Headquartered in Ravensburg, Germany, Vetter is a family-owned, global contract development and manufacturing organization (CDMO) with production facilities in Germany, Austria and the U.S. Currently employing more than 5,700 individuals worldwide, the company has long-term experience in supporting biotechnology and pharmaceutical customers both large and small.

Vetter services range from early-stage development support including clinical manufacturing, to commercial supply and numerous packaging solutions for vials, syringes and cartridges. As a solutions provider to the pharmaceutical industry, Vetter supports the needs of its customers by developing devices that contribute to increased patient safety, convenience and enhanced compliance. Great importance is also given to social responsibility including environmental protection and sustainability.

The company does not have a traditional CEO at its helm. Instead, the responsibility of day-to-day management is shared between two Managing Directors—Peter Soelkner and Thomas Otto. Both were kind enough to spend some time providing details about Vetter’s business operation as well as share their insights into industry trends impacting the CDMO sector in general.

Contract Pharma: What led you to your leadership roles as Managing Directors of Vetter?

Peter Soelkner: My education includes an MBA in chemical engineering in 1992 from the University of Dortmund, Germany, and an MBA in management in 2001 from Columbia University in New York. Before joining Vetter, I held positions in both Germany and the U.S. at Sartorius Stedim Biotech. In my first position at Vetter from 2003-2007, I was responsible for sales and key account management, after which I joined Sartorius in the U.S. to serve as vice president of global key account management. I returned to Vetter in 2008 as a Managing Director and am currently responsible for the areas of global key account management, customer project management, supply chain management, human resources and corporate development/compliance/IT.

Thomas Otto: I graduated from the Technical College in Stuttgart, Germany, with an engineering degree in packaging technology. In 1990, I joined Vetter as a project engineer. From 1995 to 1999, I managed the department of packaging materials development and in 2002, took on the position of Managing Director. Along with Peter and our senior management team, we make the joint decisions that affect the overall business direction of our company and lead Vetter in the day-to-day business. Specifically, in my current role I am responsible for the areas of development service, pharmaceutical production, quality, technical service and internal project management, as well as finance/controlling.

CP: How has Vetter’s business evolved in recent years? What do you find to be most unique about the company?

Soelkner: We have seen significant changes occurring in the biopharma industry over the past several years that of course also have affected the evolution of Vetter. For example, the market share of rare disease treatments is predicted to double by 2026 to roughly $268 billion. Since these treatments are often based on highly sensitive molecules that are delivered parenterally, they have fueled the surging demand for technically sophisticated development and manufacturing support. We are also seeing a continuing shift in customer structure with a greater number of innovative small and mid-size biotech companies looking for experienced partners to bring their molecules to the clinic and to the market.

Otto: We are also seeing a rising focus on sustainability. Unfortunately, biopharmaceutical manufacturing requires a great deal of energy-intensive production operations which leads to a significant carbon footprint. In response, we have been taking innovative steps toward change, for example, from introducing renewable energy to new wastewater strategies, to sustainable packaging options, thus making a valuable contribution toward reducing emissions. We see our responsibility toward both patients and the society. That is why we have adopted a holistic approach, and over the years, invested in various energy-efficient and environmentally friendly technologies. By working together to protect our environment, biopharma companies and their partners will help create an increasingly green value chain.

CP: What are some company highlights from the past 12 months?

Otto: We officially opened our new corporate headquarters at our Schuetzenstrasse site in Southern Germany, albeit, a year later than planned due to the pandemic. We also received manufacturing authorization for our new Development Service site in Rankweil, Austria, which expands our manufacturing capacities for supporting the early-stage clinical development needs of our global customer base.

Significant progress was also made with our collaboration with Rentschler Biopharma. Here, our intent is to create long-term value through the alignment of manufacturing approaches. By joining forces, we strive to enable customers to bring their complex drug products to patients faster and more easily.

Other highlights included the opening of our new China office which since then helps to showcase Vetter’s expertise in the Asia-Pacific region. It also helps to build and strengthen our business network in China while better serving the needs of our growing customer base worldwide. Most recently, we were particularly proud to issue our first Sustainability Report, a further milestone in our sustainability pathway.

CP: How have you had to change to adapt to the COVID-19 pandemic?

Otto: We have experienced postponements of some clinical trials which, in turn, have affected the timelines for the manufacturing of necessary clinical trial material. Especially in the beginning of the pandemic, we have also seen a rising demand for some specific medications necessary for Covid-19 patients with intensive care needs in hospitals. Since the start of the pandemic, we have remained ever-vigilant, closely monitoring the situation on a global basis and enforcing safety measures. By doing so we have been able to keep all of our facilities fully operational.

Among these initiatives was the creation of a cross-functional task force that deals with first and foremost the safety of our employees, external delivery risks, continuous stock and order analysis for bottlenecked materials. This is especially important as the supply market is very dynamic and the external supply chain is tight in some categories. As long as the pandemic continues, we will, along with our partners, continuously monitor the situation to do everything we can to realize the delivery of life-critical medications to patients around the world. The safety of our employees worldwide and the supply of our customer’s drug products was and will always be our highest priority.  

CP: How do you see the injectable drug delivery space evolving over the next few years?

Soelkner: As it pertains to the biopharma sector and the injectable market specifically, we see highly sensitive parenterally delivered molecules fueling a surging demand for technically sophisticated development and manufacturing support. Consequently, we have experienced a growing strategic role for companies like ours, specializing in aseptic fill-finish for injectables.

In China, for example, there is a move away from me-too products and towards innovation. This transition is driving a surge in demand for partners with the expertise and networks that Chinese companies need to scale-up and expand internationally. For us, this makes China very interesting for our long-term growth strategy.

At the same time, the wave of novel agents is ushering in a new era for our industry. Cell, gene and other DNA-based therapies are making the transition from scientific innovation to groundbreaking medications. In fact, the FDA predicts that 10 new cell and gene products will be approved every year until 2025. Many of these “third-wave” biologics are based on sensitive, technically challenging molecules that require highly specialized development and manufacturing support to achieve commercial viability. These innovations are important to keep an eye on as they have the ability to change the technological and operational contribution of supply chain partners involved.

CP: What are some key trends and challenges on the clinical development side of your business?

Otto: Our industry is at an extremely dynamic point in time. Over the last decade and well into the future we see high global demand combined with numerous unmet needs. There is a strong demand for specialized, targeted and precision therapies that represent a wide variety of complex medications. To continue to be successful we must deal with the challenge of managing this complexity.

While we are still producing injectable drugs using syringes, cartridges and vials, there is a high degree of pressure when it comes to innovative delivery systems. For example, managing the actual product and developing a novel and even-more efficient system of administration. This goes hand-in-hand with aspects such as providing convenient solutions to maintain a high degree of patient adherence, for example, when patients have to administer their own medication on a regular basis. In the short-term, we envision a strong and dynamic market with new biologics projected to account for more than 50% of all new drug registrations among the international agencies. We also continue to see ever more complex molecules which means the development of a suitable drug-delivery system is equally complex.

Meanwhile, on the customer side, we have two scenarios. On the one hand, we have small and mid-size biotechs that have a significant need for consulting combined with the uncertainties that often accompany funding from venture capitalists. At times, this can affect project timelines. On the other hand, we experience large pharma and biotech requiring individualized services. The key to meeting all of their needs is to be prepared for any scenario. This is why we consult with the philosophy, “Think with the end in mind right from the start.” Doing so alongside our customers helps us to make the journey of development and subsequent filling and packaging of high-quality drugs as efficient and fast as possible. And that is to everyone’s benefit.

CP: How about on the manufacturing front? What are the trends here?

Soelkner: We face multi-dimensional trends when it comes to manufacturing. For example, throughout the ongoing pandemic, we have been working tirelessly to maintain our supply chain to enable patients to continue to receive the mostly life-saving medications they rely on. This is a challenging task that demands the dedication and efforts of all our employees worldwide.

Another challenge is the ever-growing importance of sustainability in our business operations. This issue is of particular importance to the biopharma industry because the production of critical medications is, nevertheless, resource-intensive. The required high standards and strict, ever-increasing, and absolute binding regulations by international healthcare authorities make it difficult to entirely avoid residual emissions. The “Green Deal,” initiated by the European Union sets a climate goal to be the “world’s first climate-neutral continent” by 2050, by reducing greenhouse gas emissions by more than half by 2030. As such, we must achieve a delicate balance—strictly achieve the high regulatory requirements while striving to enable environmentally friendly usage of resources that contribute to meeting the climate goal.

CP: How can injectable drug development and manufacturing projects benefit from companies like Vetter?

Soelkner: With more than 40 years of experience in the fill and finish business as an independent specialist with expertise in complex, sensitive compounds we well understand that our customers demand the following assets from their strategic partners: quality and technology leadership, expertise, security of supply, flexibility and innovation. It is these factors that are critical to the successful manufacturing of their valuable compounds. As a trusted partner for biopharmaceutical customers of every size, we are scalable and offer high-performance processes and a robust supply chain. Our high-quality level is proven by regular customer audits and international authority inspections. For example, in 2021, we have performed more than 70 customer audits and regulatory inspections at our global facilities successfully.
 
CP: What are your customers’ key concerns when partnering on projects?

Soelkner: As a strategic partner, we provide skilled support and state-of-the-art fill-finish services at every step of the injectable product life-cycle—from initial clinical manufacturing and regulatory approval to successful launch, commercial production and beyond. As mentioned before, for customers that come to us for processing their complex molecules, their most important concerns are quality, feasibility and reliability. Since we do not manufacture our own drug products, our customers know that our only role and primary focus is to support the successful development and later-on the global supply of their life-changing injectable medications.

CP: Broadly speaking, what are some of the key current pharma/biopharma trends impacting CDMOs and services?

Otto: One of the most significant trends is sustainability. Successful companies with high reputations are expected to be not only financially stable but also socially responsible. That means using natural resources whenever possible and meeting high ethical standards. As such, a key trend is the sustainability of the entire supply chain. Companies should act in a sustainable manner by doing all that they can to support our climate. Doing so can mean a competitive advantage in both the industry and the community since pharma and biotech companies are more often looking for responsible partners that think and act in a similar manner on core issues.

Soelkner: Another trend affecting our industry is the ever-growing cost of bringing new drugs to market. Moving forward, biopharma companies will continue their efforts to optimize the “total cost of ownership” associated with developing and commercializing their products. This approach will lead to an increased focus on not just the function but also the value of outsourced partnerships.

As savvy service providers have discovered, biopharma companies are looking for third-party experts who do more than fill an internal skill gap or enable an in-house team to focus on core competencies. Rather, they are increasingly looking for providers who deliver a strategic, value-adding mix of specialized services, customized solutions, and efficient operations—one that spans as much of the value chain as possible. In response, there is a trend for CDMOs to actively pursue new partnerships of their own, especially between manufacturers with complementary specialties or additive skill sets. The goal is to synch expertise in ways that shorten time-to-market, accelerate technological advances, and deliver significant long-term value for customers.

CP: What are the challenges service providers like Vetter face in today’s outsourcing market?

Soelkner: As an important global sector, our industry continues to evolve, becoming more complex with the ever-changing customer and patient demands as well as increased regulatory requirements, all of which lead to a challenging environment. One way to help answering these challenges is through increased automation and digitalization which can not only support but help create even more efficient and optimized processes for the future. With increased complexity and competition, it has become essential for future-oriented companies to use modern digital solutions in order to keep pace.

In our experience, being successful with digitalization means there must be a strong commitment across all levels of the company, both within and across departments, anchored in the corporate strategy. We make a clear distinction between digital transformation and digitization: Digital transformation takes place through our employees. Our aim is to involve every employee in helping to shape and improve processes and introduce new systems. This is supported by the corresponding digitization technologies. We intend to further develop and optimize the processes in the company. Our employees drive and realize digitization through their individual mindsets. Without their participation, impactful digitization is not possible. In order to create a balance between digital technology and implementation in the company, strategic measures and constant process support are necessary. 

CP: What are your goals for Vetter over the next 12 months and beyond?

Otto: While growth is, of course, important to us, we intend to manage this growth in a sustainable manner. Currently, we face multi-faceted global uncertainties. This includes the ongoing Covid-19 pandemic as well as the Russian conflict with Ukraine, all together affecting the fields of energy supply, price increases as well as global supply chain challenges.

As a family-owned business, we are very aware of our social responsibility. As such, we think in the long-term and aim to act in an economically, socially and ecologically responsible manner. Our entrepreneurial goal is to create sustainable value which is why the implementation of a sustainability strategy was and is an integral part of our business model. This is why we just released our first Sustainability Report.

CP: Lastly, any other company news to report or anything else you’d like to comment on and let Contract Pharma readers know about?

Both: Thanks for your interest and the opportunity to cover a lot of important aspects for us and our industry in this interview. We believe all of the salient points have been made. However, we would be remiss if we did not emphasize the fact that the healthcare industry is among the most dynamic industries in the world. Companies that can manage this change by being innovative and forward-thinking will be rewarded as will the patients who have come to rely upon our industry for the life-saving medicines they need. We understand this dynamic and accept this responsibility. 

Learn more about Vetter at www.vetter-pharma.com