Welcome to Cell Forge 1: The Future of Cancer Therapy Manufacturing

Welcome to Cell Forge 1: The Future of Cancer Therapy Manufacturing

Join us for the virtual unveiling of Cell Forge 1, Allogene Therapeutics’ state-of-the-art manufacturing facility. I am proud that it will be where we are forging the future of CAR T therapy.  

I’m a cell biologist who developed a passion for CMC, or chemistry, manufacturing and controls, working in the biotech industry. In a career that has included positions at Amgen and Genentech, and now at the allogeneic cell therapy leader Allogene, I’ve learned firsthand the importance of excellence in manufacturing, and, along with my stellar team, we’ve embedded those lessons learned into Cell Forge 1, a 136,000-square-foot facility designed for clinical manufacturing and potential commercial production.

From “Vial to Vein”

Cell Forge 1 arrives at an important time for Allogene and for cancer patients.

This year, we plan to launch our first pivotal clinical trial, one that could provide the data we need to bring our AlloCAR T™ products to approval.

That will be a huge step for the field.

These product candidates are fundamentally different from the biologics I worked with in my previous roles. They are instead living immune cells, called T cells, transformed by gene editing into therapies that can target tumors in patients’ bodies.

There are only five autologous chimeric antigen receptor T cell (CAR T cell) therapies approved by the U.S. Food and Drug Administration. Each with limitation by nature of the fact that they are “vein to vein” and require a lengthy manufacturing process that can limit access. Allogene, through both our development efforts and CMC work, including what we are doing at Cell Forge 1, is forging the path to create the first CAR T products using cells from healthy donors, or allogeneic cells, rather than cells taken from cancer patients themselves.

This is an important distinction and a critical reason why Cell Forge 1 plays a key strategic role in Allogene’s larger mission.

Allogene’s AlloCAR T products are designed to be standardized medicines, available for all, off-the-shelf. When a cancer patient is in need, their physician will be able to order ready-to-go AlloCAR T product within days – “vial to vein.” For advanced cancer patients, rapid delivery is essential as each day is meaningful to thwart the disease’s swift progression.  

Cleanrooms, natural light and sustainability

To craft living immune cells into approved medicines, we needed a special place. Splashed with natural light, with an integrated and future-focused design, Cell Forge 1 is up for the challenge.  

When the donor cells arrive at the facility, they undergo a processing step and the purified cells are then carefully preserved in cryogenic storage units, where they can be safely stored and readily accessed for future manufacturing runs.  

The cell manufacturing in Cell Forge 1 takes place in a cleanroom, and we have the ability to expand into multiple suites giving us the capability to simultaneously produce different products, such as AlloCAR T cells targeting non-Hodgkin lymphoma, multiple myeloma, renal cell carcinoma and others.  

Allogene values environmental sustainability. Unlike many biotechnology plants that contain giant, stainless steel, 20,000-liter vessels, laced with a network of pipes for steam and cleaning, Cell Forge 1 is entirely electric, and its power sources will include 2,400 solar panels on the roof. We chose green materials when possible, worked to conserve water and energy, optimized indoor air quality and designed the facility with the future in mind.  

Our future orientation is key for our business model as well; cell therapy is still in its infancy and I’m confident we are going to continue to improve and innovate. Cell Forge 1 is ready for that — we built in room for growth, flexibility and adaptability for the substitution of improved technologies over time.  

Cell Forge 1 incorporates significant space for analytical testing. This will allow for speedy feedback for manufacturing and also create standardized, dependable quality control to facilitate regulatory compliance. We’re ready to capture and share the data we gather, allowing for continual learning. There is also space for on-site administrative staff, keeping us organized and equipped.  

One Allogene, together forging a revolution for people with cancer

The people who work here, our team, have always been a key driving factor behind the design. Cell Forge 1 is located in Newark, Calif., part of the bustling Bay Area biotech community, fostering innovation and growth, and near our headquarters in South San Francisco, allowing for strong ties with the research and process development teams. We are truly One Allogene, a team more than 300 strong united by our efforts to create a scientific revolution for individuals with cancer.  

The facility itself empowers collaboration and idea exchanges.  

Windows throughout the facility foster a culture of transparency and close connection to our mission. Employees are able to witness the journey of the cells, from their arrival into the facility, through their transformation and cultivation, to their departure, packed in vials ready to be distributed to make a potential difference in cancer patients’ lives.

This is biology, and I love the challenge — and the sky-high potential — of working with these cells. With Cell Forge 1 online, we believe Allogene is equipped to power through its upcoming pivotal Phase 2 trial to becoming a commercial-stage biotechnology company, providing potentially curative therapies within days to cancer patients in need.

Enjoy an inside look at Cell Forge 1.

 

Cautionary Note on Forward-Looking Statements

This post contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The post may, in some cases, use terms such as "believe," “designed,” "potential," "proposed," "estimate," "anticipate," "expect," "plan," "intend," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the timing and ability to progress AlloCAR T™ trials, including advancing to a pivotal trial, and commercialize any AlloCAR T™ products; the ability to manufacture AlloCAR T™ products generally and at Cell Forge 1; the timing and ability to obtain agreement with the U.S. Food and Drug Administration to use any product candidates manufactured at Cell Forge 1; and the potential benefits of AlloCAR T™ products. Various factors may cause differences between Allogene’s expectations and actual results as discussed in greater detail in Allogene’s filings with the SEC, including without limitation in its Form 10-K for the year ended December 31, 2021. Any forward-looking statements that are made in this post speak only as of the date of this post. Allogene assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this post.

Marc Benz

Vice President, General Manager & Site Operations at Biogen

1y

Impressive, happy for you and the Team!!! Congrats!

Florian Loesch

Sales & Business Development for pharmaceutical lyophilizers in Asia, Latin America, Spain & Portugal

1y

Congratulations Alison and your team.

Ritesh Rathore

Head Projects at Pidilite industries Ltd handling Greenfield and Brownfield projects.

1y

Congratulations

Nate Hughes, MPH, MPP, M. Phil.

Business Development Manager | Life Sciences Services

1y

Fantastic!

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