It's finally time to scale-up your process!
In order to make the most out of it and to ensure highest-standards of quality in the shortest time-span possible, you need a solid strategy and implementation plan.
We can help you with that.
Process Scale-up Strategy and Implementation
It's finally time to scale-up your process!
In order to make the most out of it and to ensure highest-standards of quality in the shortest time-span possible, you need a solid strategy and implementation plan .
We can help you with that.
Reduced time-to-market
High standards driven by a QbD approach
Data-based process design decisions
ICH, EMA and FDA Guidelines Compliance
Scaling-up is excellent news, you’re getting closer to bringing your product to the market.
Having the right strategy to bring your process from lab to pilot and then to the commercial stage can have a strong impact in your time-to-market, in your product quality and, of course, in your process yield – and all of this makes your process an asset to the business of your company.
The goal should be simple: accelerate the process with optimisation and quality in focus.
We believe in the power of the design of experiments (DoE) bearing the quality and efficiency in mind. In this way we can, with a reduced set of experiments, produce an informative dataset from an early stage – which will allow us to minimize long and costly assay activities.
We use that data to characterize the process, to understand how the process will evolve, to assess what is critical and therefore to decide what must be controlled.
When we’re done, you will have: