What were the drivers behind Lonza’s Cell and Gene Division's double-digit growth in 2022?

Lonza’s cell and gene division excels in industrializing what comes out of the lab, making a scalable, robust product with consistent safety qualities. We have significant expertise and coverage, with six sites – three of which are in the US in Houston (Texas), Portsmouth (New Hampshire), and Lexington (Massachusetts), alongside three in Singapore, Siena (Italy), and Geleen (Netherlands). While the US remains the epicenter of the worldwide cell and gene market and is critical to our business, we also have the benefit of diversification and capacity across three continents. We offer an end-to-end service for our customers, no matter what stage they are at on the path to commercialization. On the technology side, we are uniquely positioned to leverage tools such as our Nucleofector Technology and our Cocoon Platform to industrialize and scale up the CGT manufacturing processes, and ultimately help our customers to manage risk and cost.

What is unique about Cocoon and Nucleofector?

The Cocoon platform and the 4D Nucleofector system are two of our products that address different manufacturing challenges facing the CGT industry. The Cocoon integrates multiple steps in the CGT manufacturing workflow. Bringing automation to this space will reduce costs and provide therapy developers with scalable manufacturing solutions for their patient-specific therapies. The integration and automation of unit operations also presents opportunities to bring manufacturing closer to patients at the point of care, avoiding costly logistics and long manufacturing turnaround times.

Nucleofector Technology was introduced as the first efficient non-viral transfection method for primary cells and hard-to-transfect cell lines. It allows for high transfection performance. We own the IP for this technology and as the field looks for alternatives to viral transduction, Nucleofector is well-positioned to support innovators in non-viral gene editing. We also developed MODA-MES for cell and gene therapies. This next-generation platform allows for electronic batch record execution and enables parallel processing with track and trace capability, which in turn can maximize cell and gene production capacity. Across our technologies, we aim to use digitalization to manufacture novel therapies in a compliant and robust manner.

Cell and gene therapies span a wide range of modalities, do you see any areas you forecast driving future demand?

This emerging field presents perhaps the biggest hope in life sciences, as it can treat many indications such as cancer and genetic disorders effectively – and in some cases even have the potential to be curative. Since it is a relatively new technology, it requires lots of expertise in manufacturing novel modalities, whether it is in the autologous, allogeneic, or viral vector fields.

Developing processes that are commercially viable and appropriate for robust manufacturing is probably the biggest challenge the industry faces right now. We saw that in the first cell and gene products that were brought to market, and how difficult it was to get the product to the patient in a timely and cost-effective way.

How do you assess the current regulatory environment in the US?

In the past, the regulators were in what could be described as a ‘catch-up mode’ about the emerging field of cell and gene. This has changed, and regulators have put lots of effort into keeping up with the pace of innovation in technology and science. There is a high curiosity for cell and gene therapies from the regulators, and in the fields of point-of-care, distribution, and manufacturing, they show great support for developers and manufacturers. In consultation with key life sciences stakeholders, the FDA updated PDUFA VII in 2022, which will directly support the development and review of CGT products and should help spur innovation across the industry.

What will be the divisions’ priorities in the next 12 to 24 months?

Our cell and gene division will continue investing in tools and platforms to increase productivity and work on compliant and affordable technologies that evolve with regulatory guidelines. Ultimately, we want to help give patients the best access to the amazing technology and treatments being developed by cell and gene therapy innovators. I truly believe that this is the modality with the greatest potential in the healthcare industry today.