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.
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.
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
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 in establishing 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 risks of incompletely defined systems, will deliver the promise of an industry for agile patient outcomes.
We are sure that following these approaches, your company will be able to deliver consistent patient therapeutic outcomes for 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.
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:
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.