Multiply and Stanford Labs look to bring automation to CGTs

Under the partnership, Multiply Labs will use its robotics technology to operate instruments, consumables, and reagents deployed for cell and gene therapy (CGT) manufacturing.

LCGM’s aim is to bridge the ‘bench to bedside’ gap for the patients by developing manufacturing platforms for CGTs, this aligns with Multiply Labs’ focus on scaling availability of these therapies through automation.

According to the firm, this partnership is an endeavor to see “what’s possible with technology.” The financials of this partnership were not disclosed.

BioProcess Insider spoke to Fred Parietti, CEO of Multiply Labs, about this partnership, and the impact of automation on the industry.

BioProcess Insider (BPI): What does this partnership between Multiply Labs and LCGM entail?

Fred Parietti (FP): Multiply Labs in collaboration with the Stanford LCGM, will deploy our latest-generation robotic systems for the manufacturing of cell therapies. Together with the Stanford LCGM, Multiply Labs will compare the performance of automated and manual cell therapy processes. The goal is to show that the performance of automated cell therapy manufacturing is equivalent to the manual processes.

In addition, Multiply Labs and LCGM also aim to demonstrate efficiency improvements, superior quality, and increased throughput enabled by this robotic technology.

BPI: What challenges do cell therapy organizations currently face in adopting automation technology, and how does this collaboration address them?

FP: Pharmaceutical companies are looking for automation to increase efficiency, increase throughput, and increase process quality. This initiative provides a way for both established pharma companies and upstart biotech companies to see the full potential of Multiply Labs’ automation technology by piloting it in collaboration with a world-leading scientific institution like the Stanford LCGM.

BPI: How does Multiply Labs envision increasing adoption of automation among cell therapy organizations through this collaboration?

FP: Multiply Labs and the Stanford LCGM are providing cell therapy organizations with the ideal platform to test the automation of their manufacturing processes. By accessing the combined robotics and scientific expertise of Multiply Labs and LCGM, cell therapy organizations can rapidly test next-generation automated processes and compare them with their original manual processes. Doing so, cell therapy organizations can verify the full potential of applying automation to cell therapy manufacturing, and its quality, throughput and efficiency benefits.

BPI: What are the long-term goals of Multiply Labs and Stanford Medicine's LCGM in advancing automation technology for cell therapy manufacturing?

FP: Demonstrating the potential and the benefits of applying next-generation robotic technology to the development and manufacturing of life-saving cell therapies. Ultimately, our shared goal is to enable the development and approval of more cell therapies, faster. And once these cell therapies are approved, our goal is to enable them to reach all the patients who need them — at an industrial scale and affordably.

BPI: How is the collaboration organized?

FP: The robots will be deployed in a process development (PD) facility in Palo Alto, California. Leading cell therapy organizations (i.e. both established pharma companies and upstart biotech startups) will be able to join the collaboration and run their manual cell therapy processes side-by-side with the equivalent automated processes. Therefore, cell therapy organizations will be able to evaluate our automation technology and its performance in a world-class scientific context.

BPI: This collaboration provides a platform where a customer can run a pilot, but what are the benefits of this for a customer?

FP: A typical pilot project compares the performance of an automated cell therapy manufacturing process with the corresponding manual process. The Multiply/LCGM collaboration enables these pilots. When a cell therapy organization establishes a pilot with Multiply/LCGM they get to verify the performance and benefits of our automation technology applied to their cell therapy manufacturing processes.

In particular: The first goal of the pilots is to compare, side-by-side, the automated and manual processes, showing that they are equivalent. In addition, the pilots are designed to show automation’s potential in reducing costs, increasing throughput, and decreasing variability and quality errors.

BPI: How do Multiply Labs' robotic systems facilitate the integration of instruments from multiple vendors in cell therapy manufacturing?

FP: The manual end-to-end processes being used today for the GMP-compliant manufacturing of approved cell therapies are composed of different unit operations. Each unit operation is done by an instrument validated for use in GMP. Multiply Labs collaborated with the leading manufacturers of the instruments, consumables and reagents that are used in the GMP manufacturing of cell therapies.

Our shared goal is to develop technologies that enable Multiply Labs’ robotic systems to autonomously operate the leading cell therapy manufacturing instruments. A key requirement is that Multiply Labs’ robots automate market-leading instruments without modifying them, so that the robotic cell therapy manufacturing process is as close as possible to the original manual process.

BPI: Could you elaborate on how this collaboration aims to bridge the "bench to bedside" gap for patients with unmet medical needs?

FP: Currently there is a huge manufacturing bottleneck for cell therapies. According to some estimates, less than 10% of patients in need can today access cell therapies (this is even worse outside of the US). Additionally, cell therapies are extremely expensive. Finally, cell therapies (like most drugs) take years to develop, and their manufacturing processes are particularly slow to scale because they are so manual.

The use of robotic systems has the potential to dramatically accelerate the development of life-saving cell therapies. Multiply Labs and the Stanford LCGM are excited to collaborate to explore and demonstrate the true potential of automation to discover and manufacture more cell therapies, faster and more efficiently.

BPI: What insights can be gained from the side-by-side comparison of manual and automated processes using Multiply Labs' robotic system?

FP: There are four types of insights that can be gained from the comparison of robotic and manual cell therapy manufacturing processes using Multiply Labs’ technology:

Process insights: to demonstrate the statistical equivalence between the original manual process and the automated (robotic) process that is replicating it.

Efficiency insights: to show that robotic systems are more efficient than manual processes.

Throughput insights: robotic systems are designed to dramatically increase the throughput of cell therapy processes. This is achieved by running multiple processes in parallel.

Quality insights: robotic systems usually lead to reduced process variability, and to a reduced number of quality errors. This increases the robustness, predictability and quality of the manufacturing process.