Cell & Advanced Therapies

Delivering robust, commercially-focused manufacturing for next-generation therapeutics

The 2017 FDA approvals of the ground-breaking CAR-T therapies from Novartis (Kymriah) and Kite Pharma (Yescarta) were major milestones for the cell and advanced therapy industry. Both therapies target relatively small patient populations, and despite their demonstrated efficacy carry price points that will become unsustainable to healthcare systems as this therapy class emerges broadly. As the industry looks to address larger disease indications, there are critical challenges around the effective manufacturability of cell and advanced therapies that need to be addressed.

Answering Market
Challenges

The success of cell and advanced therapies relies on consistently delivering a quality product at an acceptable cost. Drivers of these are embedded relatively early in the clinical development process, making it important to define and manage to a commercial vision from the early clinical stages.

Path to commercial production
Product quality & reproducibility
Manufacturability at an acceptable cost

Path to commercial production

Balancing the combined risks of a non-linear therapy development pathway, funding limitations, clinical trial milestones and scarcity of skilled personnel requires the right amount of attention to commercial manufacturing considerations. During the strategic planning and feasibility stage of our process, we will define a detailed and achievable manufacturing establishment 

roadmap to support your commercialization plan. This provides a viable concept of how the product will be manufactured at commercial-scale and the path to reaching that point. This demonstrable path to commercial production becomes a valuable fundraising tool, driving structured investment aligned with the progression of clinical manufacturing needs.

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Product quality & reproducibility

Commercial supply of cell and advanced therapies requires consistent product quality. That typically means a considered transition from open, manual processing to closed, automated production. Beginning with a deep understanding of our client’s process, we take a carefully structured approach to demonstrating performance capability for each unit operation before combining proven elements to configure a manufacturing solution meeting process needs. 

The elimination of variability in a mature process drives consistent product quality through the removal of skill-based operations and advanced, repeatable control over all process variables. 

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Manufacturability at an acceptable cost

Beyond efficacy, therapy production cost becomes the major driver of commercial success—perhaps more than any previous field of medicine. The right solution is rarely to automate everything.

Our ‘whole-of-system’ approach typically combines our configurable modules, the best existing technologies on the market, our global network of leading partner organizations, and our powerful ability to produce tailored/custom solutions where gaps exist.

Our ability to integrate the best of each aspect delivers scalable, cost-effective therapy manufacturing.

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Path to commercial production

Balancing the combined risks of a non-linear therapy development pathway, funding limitations, clinical trial milestones and scarcity of skilled personnel requires the right amount of attention to commercial manufacturing considerations. During the strategic planning and feasibility stage of our process, we will define a detailed and achievable manufacturing establishment 

roadmap to support your commercialization plan. This provides a viable concept of how the product will be manufactured at commercial-scale and the path to reaching that point. This demonstrable path to commercial production becomes a valuable fundraising tool, driving structured investment aligned with the progression of clinical manufacturing needs.

img

Product quality & reproducibility

Commercial supply of cell and advanced therapies requires consistent product quality. That typically means a considered transition from open, manual processing to closed, automated production. Beginning with a deep understanding of our client’s process, we take a carefully structured approach to demonstrating performance capability for each unit operation before combining proven elements to configure a manufacturing solution meeting process needs. 

The elimination of variability in a mature process drives consistent product quality through the removal of skill-based operations and advanced, repeatable control over all process variables. 

img

Manufacturability at an acceptable cost

Beyond efficacy, therapy production cost becomes the major driver of commercial success—perhaps more than any previous field of medicine. The right solution is rarely to automate everything.

Our ‘whole-of-system’ approach typically combines our configurable modules, the best existing technologies on the market, our global network of leading partner organizations, and our powerful ability to produce tailored/custom solutions where gaps exist.

Our ability to integrate the best of each aspect delivers scalable, cost-effective therapy manufacturing.

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Our Process

For over 15 years, we have helped cell and advanced therapy companies transition from open, manual processes to closed, automated GMP manufacturing. We have an intimate understanding of the market, and a proven process for developing and implementing a viable plan for progressing your cell-based therapy from the clinic to commercial-scale manufacturing.

Cell & Advanced Therapy Clients

Invetech was the first company to develop a closed manufacturing line specifically for the commercialization of a cell therapy, and have since supported more than 50 clients worldwide.

Case Studies

We deliver commercial value to our clients, solving their toughest challenges through application of our industry expertise and managed innovation processes.

Also Check Out

Below is a selection of our most recent cell therapy articles, resources and insights.

Let’s work together

Our scientists, engineers, designers and program managers know what it takes to make your cell or advanced therapy a success.