From Innovation to Impact: Digital Transformation in Cell Therapy Manufacturing with Narinder Singh, CTO of Arcellx [Speaker Spotlight]

In the rapidly evolving field of cell therapy, innovation is not just about groundbreaking science—it’s about scaling life-saving treatments efficiently and reliably. Digital transformation and automation are revolutionizing how these therapies are developed, manufactured, and delivered to patients.

In this speaker spotlight interview, Narinder Singh, Chief Technical Officer at Arcellx, shares insights on transforming cell therapy in the digital age. Gain key insights into overcoming automation hurdles and leveraging advanced technology for innovation before his sessions at the 11th Annual American Biomanufacturing Summit!

Can you introduce yourself and share more about your career journey leading up to your current role as the chief technical officer at Arcellx?

It's my pleasure to be here, and thank you for this opportunity.

A bit about myself: I'm a biochemical engineer by training and have been in the biotech industry for about 28 years now. Most of my experience has been in taking products from early to late-stage and to commercialization, and most of my career has been in biotech and for biological products.

After 18 years at Amgen, I worked at several mid- to small-scale biotechs in a variety of executive roles, and my first role in cell therapy was about seven years ago. I came to learn about Arcellx in the fall of 2021 and was immediately mesmerized by the company, its technology, and the data that was emerging. I was also most impressed by the executive team because it was new and filled with energy and I wanted to be part of it.

Briefly about the company—Arcellx has developed a novel technology called the D-Domain, which is a simple, fully synthetic binding domain used for target binding purposes. The company has leveraged this technology to develop CAR-T therapies.

Our lead product candidate, anito-cel, is currently being investigated for relapsed and/or refractory multiple myeloma in a Phase 2 registrational trial, iMMagine-1, and an earlier line Phase 3 trial called iMMagine-3. We recently presented positive data for the iMMagine-1 study at the ASH meeting last December, which we’re very excited about.

In December 2022, Arcellx and Kite Pharma, a Gilead Company, entered into a strategic collaboration to co-develop and co-commercialize anito-cel in multiple myeloma. The companies are preparing for the 2026 commercial launch of anito-cel in multiple myeloma! 

What are the latest advancements in automation technologies that are impacting cell therapy?

I truly am fortunate to be part of this.

Automation for manufacturing operations is around in almost any modern manufacturing industry. 

Cell therapy is a little bit different because we're talking about live human cells that are engineered into therapies that can potentially cure people, with just a single dose. This is highly innovative yet very challenging because you're talking about handling live cells which are different from patient to patient. Scaling manufacturing for these therapies so that they can be as widely available as possible is perhaps one of most pressing needs for these therapies.

When this industry started, early CAR-T product manufacturing success rates were pretty low. It doesn’t help anyone—especially patients—if a potentially life-saving therapy that could even cure their disease cannot be manufactured or made available to them. That’s why I believe automation can make a significant difference in cell therapy.

We are quite excited about automated cell selection and culture technologies, a way to completely close the process. Because we are dealing with live cells, you can't sterilize them by heating them or irradiating them, so you have to completely handle them aseptically with minimal human interventions.

Now we even see some additional integration emerging around fill and finish, which I'm pretty excited about. In addition to the manufacturing technologies, analytics are the key. It's not just manufacturing but how you test the product and there are a lot of interesting analytics emerging with full automation that can dramatically change how cell therapies will be manufactured.

“The goal of any automation is to reduce operator variability, reduce errors, reduce contamination risk, improve quality, and thereby substantially increase scalability”. 

What challenges have you personally faced when integrating automation into production, and how did you overcome them?

First of all, we're incredibly fortunate to have built an exceptional team. I'm really proud of my Tech Ops team, our MSAT, Process Development, Analytical Development and Supply Chain teams, as well as how seamlessly they collaborate with our Quality / Regulatory teams to make this all work.

Delivering cell therapies truly takes a village. One of the hurdles with CAR-T therapies is that they were originally developed using cell expansion protocols that are highly manual.

While that approach works in a lab setting with non-human subjects, scaling it for broader applications is key. It is also really important that CAR-T manufacturers don't automate or improve a process for the sake of automation or improvement.

“How do you make something that can work across different diseases, that can work across different antigens, while still remaining a stable, scalable process?”

How do you ensure the accuracy and reliability of data collected from bio trackers?

Many of these trackers and analytical methods were originally developed for lab use and transitioning them into a GMP environment can been complex.

Data also needs to be compliant with CFR Part 11, the FDA regulation governing electronic records, and signatures. 

We strive to implement analytical equipment and tracking systems that are both accurate and reliable. In cases where certain tools are not fully Part 11 compliant by design, we take steps to qualify them to ensure they meet these standards.

What are the key indicators that a biomanufacturing operation has reached digital maturity?

First, it’s important to note that we shouldn’t put the cart before the horse and automate just because we can—it needs to deliver real value to the patients and the company.

Digital maturity is reached when a process can be broken down into well-designed, simplified operational flows that can be reliably executed through automation. If a process is poorly designed and you attempt to automate it, you're likely to replicate the existing problems rather than solve them. Automation isn’t yet capable of handling that level of complexity effectively.

Additionally, you need to select and integrate process elements—unit operations and technology components—that are compatible with automation. For example, the cell selection technology, analytics, and equipment used for growing and formulating cells must be able to communicate seamlessly with automation systems. All these components need to work together.

And finally, there must be a clear business driver. You need clinical proof of a concept before moving forward with automation. You don’t want to implement it too early. Look first for a product that is suitable for automation and a process designed for innovation, then consider how to automate it.

How can digital innovations contribute to the long-term sustainability and efficiency of biomanufacturing?

We’re talking about cell and gene therapies—treatments that hold immense promise.

These therapies can be transformative for patients whose lives are at stake, and in some cases, a single dose could potentially cure them for life.

We’ve all seen stories in cell therapy where doctors face difficult decisions about rationing due to limited supply, having to select patients based on who would benefit most because there are only so many treatment slots available. That’s why the ability to scale these therapies appropriately is absolutely critical.

As we discussed earlier, these are living therapies, and there’s significant variability from patient to patient and across different indications. Even within a single batch, cells may grow in unexpected ways, making process variability a major challenge. In this context, digital innovation is key to achieving scalable production—when the time is right.

For example: when we developed our autologous anito-cel cell therapy, we achieved a nearly 100% success rate in Phase 1 and pivotal clinical trials. While those trials involved smaller patient populations, our well-designed process allowed us to deliver consistently.

We’ve partnered with Kite, a world leader in cell therapy. We’ve been incredibly fortunate to leverage their deep expertise in digital implementation and their world-class manufacturing capabilities. They’ve built a highly integrated, efficient system with rapid turnaround times, and they’ve already delivered life-saving treatments to tens of thousands of patients at a very high success rate.

Given the strong data and early manufacturing success of our therapy, we believe that partnering with Kite to scale production will be invaluable to delivering our novel therapy to the multiple myeloma patients who need them.

What are you most looking forward to about the American Biomanufacturing Summit?

I'm very excited about the American Biomanufacturing Summit – I'm going to be meeting our colleagues from the industry, sharing our own experiences and learning from theirs. This is specifically a great summit because it's a small set of highly aligned and highly interested partners. So I think we're going to get a lot of value for our time invested.

We are looking forward to having Narinder join us for both a fireside chat and a panel discussion at the American Biomanufacturing Summit, taking place April 15-16, 2025 at the Hyatt Regency San Francisco Airport. 

For more information, visit biomanamerica.com