Partnering with Scientific Excellence to Derisk and Accelerate Drug Development

The company has significantly expanded its service scope and geographic reach, enhancing scalability and adapting to dynamic market needs. Today, Coriolis stands out not only for its deep scientific expertise but also for its commitment to acting as a strategic partner through all stages of client drug product development — emphasizing a tailored approach that accelerates client projects from concept to commercialization. In this Q&A with Pharma’s Almanac Editor in Chief David Alvaro, Ph.D., Coriolis’ Chief Executive Officer Silvia Steyrer-Gruber discusses the company’s history, scientific strengths, and unique position in the contract research and development sector.

David Alvaro (DA): I am excited to learn about Coriolis Pharma. Let’s start at the beginning: can you share the story of the genesis of Coriolis and the foundational vision?

Silvia Steyrer Gruber (SSG): Coriolis was established in 2008 in Martinsried, near Munich, a prime biotech hub in southern Germany. This location is pivotal, as it’s surrounded by a vibrant culture of innovation. The company originated as a spinoff from Ludwig Maximilian University, Munich’s Department of Pharmaceutical Technology. The majority of the original founder team remains actively involved today as shareholders or scientific advisors or in operational roles. This continuity forms a solid foundation for Coriolis, both now and into the future.

From its inception, Coriolis has been self-sustaining, growing through its dedication to merging scientific rigor with commercial acumen. This synergy helps our clients accelerate the market readiness of their products —biopharmaceuticals, including gene and cell therapy products and vaccines — enhancing quality and reducing risks.

Initially, our focus was on formulation development and analytics for antibodies and complex biopharmaceuticals, such as mRNA–LNPs, which were not mainstream 10 years ago. Formulation remains a core strength, but our expertise has broadened significantly. Today, we offer a comprehensive range of services, including advanced drug product development, manufacturing services, and both GMP and non-GMP analytical services, supporting our clients comprehensively. In addition, we have emerged to cover innovative gene and cell therapy products, with focus on viral vectors that require biosafety level 2.

DA: Were there any critical milestones or inflection points along the way that you can highlight?

SSG: As a university spinoff, we began in university labs but eventually moved to an incubator office here in Martinsried (Munich) in 2009, a common starting point for many startups, until moving into our own premises in 2017.

One of the most crucial milestones was achieving GMP certification in 2012. This certification has been essential, as it allows us to work under both R&D and GMP standards, which is essential to support the needs of our clients.

More recently, in late 2021 to early 2022, we inaugurated a new laboratory for biosafety level 2, focusing on cell and gene therapies and ATMPs (advanced therapy medicinal products). This step underscores our commitment to spearheading innovation in the pharmaceuticals on the market today were developed years ago, and the R&D of the future is happening now. Our approach covers the entire spectrum from early development to commercial stages, ensuring we support our clients throughout the life cycle of their products.

DA: Has the core vision changed significantly since the company’s genesis, or has it simply strengthened as you’ve added new services?

SSG: Our core vision as a scientific powerhouse to support the development of biopharmaceuticals has not only remained intact but has also strengthened. The foundation of our work has always been deep science, which drives our ability to perform at high levels. Our services have significantly broadened from our original focus on formulation development, yet they still rest on this scientific foundation. This allows us to engage effectively with our clients’ scientists, offering them not just research but tailored solutions that meet their specific needs in a phase-appropriate way during drug product development.

DA: In terms of the awareness and perception of Coriolis: to what extent do people in the industry understand what Coriolis brings to the table?

SSG: The awareness of Coriolis varies geographically. In Germany in particular and Europe overall, our presence and capabilities are well recognized within the biopharmaceutical and CDMO sectors. In the United States, which accounts for about 30% of our business, we are known primarily for our scientific expertise in formulation development, but our comprehensive commercial services, including GMP services, are less known. Once we engage with new clients, we find that their understanding of our full scope of services broadens significantly. This interaction often reshapes their perception, recognizing us not just as a scientific consultancy but also as a full-service partner capable of supporting them commercially.

We engage with clients right from the early phases of drug development. As soon as they have their first clone material or drug substance in the late discovery stage, they can come to us for our recently introduced new services –– developability assessment and pre-formulation screening –– as well as further development support, including formulation development and various analytical services.

Our support extends through the entire development process, from early phases right through to commercial stages, including clinical phases I, II, and III and beyond. A critical aspect of our service is ensuring that products are market-ready, which goes all the way to container closure studies to select the appropriate end container using the right methods and tests.

We also support clients as they move toward commercial-scale manufacturing. This includes performing tech transfers to ensure seamless integration and coordination with the CMOs (contract manufacturing organizations) they use.

DA: Do customers predominantly engage Coriolis for an integrated suite of services, or do you still see clients seeking specific, à la carte services?

SSG: We cater to both types of needs. Our client base is diverse, ranging from small and virtual biotech firms to large pharmaceutical companies, including many from the top 20 globally. Our services are tailored accordingly — we provide comprehensive support from early development to commercial stages, as well as specialized services for specific needs.

For instance, long-standing clients may engage us throughout their development process, while others approach us with distinct issues, such as particle analysis, where we offer targeted expertise. Whether it’s a full-spectrum service for multiple molecules or precise troubleshooting for a single molecule, our approach is flexible. We offer both GMP and non-GMP analytical services, adapting to the specific requirements and scale of our clients, which is often a critical factor for them.

DA: How do you see Coriolis Pharma best differentiated from peers or competitors within the CRDO (contract research and development organization) sector?

SSG: We occupy a unique position in the CRDO sector. On the one hand, there are large organizations primarily focused on commercial-scale manufacturing, including some formulation services. On the other hand, there are those more upstream, working on drug substance and developability but typically handing programs off early in the development chain. There are also niche firms that specialize exclusively in formulation development.

Coriolis stands in the middle, integrating these different aspects. We provide developability assessments and pre-formulation screening, which allows us to engage earlier than many firms that offer only formulation services. Additionally, we extend our involvement beyond what typical drug substance–focused companies offer by serving as an effective bridge to later stages. This capability positions us uniquely as a CRDO that delivers a qualitative, comprehensive approach, facilitating a smooth transition to CMOs at later stages.

DA: Speaking of developability assessments, do you see that as a service whose importance is increasingly recognized?

SSG: Absolutely –– these early assessment services are becoming crucial. By putting ourselves in our clients’ shoes, we recognize that our role isn’t just to pursue science for its own sake; it’s about helping clients solve their challenges, advancing their projects, and reducing risks while speeding up their processes. The new services we’ve introduced are specifically designed to accelerate client projects toward phase I more efficiently, as a bridge from discovery towards clinical development.

The objective is to enable quicker decision-making on which projects to advance, focusing on acceleration and risk mitigation, and our comprehensive approach is key. Even if a project encounters complexities, such as a molecule that is difficult to formulate or requires extensive work, our clients don’t need to seek a new partner for troubleshooting. We provide a tailored approach from the start, allowing them to continue collaborating with us through the development continuum, ensuring a seamless transition and sustained support.

DA: In developing these platforms, were you responding to direct customer requests, or was this more of a proactive expansion on the part of the company?

SSG: It’s truly a combination of both. Our approach to service development has always been highly collaborative with our clients. Often, clients will express a need, prompting us to set up collaborations, sometimes involving pharmaceutical companies or instrument providers, to advance our research and develop new services that can benefit a wider client base.

The development of these particular services, however, was driven internally. We took the feedback and needs expressed by our clients and returned to the drawing board, leveraging our extensive experience with various products and the cumulative knowledge within our team. We spent considerable time developing these services internally, ensuring we fully understood and perfected them before launch. This meticulous approach ensures that when we introduce a new service, it is not just a response to demand but is well-founded and thoroughly vetted, ready to effectively meet client needs.

DA: Are those platforms applicable across the modalities you work with, or are they more specifically tailored to certain types of molecules?

SSG: Our platforms are currently focused primarily on the antibody field, where both our company and the broader scientific community have a substantial depth of understanding. However, we are actively working to extend these platforms to include newer modalities. The applicability to other modalities will depend on the specific needs and developmental stages of our clients’ molecules or their conceptual ideas, as well as the analytical requirements of the modalities. For novel modalities, we conduct pre-formulation and developability work, individually set up for the modality, because there is not yet a lot of prior knowledge on novel modalities available.

DA: Given the diversity of your client base from virtual biotechs to big pharma, is there an ideal type of organizational fit, or specific types of companies that stand to benefit most from a partnership with Coriolis due to their needs?

SSG: Our client history showcases a broad spectrum ranging from virtual biotechs that outsource nearly everything to large biopharmaceutical companies where we’re seen as field experts. This mix is ideal for us, as it allows for mutual learning and growth. Smaller, more agile biotechs, particularly in early phases, benefit greatly from our extensive experience with larger organizations, enhancing their commercial prospects.

Furthermore, we engage in strategic partnerships with other contract organizations, since we provide services up to the point where a client requires GMP manufacturing. Collaborating with these partners, known for their quality just as Coriolis is, extends our ability to support clients seamlessly through their scale-up processes. This collaborative approach not only leverages our strengths but also enhances our combined offering to potential clients.

Additionally, we’ve nurtured long-term relationships with companies that started small and grew or were acquired by larger entities. This continuity is beneficial; we provide consistent support as companies scale, leveraging our expertise to guide them through complex regulatory landscapes and partnership dynamics. Essentially, our approach is to cultivate a symbiotic relationship where learnings are shared across the spectrum — from smaller ventures to multinational corporations — facilitating a cycle of continuous improvement and adaptation.

DA: Could you expand a bit more on your approach to partnerships with customers and how you manage communication and collaboration?

SSG: At Coriolis, our relationship with clients is fundamentally based on partnership rather than a simple provision of services. From the onset of a project, our primary touchpoints involve direct communication between our scientific project groups and the client’s scientists. This scientist-to-scientist dialogue is crucial, as it fosters a collaborative environment that we believe adds significant value to the project.

While project management plays a role in coordinating efforts, our emphasis is on establishing a partnership that evolves with the project. For larger or more complex projects, such as those in formulation, we begin with a strategy informed by our collective experience and knowledge. We then tailor this approach to meet the specific needs and requirements of the client’s molecule. This process is dynamic, adjusting over time to ensure a deep, continual connection with our clients, which is vital for the success of the project.

DA: Earlier, you noted that Coriolis is perceived somewhat differently within Europe compared with other parts of the world. Is that reflected in the clients you work with?

SSG: Our client base is indeed international, with a significant focus on Europe and the United States, where about 30% of our business is concentrated. While we serve clients globally, our strategic emphasis is on these regions owing to their strong growth potential.

In addition to our presence in Europe and North America, we have a partnership with U-Medico, a Japanese company with a similar focus, which enables us to reach Asian markets. This collaboration is part of our broader strategy to enhance our service delivery across different geographies.

DA: As you look toward the near future, do you foresee any significant changes on the horizon in the types of support biopharma companies will seek from CROs, CRDOs, and CDMOs?

SSG: Absolutely; the biopharmaceutical industry is evolving rapidly, and our approach must adapt accordingly. Our newly launched platforms are crucial, because they enable us to expedite client projects more efficiently. This trend toward speed and efficiency isn’t new, but the demand for seamless integration in these areas is growing stronger.

Furthermore, as we progress, the need for profound scientific expertise remains paramount. New modalities are emerging that differ significantly from traditional antibodies, requiring a deep understanding and an innovative approach to development.

Another significant trend shaping our industry is the integration of digital technologies, such as artificial intelligence, including machine learning. These tools are becoming essential not just for Coriolis but across the biopharmaceutical sector, as they enable more sophisticated data analysis and decision-making processes. This digital transformation is something we are actively incorporating into our services to stay ahead and meet the future needs of our clients effectively.

DA: Is there anything else you can share about the people that enable Coriolis to operate so effectively?

SSG: Coriolis is fundamentally a people-driven business. Unlike operations focused on mass production, our core is rooted in the depth of our scientific engagement. We pride ourselves on having a highly international and educated workforce, with 36 nationalities represented in our team. In addition to this, our diversity spans a wide breadth of skill sets and backgrounds. Our team is mainly composed of pharmacists, chemists, biologist, engineers, and computer scientists,. This diversity brings a broad range of perspectives to our scientific endeavors.

Our projects typically involve teams composed of Ph.D.- and master’s-level experts in various scientific fields, ensuring that we bring top-tier scientific expertise to every client project. This intellectual capital is critical to our success and central to the services we offer.

Additionally, Coriolis was founded and led by entrepreneurs for its first 14 years, imbuing our company with a resilient entrepreneurial spirit and a proactive “can-do” attitude. This spirit is something we actively preserve as it’s integral to our identity and approach. Even as we expand globally and enter new phases of growth, maintaining the core values that make Coriolis unique remains a top priority.

DA: Aside from the entrepreneurial spirit of the founders, is that original sensibility from the company’s roots in academic research still in the company’s DNA?

SSG: Absolutely, the academic research ethos is deeply embedded in our company’s DNA and continues to distinguish us in the industry. Our ties to academia remain robust; for instance, one of our founders, Andrea Hawe, serves as our Chief Scientific Officer and maintains strong connections with universities, which facilitates a continuous exchange of knowledge and innovation.

We also have a team of 12 scientific advisors from Europe, the United States, Japan, Brazil, and other regions, most of them renowned university professors, who contribute diverse insights and expertise to our projects. This expansive scientific network ensures that our approach remains deeply rooted in cutting-edge research and scientific rigor.

As we’ve grown, this foundation has expanded beyond the founders to include our entire team, integrating a broad spectrum of scientific expertise into every aspect of our operations to ensure that our strategies and processes are continually informed by the latest academic research.

Our more than 150 peer-reviewed publications speak for themselves.

DA: As Coriolis continues to grow, will expansion be operations within Germany or in other regions?

SSG: Both. We’re well-established in Martinsried (Munich), Germany, where we already have a strong foundation with two laboratory buildings equipped with over 120 instruments. Here, the potential for expansion is significant.

Martinsried is truly a stronghold for biotechnology, teeming with startups and established biotech firms. This dynamic setting not only facilitates collaborations but also attracts a diverse international workforce. We actively engage with the academic community here, contributing to and benefiting from the wealth of knowledge and innovation. Our involvement ranges from local Ph.D. and master’s programs to extensive collaborations with international scientists and professionals. This global reach and strong local integration enable us to maintain high standards of scientific excellence and innovation in all our projects.

Internationally, we’ve already started collaborating in Japan and have started a strategic expansion into the U.S. market. We’re approaching the U.S. expansion stepwise, ensuring that we establish a sustainable and effective presence. Our first step has been to set up our own company, Coriolis Pharma U.S. Inc., recruiting a team of highly qualified commercial team members, including client project management, and establishing a “concierge model” to serve our U.S. customers even better. With this model, we ensure that our clients have easy and fast access to our services in our state-of-the-art labs in Martinsried, Germany, without having to deal with the typical barriers of collaborating with a European company, such as different time zones or logistics/shipments between the United States and Europe.

DA: On top of Coriolis’ long-term vision, can you share anything about new priorities or initiatives that have emerged under your leadership since you joined in 2022?

SSG: My background in Big Pharma and biotech environments shaped the approach I have taken since joining Coriolis. The company’s original strategy was strong and robust, and my focus has been on refining and prioritizing our objectives to ensure that we progress diligently and effectively.

One significant area where we made an impact since 2022 is the focus on enhancing the scalability of our services. This comes with a structured approach where, as a team, we truly rethink the way we offer our services to existing and potential clients. Additionally, we’ve broadened our operational scope and geographic reach, aspects that have evolved through collaborative discussions within our team and by adding key new senior management members, such as our CCO, Johannes Clemens.

This expansion into new service areas and regions is not just a growth strategy but also a way to integrate diverse scientific and operational insights that align with our long-term vision. This approach ensures that while we expand, we remain adaptable and responsive to the dynamic needs of the biopharma industry.

DA: To tie everything together, what is the key takeaway you would like readers to remember about Coriolis Pharma?

SSG: At Coriolis Pharma, we position ourselves not just as a service provider but as a strategic partner for biologics drug product development. We engage with clients at every stage of their development journey, enabling them from early phases through to commercialization. Our approach is tailored to meet where our clients are in their process, providing deep, specialized knowledge when needed and flexibility to accelerate their timelines. Whether it’s in-depth scientific expertise or agile response to fast-paced demands, we’re equipped to support our clients’ growth and success in the biopharmaceutical field effectively.