“Don’t mind the mess, we’re still setting up,” apologizes Paul Bilars as he walks between a row of huge wooden crates. “This contains the instruments for our laboratories. We are very happy that they are here because due to the corona crisis there is a great demand for this type of advanced equipment. They cost millions and we had to wait months for the delivery.”
Bilars is the director of NecstGen, a biotechnology factory that aims to provide advanced services to other biotech companies and researchers at the Leiden Bio Science Park. “You can think of clean rooms and laboratories that researchers can rent, and a factory to produce cell and gene therapies under strictly controlled conditions.”
Large biotech companies already have such research and production systems “But these are out of reach for many academics and smaller companies. They are designed for other therapies and high volumes, which you as an individual researcher cannot intervene in. We would like to change that.”
Because that’s what researchers need. Bilars knows from his own practice. Until 2018, he was a manager at LUMC.
“In Leiden, we do very cool research in cell and gene therapy and regenerative medicine. But we noticed that this research is often difficult to get out of the labs and with the patient. One of the main reasons for this is the lack of available production systems. We then suggested to the LUMC management to set up such a facility themselves. And now we are here.”
He points around and says it with a big smile. NecstGen has just completed a small formal opening.
“But that doesn’t mean we’re already running! In the coming months, we will test and install the machines. The research labs will open after the summer, and cleanrooms and production facilities will be inspected in November. If they are then certified according to GMP standards, we can start production early next year.”
The abbreviation GMP stands for ‘Good Manufacturing Practice’. It is a standard that laboratories must meet in order to manufacture drugs or vaccines and ultimately be approved by the health authorities.
Two hundred liters
“At the end of the day, that’s what it’s all about. Getting the promising research from the lab to the patient. We do this first by guiding researchers in translating their academic method into a GMP protocol. In a small laboratory, you can use materials that do not have to meet the requirements of GMP, but you have to replace them with approved materials for production.”
“The same applies to the quantities. An initial examination is performed with very small volumes, often milliliters. But if you need ten liters or two hundred liters of gene therapy to start a clinical study, you can’t just multiply those quantities. Raw materials affect each other, and that interaction looks different in larger quantities than in a laboratory dish. We help with that. If all this succeeds, we will start production under controlled conditions.”
NecstGen does this without a profit motive, says Bilars: “We are a company and we have to keep our own pants on. But our goal is to facilitate, not to generate profit.”
The first customers have already arrived. “With Proteonic, a company located here in the Bio Science Park, we will establish the production of viral vectors for gene therapy. And we have been asked to join the European BIOPROS consortium, also for vector production. It is clear that there is a great demand from the market for what we offer. It was a big step for the LUMC board to fund the start of NextGen in 2019, but that vision was the right one. We are really building a missing link.”
Idea: ‘We help researchers and companies translate their research into concrete development and production of cell and gene therapies’
Where: The Mirai House in the Leiden Bio Science Park
WHO: Paul Bilars (46) director and co-initiator
Financing: comes from LUMC and the National Growth Fund, the province of South Holland and the University of Leiden. A total of 30 million euros.
Employee: 35 people