• Pages
  • Editions
01 Cover
02 Welcome Letter / Sections
03 Section 1: Introduction
04 Introduction to USA Life Sciences Industry
05 Janssen Interview
06 Etihad Cargo Interview
07 UPS Healthcare Interview
08 The Investment Climate
09 MPM | BioImpact Capital Interview
10 Industry Insights: Promising Forecasts for Consolidation and M&As
11 The Regulatory Landscape
12 Porzio Life Sciences Interview
13 PBOA Interview
14 EY USA Interview
15 LaVoieHealthScience Interview
16 Section 2: Established and Emerging Hubs
17 Map of US-based life sciences companies interviewed
18 The East and the West
19 BioNJ Interview
20 MassBio Interview
21 Biocom California Interview
22 PABC Interview
23 Growing Life Sciences Hubs
24 JLL Interview
25 Industry Insights: From Ivory Towers to Incubators
26 Section 3: Drug Discovery and Development
27 Drug Discovery and Development
28 Sangamo Therapeutics Interview
29 PsychoGenics Interview
30 Aphios Corporation Interview
31 Industry Insights: Biotechs Fairing in 2023
32 Ymmunobio Interview
33 Section 4: Contract Manufacturing, Services and Chemicals
34 The Industry's Growing Reliance on CDMOs
35 Pfizer CentreOne Interview
36 CordenPharma International Interview
37 AMPAC Fine Chemicals Interview
38 Adare Pharma Solutions Interview
39 Aenova Group Interview
40 Dipharma Francis Interview
41 Kindeva Drug Delivery Interview
42 Prince Sterilization Services Interview
43 Interbiome Interview
44 Adopting a Proactive Stance
45 Lonza Interview
46 Aragen Life Sciences Interview
47 Industry Insights: Contractors, Manufacturers, and Lab Services
48 Nivagen Pharmaceuticals Interview
49 Chemicals and Service Providers
50 Evonik Health Care Interview
51 Section 5: New Technologies
52 Leveraging AI for Drug Discovery
53 Apprentice.io Interview
54 Technology for Patient Centricity
55 Illumina Interview
56 Section 6: Company Profiles
57 Porzio Life Sciences Company Profile
58 Adare Pharma Solutions Company Profile
59 SK pharmteco Company Profile
60 Article & Interview Directory
61 Credits

Daniel Palmacci President, Cell & Gene Division

LONZA

"We want to give patients the best access to the amazing technology and treatments being developed by cell and gene therapy innovators. This is the modality with the greatest potential in the healthcare industry today."

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.

Next:

Interview: Aragen Life Sciences