Cellular Origins, which spun out of TTP as an independent technology and product development company in January 2023, has partnered with fill–finish equipment manufacturer 3P innovation to advance cell and gene therapy (CGT) manufacturing.

As per the agreement, the partnership will integrate 3P innovation’s CryoFIL cryovial filling platform within Cellular Origins’ robotic system, Constellation, to automate filling of cryovials within a closed and sterile environment.

According to the firm, technology integration will focus on the development of a system for robotic docking with CryoFIL, allowing the manufacturing processes that require interfacing with vials and other open format containers to be fully automated, maximizing production efficiencies.

The collaboration aims to advance the system’s capabilities, helping customers to alleviate the requirement for manual and problematic process steps in CGT manufacturing that can require significant time and labor investment.

BioProcess Insider spoke to David Johnson, sales and marketing director, 3P innovation, about this partnership, the technology, and its impact on the CGT industry.

BioProcess Insider (BPI): What is the nature of the collaboration between 3P innovation and Cellular Origins in the field of CGT production?

David Johnson (DJ): 3P innovation and Cellular Origins are working together to combine their know-how and technologies to create an automated cell therapy production facility with the goal of enabling scalable and cost-effective manufacture of CGTs by expanding the capabilities of Cellular Origins robotic system Constellation. The partnership sees both businesses contribute engineering and automation expertise and resources to develop this exciting new solution.

BPI: How will the collaboration accelerate the development of fully automated cell therapy manufacturing systems?

DJ: The Constellation platform automates known and currently accepted individual processes, such as CryoFIL, making it easier to initially adopt automation into the CGT-manufacturing psyche and move away from an operator led manufacturing process.

BPI: How does the integration of the CryoFIL platform enhance the manufacturing efficiency of CGTs?

DJ: Traditionally a manual process, integrating the CryoFIL platform enables product samples to be captured in the manufacturing process without introducing an operator into the environment. This is key, because the operator poses the biggest sterility risk to the product. Maintaining the integrity of the samples is critical, because they are used for QC purposes and product release.

BPI: What role does cGMP compliance play in ensuring the reliability of the integrated Constellation and cryoFIL platform for large-scale CGT production?

DJ: In any pharmaceutical manufacturing process, repeatability and measurement of Critical Quality Attributes (CQAs) are essential in producing a quality product. The Constellation platform with CryoFIL enables real-time measurement of various CQAs. The automation of this data is important in the fast release and approval of the drug product, ever more so with CGTs which are often time-critical personalized therapies with a patient waiting in a hospital bed for the product to be administered.

BPI: How does this partnership address the broader industry challenge of reducing the costs of CGT manufacturing?

DJ: Building on the synergies each company brings to the table, we see this collaboration as a model to move the industry forward. There are many companies and individuals within the CGT space with incredible knowledge that are doing amazing things with cells, DNA, and other starting material. There are other companies that have huge amounts of experience in getting products to market and manufacturing them in a compliant manner while meeting patient demand and driving down production costs. Through collaboration, we can combine the associated strengths of various bodies and address the biggest challenges. If we needed a test case to demonstrate that such accomplishments can be done at speed, then the recent experience in producing a vaccine for COVID-19 in a little over a year should address any doubts about the viability and value of collaboration.

BPI: What specific challenges in the current CGT manufacturing process does this automated system address?

DJ: Current processes are very labor intensive and there is simply not enough trained operations or cleanroom space available to scale the process. Our modular approach enables automation to be applied where it will have the biggest impact in the manufacturing chain without having to invest in large-scale automation solutions that can be financially prohibitive for products in the early stages of their life cycle. By introducing modular automation, it also facilitates the softer adoption of a new approach into what is a risk averse industry.

BPI: In what ways will this collaboration improve the accessibility of CGTs to a larger patient population, as suggested by the leaders of both companies?

DJ: One of the main barriers to access is the costs of therapies, which are driven by the time it takes to produce drugs. Drug production is very labor intensive and requires a lot of expensive cleanroom space. Current models indicate 30x more products can be produced in the same footprint with a 16x reduction in the workforce. The cost reductions achievable on these predictions are clear and should make treatments more affordable. The other element automation provides, which we see in other industries, is the potential to run 24/7 to ensure there is always production capacity in the system. This will reduce waiting times and prevent any bottlenecks, therefore enabling therapy producers to treat more patients in less time.