Cell & Gene Therapy Digital Risk Management

Cell and Gene Therapies (CGT) have advanced significantly in recent years, with more companies investing in this type of products.

As with all product development processes, risk management has an important role on demonstrating patient risk mitigation.

To help you with that, 4TE delivers specialized Quality Risk Management (QRM) for CGT built on top of our consultancy services and QRM digital platforms.


Talk to our experts

Cell & Gene Therapy Digital Risk Management

Cell and Gene Therapies (CGT) have advanced significantly in recent years, with more companies investing in this type of products.

As with all product development processes, risk management has an important role on demonstrating patient risk mitigation.

To help you with that, 4TE delivers specialized Quality Risk Management (QRM) for CGT built on top of our consultancy services and QRM digital platforms.


Talk to our experts

Deliver consistent patient therapeutic outcomes

Obtain insights for science-based decisions

Establish of robust control strategies

Ensure product quality and QRM process compliance

Implement effective 4.0 approaches

The challenges of the Cell and Gene Therapy Industry

When it comes to Cell and Gene Therapies, it's important to assure quality compliance during the whole manufacturing process. The reason is because these types of advanced therapies have more quality attributes than small molecules, which makes product specifications more complex.

The challenge resides inestablishing a capable control strategy for this type of products, that require not only a huge effort in screening quality attributes,but also accept residual uncertaintythat will always be present over all stages of development and manufacturing.

One of the solutions comes for effective end-to-end integration of operations over a product's lifecycle. This in addition to the capabilities of combining knowledge across clinical programs and product portfolios,will enable you to obtain predictive and designed clinical outcomes.

Also, having a risk-based framework capable of managing residual risksof incompletely defined systems, will deliver the promise of an industry for agile patient outcomes.

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How can Cell and Gene Therapies be adapted to include patient outcomes.

We are sure that following these approaches, your company will be able to deliver consistent patient therapeutic outcomesfor your CGT products.

Starting by providing end-to-end and over lifecycle linkage of CGT operations, from development to manufacturing, our effective 4.0 approaches can aggregate evidence and extract insights for science-based decisions.

The second step is delivering a risk-based approach capable to help you identify, quantify, and prioritize risks, enabling the formulation of risk mitigation strategies. And, at the same time, assessing quality and linking operations to patient outcomes.

Our work with Cell and Gene Therapy companies across these areas has been supported by our partner Cytiva,with whom we developed QRM workflow and tools for each of them.

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Working with us will yield results

Our team's solid expertise in Quality Risk Management in the Pharmaceutical industry was crucial for building this service. When you work with us, you will have:

  • A full mapping of the risks associated to CGT process as well as a monitoring and control plan to make sure they do not escalate
  • Risk Assessments that support your Quality by Design Framework
  • An accurate risk and process history based on one of the best Risk Management platforms
  • Data connected and compared across your whole organization, not just your facility or department
  • Absolute control over the creation of your Risk Management workflows but supported by templates to assure consistency
  • Tools to make informed choices about compared risks and a solid basis to support your decision-making 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.

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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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Bring high quality Risk Managment to your Cell & Gene Therapy processes!