Cell & Advanced Therapies
Since 2004, Invetech’s Cell Therapy Group has helped realize clinical and commercial-scale cGMP manufacturing solutions for more than 25 cell and advanced therapy companies across the globe.
We leverage our vast experience and deep understanding of the regenerative medicine market, as well as the unique technology and business challenges our clients’ face, to design and deliver optimal cGMP manufacturing solutions that integrate off-the-shelf equipment and custom systems when needed.
Finding the Optimal Manufacturing Solution
We have designed, integrated and delivered manufacturing solutions for regenerative medicine and advanced therapies, including:
- Cell-based immunotherapies
- Gene therapies
- Stem cell and progenitor cell-based therapies
- Primary cell-based therapies
Whether you’re developing an autologous CAR-T therapy to cure cancer, an allogeneic therapy for regenerative medicine, or a bioreactor for tissue production – we will work collaboratively with your team to fully understand the therapy and current process. This understanding enables us to propose cGMP manufacturing solutions that will not impact the therapy or fundamentally alter the current process.
We then develop a plan to successfully transition from the clinic to commercial-scale, and deliver scalable solutions that will ensure a consistent, repeatable product while also managing costs of goods and minimizing total cost of treatment
Help enable a clear path to fundraising, regulatory approval and commercial success
Having completed over 35 projects for more than 25 cell and advanced therapy companies, we have the experience required to help develop a plan to successfully transition from clinical trials to commercial-scale production. Having a credible plan developed by an experienced partner will make it easier to raise funds, meet major milestones, and achieve regulatory approval.
Save time and money by leveraging and integrating off-the-shelf modular solutions
We deliver a complete cGMP manufacturing solution that best suits the needs of our clients. This includes leveraging modular equipment we have developed internally for common unit processes, as well as identifying and integrating off-the-shelf technologies available in the market.
For example, we can leverage modular equipment we have developed for cell washing and concentration, and closed formulation and mixing. Or we can integrate off-the-shelf technologies such as the GE Wave for cell expansion, or closed bag filling for managing your working cell bank.
By integrating off-the-shelf modular solutions, we save our clients’ time and money; however, by also building custom manufacturing systems when needed, we can deliver a complete cGMP manufacturing solution that fits the complexity of the unique therapy and manufacturing process.
After defining the commercial-scale system and critical process technologies, we deploy a staged development and implementation strategy that aligns with our clients’ clinical trials schedule and availability of funding. Our scalable approach helps minimize costs—and risk—while also enabling production capacity to be rapidly increased once the therapy is approved.
Reduce risk, maintain product quality, and ensure consistent repeatable product
We work collaboratively with our clients to develop and refine their manufacturing processes to be robust and error-proof. This includes automating manual laboratory processes to eliminate human error, optimizing unit process workflows, and utilizing closed disposables to enable aseptic processing—all to achieve consistent and repeatable product required for regulatory approval.
Reduce costs by transitioning from a manual process to a closed automated process
Our cGMP manufacturing solutions deliver significant advantages in terms of scalability, reduced cost of therapy, and product quality; however, the most significant cost savings are achieved through the reduction in labor and facility requirements of a closed automated process.
Moving to a closed process using single-use disposables allows significant savings on clean room costs – reducing the total amount of space required, as well as enabling the process to move into lower-grade clean room space which is far less expensive.
Furthermore, automation allows the development of a more repeatable and reliable process which will minimize labor requirements—including the number of personnel required and their level of education—resulting in reduced labor, training and recruitment costs.
To give you a general idea of the cost savings that can be achieved, the graph below shows the scale-up of an autologous therapy and what happens to the cost per patient for three process scenarios: manual and open, automated closed unit processes, and automated closed and integrated. As you can see, there is a significant savings—greater than $105M (USD)—when using single-use disposables as part of a complete cGMP manufacturing solution.
Further breakdown shows that the key cost drivers are remarkably consistent across the three process scenarios; however, through the combination of closed processing, process optimization and automation, a significant reduction in costs can be achieved.
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