Continuous Manufacturing: Support and Implementation

Continuous manufacturing is the future for the Pharma and Biopharma industry.

It can lower manufacturing costs, reduce production footprint (e.g., smaller equipment, less manufacturing space, less safety hazards and improved environmental impact), reduce time to market, improve quality of products and availability to patients.

4TE’s consultancy services will help you make the transition as smooth as possible.


Talk to our experts

Continuous Manufacturing: Support and Implementation

Continuous manufacturing is the future for the Pharma and Biopharma industry.

It can lower manufacturing costs, reduce production footprint (e.g., smaller equipment, less manufacturing space, less safety hazards and improved environmental impact), reduce time to market, improve quality of products and availability to patients.

4TE’s consultancy services will help you make the transition as smooth as possible..


Talk to our experts

Substantially reduce production waste and manufacturing costs

Optimise your CAPEX investment

Reduce time-to-market

Minimise safety hazards

Why should you consider us to support your transition

Transitioning to continuous manufacturing brings challenges. It requires a strong investment, a high level of technological capability, a great product and process knowledge and the ability to control process conditions in real-time. But these challenges can be minimized by a realistic, solid, well-structured business case construction.

Channelling the full potential of continuous manufacturing implementation implies process and product knowledge, requiring state-of-the-art tools, and systematic, science- and risk-based methodologies, such as Process Analytical Technology (PAT), Quality by Design (QbD), models, and risk management tools.

It can seem dauting, but we have the expertise to support through it!

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How can we help your Continuous Manufacturing transition

We believe that our risk and science-based strategies will help you build a solid business-case capable of delivering you substantial gains in product quality, productivity, waste reduction and better time-to-market while de-risking your product and process lifecycle.

You will have a manufacturing system configured with effective process monitoring and the use of PAT tools along the manufacturing process allows developing a robust control strategy, with a higher degree of automation and control over the process.

Last, but not the least, your workforce will be educated and trained in manufacturing and regulatory aspects to make sure your continuous manufacturing activities are supported.

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Working with us will yield results.

Whether you are about to start or already in the process of transitioning to continuous manufacturing we can support you by:

  • Developing the business case identifying gains, requirements, and investment needs.
  • Performing a gap assessment of the existing Pharmaceutical Quality System (PQS) for the manufacturing facility (when not designing a new facility)
  • Performing a gap assessment of workforce skills required to continuous manufacturing activity support
  • Providing the tools for real-time monitoring
  • Defining risk-based and science-based control strategies, including the key elements of the control strategy, such as:
    • Building control of input materials
    • Developing a process monitoring and control approach including a sampling plan and PAT tools and strategies for their lifecycle management (soft sensors & MVDA models)
    • Creating a Real-Time Release Testing (RTRT) strategy
    • Creationg a material diversion strategy
  • Performing comparability studies for the transition from batch to continuous manufacturing
  • Training at different technical and regulatory aspects (PAT, QbD, process control, data analysis, RTRT, regulatory context for continuous manufacturing, etc.)
  • Supporting the implementation of a Continuos Process Verification plan, starting with a risk analysis
  • Building a knowledge structure adjusted to the data-flow of the continuous manufacturing process

Our work on this topic

Nothing shows our experience better than our work on this topic. Here you can find the resources we have produced on Continuous Manufacturing so far.

The solutions we work with

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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 any necessary software that we may have agreed before.
  • If that's the case 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.
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Let's upgrade your production with Continuous Manufacturing!