2021-07-14| Manufacturing

In Quest For Scalability in Cell Therapy Manufacturing, Cellares Partners with Poseida

by Rajaneesh K. Gopinath
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Cell therapy manufacturing tech company, Cellares intends to provide a revolutionary end-to-end manufacturing solution for cell therapies. Fresh off an $82 million Series B funding just two months earlier, the South San Francisco-based startup has now inked a strategic partnership to advance its technology further.

On July 14th, Cellares announced partnering with cell and gene therapy company Poseida Therapeutics to receive performance data and written feedback for its Cell Shuttle, a fully closed and automated cell therapy manufacturing platform.

“We’re thrilled to have Poseida Therapeutics on board to help broaden the possibilities for our Cell Shuttle platform,” said Fabian Gerlinghaus, Co-Founder and CEO of Cellares.

“Poseida’s tremendous expertise in the cell therapy space, especially spanning a diverse range of therapeutic modalities, is a huge boon to our developmental efforts. We anticipate our work with Poseida to demonstrate the Cell Shuttle’s adaptability for multiple cell therapy modalities, particularly CAR-T cells,” he said in a statement.

Cellares forges partnerships through its Early Access Partnership Program (EAPP), an initiative taken to ensure product-market fit. After PACT Pharma and the Fred Hutchinson Cancer Research Center, Poseida is now the third organization to participate in Cellares’ EAPP.


Drawbacks of Manual Manufacturing Methods

Speaking to GeneOnline, CEO Fabian Gerlinghaus explained that cell therapy manufacturing poses a unique problem as the goal is to produce personalized therapies for one patient at a time (autologous) or making a small batch for a few hundred patients (allogeneic).

“With personalized medicine, it is incredibly difficult to scale. The challenge of scale is new, and it arose in 2017 when Kymriah and Yescarta won market approvals as the first two CAR-T cell therapies,” he said.

Gerlinghaus argued that the manual methods with which cell therapy companies are manufacturing today simply do not scale. In addition, manual operations, when combined with multiple transfer steps, increase the risk for errors and contamination. As a result, thousands of patients are delayed access to life-saving cell therapies.

“Teams of highly trained scientists are spending a great deal of time and money to produce cell therapies, executing on the order of 50 manual processing steps and around 80 hours of touch time. This involves the use of a plethora of benchtop instruments that weren’t purpose-built for cell therapy manufacturing. Hence, we set out to solve the problem of scalability and thereby accelerate the access to life-saving cell therapies,” he said.


A Next-Generation Cell Therapy Manufacturing Platform

Gerlinghaus described the cell shuttle as a cost-effective, reliable, and, most importantly, a scalable platform. Dubbed as the “cell therapy factory-in-a-box,” the platform consists of consumables, sophisticated instrumentation, and software support in a single automated unit.

“The platform has different layers of protection and is built with redundancy for various instruments. So, if one of them were to go down, we can use software to pause the specific instrument without disrupting the overall process. You could also eject a consumable from one cell shuttle during mid-run and insert it into another,” he said.

The Cell Shuttle (Image courtesy: Cellares Corp.)

The cell shuttle is used by loading the starting material inside a single-use “GMP-in-a-Box” cartridge. The all-in-one cartridge contains necessary consumables and is designed as a closed system to mitigate the risk of process failure and contamination. It supports all processing steps, from loading the starting material to unloading a cell therapy product ready for infusion.

The cell shuttle is said to enable a three-fold reduction in process failure rates compared to existing cell therapy manufacturing methods. Besides, it can produce 10+ patient doses in parallel, which increases manufacturing scalability by an order of magnitude. It also minimizes the per-patient manufacturing cost of most processes by 70%.


“A Good Collaboration”

Speaking of the partnership, Mark J. Gergen, President and Chief Business Officer of Poseida, told GeneOnline that it would be a good collaboration where Cellares brings the technology and Poseida brings the cell therapy.

“Cellares is taking an ambitious approach to fully automate the process of cell therapy manufacturing and make it more robust. Their initial focus is on our autologous candidates, although we will be working with them on our allogeneic programs as well,” he said.

Mark J. Gergen, President and Chief Business Officer of Poseida Therapeutics

Poseida currently has two autologous CAR-T candidates in the clinic, P-BCMA-101, for patients with relapsed/refractory multiple myeloma and P-PSMA-101, for patients with metastatic castrate-resistant prostate cancer. In addition, the company is also developing P-BCMA-ALLO1, its first allogeneic CAR-T product candidate targeting BCMA to treat r/r multiple myeloma.

Gergen stressed that it’s always been their goal to move into allogeneic products. Therefore, they have incorporated their learnings from their autologous program into the allogeneic program and anticipate an IND filing for P-BCMA-ALLO1 soon.

“The flexibility of the Cell Shuttle matches the breadth of approaches we are developing at Poseida,” said Kerry Ingalls, Chief Operating Officer at Poseida, in a statement.

“To work across our cell therapy portfolio, an automated manufacturing system should be capable of reliably producing a range of therapies autologous and allogeneic CAR-T and in both solid and hematological cancers, for research and at scale for clinical trials and, ultimately, commercial applications. By joining forces with Cellares, we believe we can leverage the Cell Shuttle’s capabilities to help support our overall manufacturing strategy, further advancing cell therapy manufacturing.”

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