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.


Talk to our experts

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.


Talk to our experts

Reduced time-to-market

High standards driven by a QbD approach

Data based process design decisions

ICH, EMA and FDA Guidelines Compliance   

Why

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.

 
...

How does it work

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:

  • Defined an appropriate manufacturing process and its critical process parameters (CPPs) in the new scale. 
  • Obtained a comprehensive tech transfer document including all the important parameters of your process, analytical procedures and critical quality attributes (MoA, CQAs etc.)
  • Re-assessed the quality attributes of the drug substance and the drug product prior to scale-up. 
  • Established a control strategy for the scaled-up process.
  • Transfered the existing models to the new scale.
  • Documented the tech transfer in depth.

The stages of product lifecycle that we impact

4TuneEngineering 4TuneEngineering lifecycle

The solutions we work with

consulting irisk riskregister isee

What can you expect when you work with us

  • We will have a Pre-project meeting so that we can understand your expectations in the short and medium-term.
  • When everything is lined-up, and if you are happy, we will enter into contract.
  • Our teams will meet to formalize the project kick-off, covering the project scope, schedule, milestones, deliverables, and anything else that is necessary.
  • We will install the necessary software with any customizations that we may have agreed before.
  • We will define Software training dates for your team in order to make sure you can make the most out of Risk Management Digitalization.
  • We will provide you support and follow-up during our partnership.
software-print

Let's move your process to next the stage!