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

of process and product quality 

Data-based

process design decisions 

ICH 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 to pilot and commercial scale 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.

 
...

How does it work

We believe in well-designed experiments, which are carefully planned and thought out from the outset of formulation development – experiments that will produce quality data from an early stage – which can minimize lengthy and costly repetition of scale-up activities.

We use that data to characterize the process, how the process should evolve, what is critical and must be controlled.

...

When we’re done, you will have:

  • Identified the CQAs of the product and how they can be controlled. 
  • Determined the quality attributes of the drug substance and its drug substance and drug product. 
  • Defined an appropriate manufacturing process and its critical process parameters (CPPs). 
  • Established a control strategy for the process.

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!