for the next stage confirmed.
- 03PilotThe complete process shown to run end to end, with material available for application testing and specification.
- 04Manufacturing transferThe documented process handed to a manufacturing site or partner.
Deliverables
What a partner takes away.
The outputs of an MtoM programme are documents and materials a partner can evaluate, specify against and hand to a manufacturer. Scope is agreed for each programme.
- 01
Process description
The fermentation, recovery and formulation sequence, with the parameters that must be controlled.
- 02
Analytical methods
Methods for identity, purity and functional attributes, ready to be transferred with the process.
- 03
Material specification
The attributes and acceptance ranges the material must meet for the intended application.
- 04
Transfer package
Documentation assembled so that a manufacturing site or partner can reproduce the process.
Related products and research
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Partner with CutisBio
Build a roadmap to scale
Whether you have a strain, a molecule or an application in mind, tell us the target and the volume horizon. We will propose a staged route and the criteria that would govern it.