Category: Innovation Infrastructure
How Leiden provides the right stepping stones for cell therapy businesses to hit the market and scale up
With its decades of heritage as a pioneer in cell therapy research, Leiden University Medical Center (LUMC) has been an important promotor of the technology and a magnet for leading experts from around the globe, eager to contribute to getting these break-through therapies to patients.
In cell therapy, a subfield of regenerative medicine, stem cells are extracted and manipulated to execute a task, e.g. transplanted T-cells that are programmed to attack tumor cells, or cells that are programmed to grow into human tissue. The field is very promising but because of the high complexity, laborious process and resulting high costs, cell therapies are currently only used as a last resort. Further development of cell therapy is therefore paramount, calling for investments and collaborative innovation.
The high density of world-leading researchers at Leiden University and LUMC as well as exploration, production and training facilities, startups and multinationals, combined with ample business excellence support and a supportive government at Leiden Bio Science Park make up the ideal components for cell therapy to reach commercial viability and treat patients around the globe. As a result, Leiden holds an indispensable position in the global quest for expanding the range of commercially viable cell therapy solutions.
A Central position in the global quest for cell therapies
In December 2021, the regions’ position was again reenforced when Leiden University Medical Center (LUMC) announced that it had received a EUR 300 million investment from Novo Nordisk Foundation to form a new international cell therapy consortium Novo Nordisk Foundation Center for Stem Cell Medicine reNEW. This consortium brings together LUMC and its spin-off Netherlands Center for the Clinical Advancement of Stem Cell & Gene Therapies (NecstGen), the DanStem Institute at the University of Copenhagen and the Murdoch Children’s Research Institute in Melbourne. The cell therapy consortium reNEW will collaborate to get fundamental discoveries translated into stem cell medicine.
Business-oriented facilities are key to advancing cell therapy
NecstGen, the incubator facility for clinical advancement of Stem Cell and Gene Therapies, was established in 2020 to further support valorisation of innovative cell therapy breakthroughs. This non-profit spin-out from LUMC provides cleanroom facilities and services that are tailored to the needs of early-stage startups in their exploration of viable use-cases for their innovative cell therapies and for scaling the manufacture of their treatments. The center is open to the foreign and Dutch academic, small, and large industrial therapy developers to translate research and early-stage clinical programs into treatments for patients. It provides cleanroom facilities and services that are tailored to the needs of companies in their exploration of viable use cases for their innovative therapies and for scaling up the manufacture of their treatments.
Paul Bilars, CEO at NecstGen: “We established NecstGen because we felt the urgency to facilitate researchers with getting their innovative cell therapies to the market. Many of them have the potential to bring treatments to patients with conditions that are currently untreatable. But that can only happen if they are developed according to strict regulations into a clinical-phase product.”
With access to researchers from Leiden University and LUMC for clinical trials, NecstGen can play an important role in helping companies and academia to get their cell therapies from the lab to the patient, a highly complex process that requires a wide range of expertise and investments to successfully accomplish.
“With our cleanrooms and experienced staff with in depth knowledge of cell and gene therapies we will be able to accelerate the translation of early stage programs into actual therapies for patients”, says Paul Bilars.
The range of services and activities provided by NecstGen and its position in the greater life sciences ecosystem in the Leiden region, form an attractive proposition for international cell therapy companies to develop and grow their business here.
“We are very internationally oriented and welcome starting companies and research groups from all over the world to join us here. The accumulated knowledge and facilities available here create a great environment for companies to develop and grow their business”, Paul explains.
The NecstGen facilities are set up according to internationally acknowledged quality standards, aligned with EMA and FDA, allowing development & manufacture at a scale that is fit for clinical trials. Focused on (small) emerging companies and academic groups, the multidisciplinary NecstGen team provides services such as translating research protocols into gmp protocols, manufacture and compliance.
On the business side, the cell therapy community at Leiden Bio Science Park was recently strengthened by the establishment of the first European cell therapy manufacturing facility of Bristol Myers Squibb. From this large-scale manufacturing site, BMS will supply European patients suffering from blood cancers. Within a few years, 200 professionals will be employed at this site.
“This region offers many advantages for our production facilities. Not only because of the good reputation of LBSP and the knowledge and talent that is present here; also because of the excellent logistics both at Schiphol and in the port of Rotterdam”, explains Arjen Schippers, Senior Director and Program Head of Europe Cell Therapy Facility about BMS’ choice for Leiden.
Good logistics are a precondition for successfully offering cell therapies. Blood samples must first be cooled with fluid nitrogen, brought to the production facility at -150 degrees, and then returned to the hospital under the same conditions. The central location in Europe and the good infrastructure in Zuid-Holland make transport to and from patients throughout Europe many days faster than is currently the case, so that treatment is possible in the shortest possible time frame.
As cell and gene therapies are still a relatively young treatment area, given that they have only been approved by EMA for the European market since 2020, there are still many opportunities for expanding its potential application areas and for optimising its production processes.
“Most providers of cell therapies, including BMS, currently target blood cancers. This has to do with the fact that these are the most accessible type of cancer for these therapies, which makes it a good entry point from which to expand research and to combat increasingly complex forms of cancer based on new insights. In doing so, we benefit from the very extensive knowledge that BMS possesses in the field of oncology.” said Arjen Schippers.“Due to the limited side effects relative to other cancer treatments and the promising results in terms of effectiveness, I see a real chance that cell therapies will gain a greater share as a cancer treatment and that this will increase the well-being of cancer patients. It is much too early to draw firm conclusions about this, but the potential is certainly there,” he explains.
In addition to extending cell therapies to other forms of cancer, there is also potential in optimizing current production. Arjen: “In the best case scenario, we will be able to work towards a situation in which we no longer use the patient’s own cells, but grow general programmed CAR T cells that are suitable for a large group of patients. This would have far-reaching consequences for the processing time. This would boost the accessibility of these treatments to patients around the world.”
Getting production up and running
At the end of October 2021, the first pile of BMS’ new production facility was driven into the ground and production at the factory is to start in the summer of 2023. Until then, BMS will operate from a temporary office and laboratory at the Leiden Bio Science Park.
“When we open the factory, all 200 people must already have been hired and trained. We cannot afford to start doing that in a year and a half.” Arjen explains. “We have therefore already been in contact with various relevant educational institutions and study associations to announce that we will start recruiting soon. The presence of potential partners such as the Biotech Training Facility also makes it easier to train lab technicians for our specific technology, and there will be a minor in cell therapy at Leiden University of applied sciences, which will also provide talent that can join us even more easily.”
Arjen and his team are looking forward to an intensive period of construction, start-up and recruitment. “It will be hard work, but I have every confidence that this will succeed and that we will be able to provide European patients with their CAR T cell therapy produced in Leiden in 2024.” Arjen concludes.
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