European Cell and Gene Therapy companies

European Cell and Gene Therapy companies

European Cell & Gene Therapy Companies

European Landscape For Cell & Gene Therapy companies

At NecstGen, we aim to support industry partnerships and growth. And to enable the next generation of therapies, it is pivotal to have oversight of the gene and therapy landscape to start from, which is why we created this helpful tool. Feel free to use and share it, so together, we challenge today’s possibilities and enable the unthinkable.

 

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The biotechnology business is booming around the globe. Increased private equity investments in biotech, global cross continent acquisition deals, and IPOs have risen to record levels. This boom in development will enable the global biotech industry to surpass its older sibling, the pharmaceutical industry, in interest. One area of biotech that holds a particularly great promise to meet patients’ unmet needs is Cell and Gene Therapy. Such therapies defined as ATMPs (Advanced Therapy Medicinal Products) have a substantial therapeutic potential to treat the patients that current treatments may fail. Although their development can be complex, this is not holding back drug developers, innovation continues in leaps and bounds. But where are most Cell and Gene Therapy developers located? This article and map share insights into the ATMP landscape in Europe and the existence of several hubs

Cell & Gene Therapy Companies in the United Kingdom

With three hotspots in the UK, the Britons lead as Europe’s biotech hub for breakthrough life-science start-ups. McKinsey wrote a fascinating report covering how this hub has matured relative to its peers and what lies ahead on its road to playing a leading role in the Cell and Gene Therapy sector globally.

The report based its results on a Biotech Innovation Index, which assessed the biotech sector on discovery, translation, growth capital, and various impact indicators. Although they do not directly target ATMPs in the study, the large hubs you can see on the map here definitely confirm their findings.

In the UK, most Cell and Gene Therapy companies are located in one of these three clusters:

Cell & Gene Therapy Companies in the Netherlands

The Netherlands has several biotech hubs, all connected through a strong infrastructure network despite its size. Its central location in Europe makes it no surprise that EMA relocated its headquarters to Amsterdam following Brexit in 2020. The Netherlands is also home to several knowledge centres with extensive capacity in Cell and Gene Therapies

Investments into the Leiden University Medical Center (LUMC) have accelerated patient access to innovative Cell & Gene Therapies, including stem-cell therapies. NecstGen is a fruit of those investments and supports organizations worldwide to develop novel therapies for patients. In addition, Utrecht is home to the Utrecht Cell Therapy Facility: a hub for ATMP development specialised in Cell and Tissue based therapies.

In the Netherland, most Cell and Gene Therapy companies are located in these clusters:

Cell & Gene Therapy Companies in Switzerland

Switzerland is known for being the home country of pharmaceutical giants Roche and Novartis and many other leading biotech companies. Together, the combined sector contributes over 40% of Swiss exports. Over 300 biotech start-ups are located in the country and specialise in diverse fields such as oncology, antibodies, and orthopaedics. It’s not a surprise that multiple Swiss companies have already worked on advancing their presence in Cell & Gene Therapy.

Novartis opened its Cell and Gene Therapy facility back in 2019, for manufacturing Kymriah. Last month, Cytiva opened its new manufacturing facility in Grens (Link) and served as the base of operations regarding their Cell and Gene Therapy-related operations and a training centre for European customers.

Swiss Biotech companies are located around the following three clusters:

Cell & Gene Therapy Companies in Italy

The Italian biotechnological sector is concentrated around the northern parts of the country. The North-Western part of Italy is where companies specialising in drug development and new therapeutic approaches appear to be located, including for Cell & Gene Therapies.

Italy’s ATMP-specific service provider market ranks third  in Europe. Therefore, it may not also surprise that some of the earliest advanced therapies and four out of seventeen authorised for the European market originate from Italian academic research. Nature published an article on the challenging yet promising future of ATMP development in Italy.

In Italy, most biotech companies specialised in Cell and Gene Therapy are located in Milan and surroundings.

Cell & Gene Therapy Companies in Germany

Even though there is no clear hotspot in which Cell and Gene Therapy-focussed companies are settled in Germany, the sector has seen immense growth. This builds on the underlying strength of Germany in R&D and manufacturing  in Pharma. The country is home to 660 biotech companies with a total of 50,000 employees. Of those 660 companies, many are focused on Cell & Gene Therapy.

In 2021, more than 29 active clinical trials evaluating CAR-modified immune cells took place, most of which involved CAR-T cells. In Germany, over 50 clinical studies have been conducted in Gene Therapy, making Germany a country heavily involved in the development of Cell & Gene Therapies. Nature published an interesting report on the past and future of Gene Therapy in Germany.

The German Cell and Gene Therapy companies are not clustered, but are located all throughout the country, demonstrating the broad strength of innovation locally.

Cell & Gene Therapy Companies in France

Named as one of the best three biotech centres in Europe by McKinsey, France is home to 720 biotech companies with a combined workforce of over 50,000 employees.France has a thriving academic environment, which can be seen from the number of biotech firms backed by academic research, which was forty-six percent iin 2017.

It may come as no surprise that France is one of the leading countries in Cell and Gene Therapy research. The French government and biotech companies invested in Gene Therapy development early on, and it paid off. More than 10-world leading biotech companies and research groups operate from France, such as Genethon. While most companies and institutes involved in Cell and Gene Therapy development, such as Institut Imagine or Institut Vision are located in Paris and its surroundings, there are several other biotech hubs in France.

Cell & Gene Therapy Companies in Sweden

Sweden definitely has the ambition to rank globally as a Cell and Gene Therapies player. They share the aspiration of the countries mentioned above to provide patients with innovative treatments and have even started a program specifically tailored to ATMPs, Vinnova. By following this programme, Sweden aims to be a leader in advanced therapies by 2030!

The complete program involves partners, including research companies, universities, the Swedish Medical Products Agency, patient representatives, and the pharmaceutical industry’s trade association. Therefore, we can consider their combined perspectives and goals the driving force behind the accelerated, developing landscape ATMPs.

We can find a hotspot of ATMP companies located around the Ideon Science Park in Lund

Cell & Gene Therapy Companies in Belgium

Finally, we mention Belgium on our list of hotspots for Cell and Gene Therapy developers. The Belgium biotech industry is thriving, with more than 140 operating biotechs despite its small size. Known for its vivid biotech landscape, Belgium is also developing their share in ATMP development.

Compared to surrounding countries, large companies always favoured Belgium as a country for their manufacturing operations. Shortly, UCB plans to open up a new gene therapy facility in Braine-l’Alleud, and we can expect it to be operational in 2024.

 

Related Questions

Which Cell Therapies are approved?

In these figures, we gathered and visualized overviews of approved ATMPs over the past years for you.

What does the Cell Therapy Development process look like?

From idea to treatment, you’ll face changing requirement and development challenges. View the figure to see how knowledge of the process inversely relates to freedom to make changes to your process.  

Our experts are only a message away to help you understand the impact of any of these aspects and make informed decisions on outsourcing.

We’d be happy to discuss and help you bring cell therapies to patients.

Press Release Opening NecstGen

Press Release Opening NecstGen

Press Release Opening NecstGen

NecstGen announces the opening of its Cell and Gene Therapy Manufacturing and Development facility.

On 1 June 2022, NecstGen’s brand-new GMP manufacturing and development facility for cell and gene therapies has been opened by Henri Lenferink (Mayor of Leiden), in the attendance of Paul Bilars (CEO of NecstGen), Focco Vijselaar (Director General for Enterprise and Innovation at the Ministry of Economic Affairs and Climate Policy), and Pancras Hogendoorn (Dean of the Leiden University Medical Center), as well as representatives from the Province South Holland, RegMed XB, Leiden Bio Science Park and University Leiden. 

During the festive opening event, visitors were able to get a glimpse of the highly controlled cleanrooms, laboratories, and equipment, which will be in full operation soon. NecstGen’s 4,000 m2 facility features 13 cleanrooms and 3 development laboratories supported by labs for quality control, and office space. Here, cell and gene therapy developers from all over the world can develop and produce a next generation of therapies. 

Construction was only started in April 2021 in the right wing of the Mirai House at the Leiden Bio Science Park. In following months, the facility will be furnished and qualified for the release of GMP products. 

Paul Bilars commented “We are excited to contribute to a new era in medicine. With the opening of our new facility, we hope to take an important step in setting up a future-proof healthcare infrastructure that can benefit from the developments in cell and gene therapy. Ultimately, this helps us to get a new generation of therapies faster to the patient.”

About NecstGen

NecstGen is a new centre of excellence for Cell and Gene Therapy, located in a purpose-built GMP facility on the largest bio-cluster in the Netherlands, Leiden Bio Science Park. Here, NecstGen provides critical contract development, manufacturing, and rental services to academic and industrial therapy developers to deliver a new generation of therapies to patients. NecstGen is fully owned by the Leiden University Medical Center and has also obtained support from the National Growth Fund, Province South Holland, and Leiden University.

ProteoNic and NecstGen establish partnership to improve viral vector manufacturing efficiency for Gene Therapies

ProteoNic and NecstGen establish partnership to improve viral vector manufacturing efficiency for Gene Therapies

ProteoNic and NecstGen establish partnership to improve viral vector manufacturing efficiency for Gene Therapies

Leiden, Netherlands, April 26, 2022 – ProteoNic, a leading provider of premium vector technology and services for efficient production of biologics, and NecstGen, a CDMO and centre of excellence for Cell and Gene Therapy, announce a partnership for the development of improved viral vector manufacturing for gene therapy applications. Both companies, located on the Leiden Bio Science Park, recognise the need to increase viral titres and optimise production processes. Cost-efficiency and manufacturing yield play a critical role in the feasibility of vector-based therapies. Through their combined efforts ProteoNic and NecstGen aim to improve and advance AAV and LV viral vector manufacturing technology and increase production capacity, to the ultimate benefit of patients in need of Gene Therapies.

ProteoNic will apply its established 2G UNic™ technology platform to improve viral vector performance. NecstGen, specialised in the manufacturing and development of various viral vector types, contributes its viral vector platforms, manufacturing processes and experts as part of this partnership. Ultimately the companies strive for the acceleration of novel Gene Therapies by removing existing road blocks related to production efficiency and capacity.

Frank Pieper, CEO of ProteoNic commented “ProteoNic has a strong track record of improving vector performance and production levels in a range of applications. We believe that together with NecstGen we can improve the production efficiency of viral vectors for Gene Therapy, and thereby alleviate current manufacturing constraints”.

Paul Bilars CEO, NecstGen said “This action shows the strength and importance of the local ecosystem, and how working together we can address the challenges of Gene Therapy development and their translation to solutions for patients and society”.

About ProteoNic

ProteoNic is a privately held company with offices in Leiden, the Netherlands and in the Boston area, USA. The company offers technology and services for the generation of cell lines with greatly improved production characteristics, including production levels and stability. The company commercializes its proprietary 2G UNic™ technology through licensing and partnership arrangements. For more information, see www.proteonic.nl.

About NecstGen

NecstGen is a new centre of excellence for Cell and Gene Therapy, located in a purpose-built GMP facility on the largest bio-cluster in the Netherlands, Leiden Bio Science Park. Here, NecstGen provides critical contract development, manufacturing and rental services to academic and small/large industrial therapy developers to deliver a new generation of therapies to patients. For more information visit www.necstgen.com.

 

For more information please contact:

ProteoNic

Mark Posno, PhD

Vice President Business Development

T: +1 617 480 8016

E: posno@proteonic.nl

 

NecstGen

Tristan Pritchard-Meaker, PhD

Head of Business Development

E: tristan@necstgen.com

Outsourcing Cell & Gene Therapy Manufacturing

Outsourcing Cell & Gene Therapy Manufacturing

Outsourcing Cell Therapy Manufacturing

Questions to ask yourself

Cell and Gene therapies include extracting cells or genetic material (DNA) from a patient, altering that material to develop a highly personalized therapy and subsequently injecting it back into the patient. Therapies like these are based on state-of-the-art technology and can require specific, hard-to-find expertise to manufacture. While the entire manufacturing costs are crucial, you also want to ensure a rapid path to market and sufficient flexibility if your plans change.

If you need to produce a Cell or Gene Therapy, there is an ever-growing pool of contract manufacturers offering a range of services and expertise. Due to a scarcity of adequate manufacturing facilities and expert employees, the Cell Therapy sector’s reliance on outsourcing is a constant source of concern.

By outsourcing, you get access to a specialized company’s internal resources, including both its equipment and in-house experts. And, by working with a professional CDMO, you can usually scale up faster.

Here are the questions we recommend asking yourself when deciding if you should outsource your Cell Therapy manufacturing.

Where do you need help?

Outsourcing has become increasingly popular among biopharmaceutical businesses, while others have decided to build in-house production facilities instead. So how did others decide?

It is best to think carefully about what you will outsource. As the need for Cell and Gene development services grows, CDMOs constantly examine and evolve their portfolios and what they can provide to their new Cell Therapy customers. Drug developers are increasingly evaluating the different advantages of outsourcing, including increases in productivity, efficiency gains, quality improvements, and many other aspects that will help them shorten their time-to-market.

Therefore, your analysis should be elaborate and well-thought-out, so you make the right decisions in weighing outsourcing against manufacturing your product in-house. Aspects to consider include:

 

  • Process and analytical development
  • CMC
  • Quality Control
  • Quality Assurance
  • Manufacturing
  • Training
  • Cleanroom rental
  • De-risking capital investment

What is in your pipeline?

A first step toward determining if you want to outsource your Cell Therapy manufacturing is to take a step back and evaluate the number of products in your pipeline. Simply said, that means that smaller biotechs working on a limited number of single Cell Therapy products might be wise to choose a different route than large, established Cell Therapy developers with many candidates in their pipeline. 

Additionally, you will have to consider the kind of therapy you are developing. For example, is your product Allogeneic or Autologous? Fresh or frozen? And what about the administration route? Does your product incorporate a medical device? The characteristics that define your therapy cannot be left out of the equation. They represent an important aspect in deciding if you want to outsource your Cell Therapy production and to which CDMO.

Key here is your product classified as an Advanced Therapy Medicinal Product (ATMP)?

Technology: Two-Sided Sword

Although the lack of certain services or technologies could drive Cell Therapy developers towards an in-house manufacturing facility, there is another option. Some CDMOs offer you the option to invest in the required equipment but can be accommodated at the manufacturing site and subsequently used for your therapy.

To no one’s surprise, Cell Therapy manufacturers should offer modern facilities, including state of the art technology. However, technology is a two-sided sword when choosing to insource or outsource your Cell Therapy production.

Making use of existing technology for Cell Therapy manufacturing

The main benefit of outsourcing is that there is no need for a significant upfront capital investment, and you can access expertise immediately, if no queue exists. Although the waiting time to access contract manufacturing services can be significant, the bandwidth and expertise of a Cell Therapy CMO might mean accelerated delivery times instead of building, commissioning and then manufacturing in your facility. In addition, outsourcing also allows you to manage your cash flow more steadily this way.

Adoption of new Cell Therapy Manufacturing technology

You might want to employ novel technologies to ensure a state-of-the-art manufacturing process. Sometimes it is easier and faster to integrate these yourself in-house than expect a CDMO to prioritize adopting new technology. It is a misconception that because of pressure on CDMOs who currently manage the competing demands, they can’t cater to tailored needs for cell therapy production. 

If swift adoption of your technologies is essential to your plans, you can choose to do so through in-house capabilities, but you can quickly check whether it’s possible at your CDMO too.

The path in between

Although the lack of certain services or technologies could drive Cell Therapy developers towards an in-house manufacturing facility, there is another option. Some CDMOs offer you the option to invest in the required equipment but can be accommodated at the manufacturing site and subsequently used for your therapy. Or rent cleanrooms?

 

What are the costs?

Comparing the costs of building in-house capacity versus sourcing capacity externally for the long term is essential. It would be even better to consider multiple scenarios that take success rates for the processes you are developing into account. And in every budget estimation, you should include unexpected expenditures during the project and throughout its lifetime.

If you’re interested in building an in-house facility, these will be major costs to examine:

  • CAPEX
  • Maintenance
  • Utilities
  • Labour
  • Consumable costs

If you plan on outsourcing your cell manufacturing, these are major costs to examine:

 

  • Operational
  • Pass-through
  • Tech transfer
  • Consumable costs.

    What kind of expertise do you need?

    Core team for your Cell Therapy manufacturing program

    Sometimes, onboarding experts might be strategically advantageous, mainly if you are operating in a highly competitive part of the market. It could allow you to build in-house expertise for your core strengths and expand your team from there on if needed; based on the complexity of your product. Some CDMO, like NecstGen, can also assist you in-house and can train your team. 

    Especially Quality Assurance/Control and GMP manufacturing processionals are essential, and if budget restrictions prevent you from hiring a complete team, consultants might be worthwhile to investigate.

    Multidisciplinary Cell Therapy development

    Suppose you require various competencies and resources, which is likely in a highly innovative environment such as the Cell and Gene Therapy field. Then, outsourcing is an excellent plan. It allows you to take advantage of your partner’s expertise on short notice, which can be an essential success factor in bringing cell therapies to patients.

    Keep in mind that with a CDMO, you’re engaging with an entire organization specialized in manufacturing cell therapies.

    Quality in Cell Therapy Manufacturing

    Most Cell Therapies are initially developed in academic institutions. While this environment excels at producing new leads for future therapies, the lack of experience with GMP infers a rather substantial challenge for a scale-up. Therefore, it is essential to invest early in manufacturing and supply capabilities, including Quality Lifecycle Management and Quality By Design principles.

    You can decrease the notable risks of modifying your manufacturing process in the subsequent development phase by taking these principles into account. The same holds for integrating sound CMC processes early on in your clinical operations. That way, you ensure rapid, uninterrupted product development.

    It is clear that not living up GMP-compliant process puts everything at risk, both the stakeholders and the development of your therapy itself. If you cannot gather an in-house team of seasoned (ATMP) quality experts around you, it might be wise to consider contacting a CDMO.

    Availability & Capacity

    In the longer term, a key consideration is whether a CDMO has the flexibility and capacity to increase (or decrease) manufacturing volumes on demand. So, besides the question, if a CDMO can accommodate your manufacturing at all, limited capacity or flexibility would mean you have to plan and book far in advance.

    You need to ensure that your CDMO can adapt to the maximum required volumes, even though that might seem far away from an early-stage perspective. 

    Of course, it’s not always black and white. For example, as a developer, you can’t always establish a complete set of requirements for an in-house facility if your final scalability needs aren’t precise yet. As a result, many companies go about this decision opportunistic and use outsourcing as an in-between-manufacturing-sites until they fully understand the complete picture.

    How do you ensure Tech Transfer?

    Your technology will transfer from academics to commercialization from smaller labs to larger facilities along with comprehensive process knowledge to reproduce your Cell Therapy at the required quality and scale and in line with regulatory requirements. Therefore, you should ensure a detailed and robust process description, including critical quality attributes (CQAs) and critical process parameters (CPPs).

    If you’re optimistic about keeping manufacturing in-house, there is no need to worry about tech transfer, licensing fees, or concerns about intellectual property rights. Everything is kept in-house.

    Keep in mind that, per definition, most Cell Therapy products are highly specialized and require tailored utilities and experienced, well-trained staff. Not all CDMOs are thoroughly prepped for this particular challenge. As mentioned before, a CDMO can experience difficulties accommodating novel technologies resulting in delayed tech transfer. Our recommendation would be to go over entire the tech transfer process with your CDMO candidates to ensure you’re making the right choice if you want to outsource.

    Are the operators of the CDMO undertaking the development or manufacturing involved in the tech transfer? This can streamline and improve overall success.

    When is the right time to start a conversation?

    When would be an excellent time to speak to a possible candidate for outsourcing your Cell Therapy manufacturing? We recommend when you are transitioning from the fundamental to the pre-clinical stage. CDMOs are also used to make preclinical material, and this will likely be a better outcome.

    Many Cell Therapy biotechs choose to outsource, as it is crucial for your product development.  Although it is best not to rush into commitments, the earlier you start a conversation the better. As long as you thoroughly inventory your needs and analyze potential partners’ capabilities and in-house quality and expertise.

    So, to sum up, all the items you should investigate if outsourcing is a good fit for you, you should look into your needs regarding:

     

    • Type of Cell Therapy
    • Budget estimations
    • Technology requirements
    • Regulatory and CMC expertise to upscale 
    • Quality / GMP expertise to mitigate risk early on
    • Availability of established process development 
    • Flexibility and scalability of manufacturing
    • Understanding of technology transfer

      Related Questions

      Which Cell Therapies are approved?

      In these figures, we gathered and visualized overviews of approved ATMPs over the past years for you.

      What does the Cell Therapy Development process look like?

      From idea to treatment, you’ll face changing requirement and development challenges. View the figure to see how knowledge of the process inversely relates to freedom to make changes to your process.  

      Our experts are only a message away to help you understand the impact of any of these aspects and make informed decisions on outsourcing.

      We’d be happy to discuss and help you bring cell therapies to patients.

      NecstGen participates in € 300 million stem cell consortium

      NecstGen participates in € 300 million stem cell consortium

      NecstGen participates in € 300 million stem cell consortium

      Today, the Novo Nordisk Foundation announced the € 300 million funding of an international consortium including Leiden University Medical Center, the Danstem Institute at the University of Copenhagen and the Murdoch Childrens Research Institute in Melbourne to bring stem cell-based therapies from the laboratory to the patient.

      NecstGen collaborates in this consortium as development and manufacturing partner to help advance cell and gene therapies through clinical development.

      During a 10-year period, the consortium will focus on tissue reconstruction, clinical application of stem cells, and genetic modification techniques.

      Cell Therapy Manufacturing & Development

      NecstGen offers a wide range of services and expert professionals for Cell Therapy developers.

      Viral Vector Manufacturing & Development

      NecstGen provides a high-caliber process for Viral Vector manufacturing for your Gene Therapy.

      Cleanroom Rental

      NecstGen offers flexible GMP Cleanroom Rental at a state-of-the-art facility.