Viralgen Vector Core SL, established only a few years ago, seems to be on track with its mission to help its clients obtain therapeutics of the highest quality, at the right time and the right scale, supporting transformative medicines for genetic disorders including rare and ultra-rare diseases.
The company was established in 2017, as a joint venture of Asklepios BioPharmaceutical (AskBio), a leading gene therapy biopharmaceutical company with now over 800 employees in five countries, and Columbus Venture Partners, a Spanish venture capital firm focused on biotech companies.
In 2018, Viralgen began operations in San Sebastian in the Basque Country, Spain, with a clear purpose—to provide access to medicines for people with genetic diseases. Today, Viralgen operates as an independent subsidiary of AskBio and a member of the Bayer worldwide group of companies, following the acquisition of AskBio by Bayer AG in 2020.
Unique in the market
Viralgen specializes in the production of recombinant adeno-associated virus (rAAV) vectors for gene therapies using Pro10TM, its proprietary suspension, triple transfection platform. Pro10TM, is a HEK-293-derived suspension cell line, a scalable upstream platform and robust purification process, coupled with full support for fill and finish, QC testing, and regulatory support from preclinical through commercial stages.
Viralgen’s CEO Jimmy Vanhove says: “What is important for us is that we have fully integrated operations to develop and manufacture vectors all the way from clinical to commercial scale, including in-house quality control testing as well as formulation and filling. We believe that is a great competitive advantage.”
He explains that he believes a second differentiator is Viralgen’s technological platform, a proprietary cell line, that significantly shortens the time to market. “We can provide our clients with cGMP clinical material in under nine months, which is exceptional when compared to the standard time of over 12 months.”
What also seems to set the company apart is its level of expertise, “Because we’re so focused on AAVs, and work with AskBio, we have a high level of scientific understanding, development experience and regulatory expertise that we believe is unrivalled by most other Contract Development Manufacturing Organisations (CDMOs). We think that combination of process development and regulatory expertise is unique in the market.”
Still, there may be one more aspect that makes Viralgen exceptional—its talent base. “Of the 400 people that we now employ, over 75% have advanced degrees, with 25% holding doctorate degrees and over 50% with master’s degrees. That capability and that level of scientific power are special. What’s more, the level of staff turnover has been below 3% since our inception. So not only do we attract but we also retain that knowledge. There’s a continuity of knowledge that we keep in the company, and also a continuity where we interact with clients.”
The human touch
Its attractiveness for potential employees was one of the reasons why San Sebastian was chosen as Viralgen’s location—a picturesque set-up, accessible to people from Spain, France and other countries.
“We have a very diverse team of people and to close the gap of missing competencies, we defined a special program with the local Basque government, to provide higher-level vocational training students with the opportunity to complete dual training with Viralgen during their second year. After completion, the students can either choose to stay with us or to apply their skills in the market.”
This initiative has, over the past year, created a biotech ecosystem, a pool of competency and capability in San Sebastian, so that talent attraction is no longer a hurdle for the company.
Mr Vanhove points out that Viralgen is very purpose-driven, and everyone in the company is exceptionally aware of the impact their work has on individuals’ lives. “The majority of people suffering from rare or ultra-rare genetic diseases have no hope, as there is no cure. So that purposefulness is the foundation driving us to succeed every day. The understanding that we are working towards something that really makes a difference is closely related to our corporate social responsibility activities, a key component of Viralgen’s ‘DNA’, which is present throughout the entire organisation.”
Following this principle, Viralgen closely works and supports the Columbus Children’s Foundation and Fundación Columbus—two foundations devoted to the development of cures for ultra-rare disorders, which were started by Viralgen’s founders Sheila Mikhail, Dr Jude Samulski, and Javier Garcia.
“Through this activity, we get to know some of the patients by name, and they even come and visit the site. That’s something that I, as a CEO, am really proud of. These initiatives, as well as the interactions with patients, help to further increase our employees’ awareness of our purpose, as well as of the role they play in contributing to major life enhancements. The social aspect is something that I want to continue to push for.”
Accelerating the pace
Mr Vanhove reflects that gene therapy is a growing field, a new frontier of life sciences and medicine, giving hope to patients suffering from diseases for which there is no current cure. In this context, the company is set to continue to help broaden access to these life-saving therapeutics and contribute to health advancement and human welfare worldwide, and it can be rightfully proud of the progress it has made so far.
Since starting operations in 2018, Viralgen has made rAAV for clients all over the world. As of mid-2022, the company has supplied more than 600 research batches to customers and has supported multiple clinical trials in the US, Canada, and Europe.
“Through our manufacturing, we have also been involved in and enabled over 26 clinical studies worldwide and have manufactured over 60 clinical cGMP batches and more than 600 smaller preps and development batches, which we believe is exceptional.”
“Not only do we believe that the rapid development of a business that started with just seven people five years ago and has grown to over 430 today has been handled successfully, but also expect further growth as Viralgen expands its capacity and capabilities.”
Major stepping stone
In December 2022, Viralgen achieved a major milestone when it received the Certified Good Manufacturing Practices (cGMP) certification for the manufacture of human medicinal products, investigational medicinal products and sterile or biologically active substances. This certification was granted following a successful inspection by the Spanish Agency for Medicines and Medical Devices (AEMPS), part of the European Medicines Agency (EMA) network.
The certification expanded Viralgen’s capacity threefold and is believed to position the company as a world-leading CDMO. Viralgen is now licensed for the commercial manufacturing of recombinant adeno-associated virus (rAAV) gene therapies with a scale up to 2,000 l.
The certification also concluded the first phase, or the first module, of the expansion of the new facility, which now has three independent state-of-the-art commercial manufacturing suites with 500- and 2,000-liter single-use bioreactors. Viralgen will also establish manufacturing, science and technology (MSAT) labs at the same facility by the end of the second quarter of 2023.
“Being a fully integrated CDMO, we offer a continuum of products and services, including process, analytical development, stability studies and fill-and-finish for all types of rAAV serotypes,” says Jimmy Vanhove. “We expect this to significantly shorten the time to market, help with the predictable cost of goods and reduce the waiting time experienced by patients who have run out of options and are hoping for breakthrough treatments.”
“With the new commercial manufacturing facility and the cGMP certificate, we can now support not only clinical material but also commercial material. This really is a major stepping stone that enables Viralgen to expand its ability to partner with customers in the rAAV space who are initiating Phase 3 studies and seeking approvals to commercialise their products.”
Market developments
This is a particularly interesting time in the history of Viralgen, as it is set to expand its capabilities and capacity to ultimately produce viral vectors in up to nine independent cGMP suits for commercial products.
Mr Vanhove points out that Viralgen embraces current market developments, of which digitization clearly stands out. “In our industry, digitization is critical. Thanks to our digitization efforts, we are putting systems in place that enable data usage to continue to optimize insights into the manufacturing process for our clients, and ultimately and importantly, for regulators. And that focus is unique, as well as critical.”
“The second important trend within the gene therapy market is related to the use of synthetic DNA. This has significant manufacturing and purity advantages along with faster turnaround times.
With our sister company TAAV, which is located down the road, we are particularly well positioned to deliver upon this trend and support clients by utilizing their synthetic (dbDNA) DNA as the starting material to manufacture rAAV vectors to get our clients into the clinic faster.”
“Funding in this market is critical. Given the current inflationary environment, the biotech sector has seen a significant drop in its ability to attract investments. This is currently a significant challenge for the industry.”
“The next big challenge is regulatory. Today, over 2,500 cell and gene therapy clinical trials are underway. Agencies like FDA and EMA are overwhelmed with reviews and applications, leading to delays, and potentially extending the time needed for novel therapies to reach patients. At Viralgen we have significantly ramped up our regulatory team to support clients with their applications and leverage our experience.”
However, Mr Vanhove affirms that Viralgen will never lose sight of its purpose and the commitment of its people to drive the change in enabling novel therapies.
World reference
To this end, Viralgen is set to continue to invest in further expansion to complete its modules two and three, which will eventually increase the company’s production capacity six-fold, and is expected to enable the democratization of gene therapy, both in volume and speed of production, while decreasing manufacturing costs.
“We can ramp up operations within a 12- to 18-month timeframe, whenever we need more capacity, and build out a new module, or whenever we need to add new technology to support the gene therapy CMDO business. The objective is to accommodate any type of manufacturing requirement coming from the global gene therapy market, and to be operationalized and geared up within record time.”
Mr Vanhove himself assumed his role at this transformational time for the company, following in the footsteps of its CEO and co-founder Javier Garcia. Starting as CEO in January 2023, he brings a wide range of biotech strategy, operational management, and digital transformation experience to his new position. Prior to joining Viralgen in 2021, he served as Chief of Staff at Bayer Global Technical Operations and also held various leadership roles in manufacturing and strategic consulting at multinational companies such as GSK Vaccines and Roland Berger.
He holds an MSc in Bioscience Engineering from KU Leuven and an MSc in General Management from Vlerick Business School and also holds an executive qualification in Digital Transformation from IMD, Lausanne, and in Executive Management Development at IESE Business School, Barcelona.
He has a clear view of how he wants to steer the company into the future: “We have arrived at the next stage with the commercial facility. Ultimately, we want to consolidate our position as a global leader in the CDMO rAAV field, recognized for our speed, quality and expertise.”
“We will continue to support commercial manufacturing, continue to support the biotech companies that have novel treatment therapies. We are in a privileged position to benefit from the stability of Bayer, while operating as an independent subsidiary of one of the most innovative gene therapy companies in the field, AskBio. This allows us to maintain our uniqueness and our innovation capability and our own entrepreneurial culture. That is something that I will continue to push forward.”
With its clear purpose and a strong aspiration to provide access to curative medicines to people with genetic diseases, Viralgen is set to turn into a world reference in a sector that is changing the history of medicine.
