2025-12-16

India’s pharma industry is rapidly embracing higher sterility standards, automation and faster production cycles—and Syntegon is positioning itself to meet that shift. Tobias Gottler, Head-Strategy and Product Management Pharma Liquid, Syntegon, speaks to Akanki Sharma about the company’s high-output technologies, its push toward seamless and operator-free manufacturing, and how Syntegon is tailoring its strategy for the Indian market.

Q. What is Syntegon exhibiting this year at CPhI?

We are showcasing several key exhibits, including a compact freeze dryer designed for laboratory use and a sterility test isolator. However, the highlight this year is our tablet press. While it is not a product launch, this specific model is being displayed in India for the first time. We have showcased other models here in the past, but this one is particularly exciting because it has been engineered to meet the unique requirements of the Indian market.

Q. What makes it stand out?

Based on our experience in tablet pressing, Indian customers look for extremely high output—and this machine delivers up to 1 million tablets per hour. Additionally, many customers manage a diverse product range, so we have placed strong emphasis on quick changeover times, enabling smooth transitions from one product or tablet format to another. This is exactly why we chose to bring this model to India—to present it directly to our customers and demonstrate how it aligns with their operational needs.

Q. How has the response been so far?

So far, the feedback we’ve received on the machine has been positive. Although this is the first time we are showcasing this particular model in India, it is already well-established and in use, globally. Even though some customers in India may already be aware of this technology, we believe there is significant untapped potential in the local market. Our ambition is to continue growing and bringing advanced equipment to our customers. We recognise a strong need for this machine here, which is why we chose to highlight it prominently at this show.

Q. Syntegon emphasises on seamless processes, innovative technologies and sustainable solutions. Amid the three, which is the most under invested in the industry today in your opinion?

When we talk about Syntegon’s strengths, I would like to highlight two core themes: seamless integration and innovation.

Historically, pharmaceutical companies have had to purchase different pieces of equipment from multiple suppliers—one machine from one company, another from somewhere else. This naturally created numerous interfaces and coordination challenges. Our goal is to eliminate that complexity by offering complete, fully integrated systems where we manage all interfaces for the customer.

Let me illustrate this with our two main business areas: liquid and solid processing. In the liquid business, for instance, we recently acquired Telstar, a manufacturer of freeze dryers. Freeze dryers were the missing piece in Syntegon’s portfolio, and now, with this addition, we can provide end-to-end fill–finish lines, including the freeze dryer, as a single supplier. Customers have one point of contact, and we take responsibility for service, integration, and the entire lifecycle of the equipment.

This is exactly what we mean by seamless integration—minimal interfaces and maximum reliability.

The second major theme is innovation, driven by the increasing regulatory demands in pharma, especially around Annex 1. Compliance requirements have become much stricter, particularly for sterile manufacturing. To support our customers, we focus on developing solutions that enhance regulatory compliance and reduce human intervention. And this is only possible through close collaboration, which is why our motto is “co-create, co-succeed.” We believe innovation must be developed jointly with our customers.

Let me share a few examples. One is our settle plate changer. Traditionally, operators had to manually replace the settle plates, which meant stopping the machine and reaching in with gloves—a process that increased the risk of contamination and caused downtime. Our automated solution eliminates manual intervention entirely. The machine performs the changeover automatically, improving productivity and reducing contamination risk.

An even bigger breakthrough was launched in May this year: SynTiso, our new and revolutionary fill–finish technology. This system eliminates human interaction from the production environment. There are no glove ports, and all steps are performed autonomously by the machine. This approach not only ensures full compliance with regulatory requirements, but also delivers significantly higher output.

Together, these innovations reflect our commitment to helping pharmaceutical companies meet rising regulatory expectations while achieving safer, more efficient and more automated production.

Q. You highlighted regulatory pressures as one of the major challenges. Besides that, do you see any other challenges that the industry faces?

Aside from Annex 1–related regulatory pressures, we see two major drivers shaping the industry today. The first is the shift from traditional bulk glass production to ready-to-use (RTU) containers. This trend is particularly important for India, where many CMOs rely on fast changeovers and the ability to switch quickly between products. RTU containers make this process much easier, allowing seamless transitions between vials, syringes and cartridges. To support this shift, we offer a comprehensive portfolio tailored to the needs of Indian manufacturers.

The second key trend—closely linked to Annex 1—is the growing demand for isolator technology. Previously, many companies relied on Restricted Access Barrier Systems (RABS), but the industry is now steadily transitioning toward isolators for higher sterility assurance. Anticipating this need, Syntegon invested in its own isolator manufacturing capability over 20 years ago. As a result, we can now provide fully integrated solutions that combine fill–finish equipment, isolators, and lyophilizers within one seamless system—an offering that strongly differentiates Syntegon in the market.

Q. Since the Indian market is expanding so rapidly, do you see strong opportunities to implement the solutions you mentioned here and beyond?

Yes, we are already working on it. We have several lines in India equipped with isolator technology and the latest innovations. So, these solutions are already being implemented here.

Moreover, we operate globally. While our base is in Germany, more than 80–90 percent of our production is exported. We supply to Europe, the US, India, China, Japan and many other regions.

Q. Does Syntegon use tools like digital twins, AI / ML in its manufacturing processes or systems?

Digital twins are increasingly in demand from our customers. What we see in the market is that clients want a virtual model, not just of a single production line, but of their entire factory. This requires integrating all data and establishing clear interfaces with the customer’s digital twin technology. In some projects, we even deliver the digital twin before the machine itself, allowing the factory to prepare in advance. This capability is evolving and is tailored to the needs of each customer.

Regarding AI and ML, yes, we do incorporate these technologies in our inspection machines. These machines check filled containers for leaks, cracks, or foreign particles, ensuring the highest quality before products reach the market. By using deep learning models, the machines improve their inspection accuracy over time and reduce the number of false rejects. This gives both manufacturers and end-users confidence that every product, particularly injectable medications, meets stringent quality standards.

Q. Since we’re discussing technology, could you highlight some trends emerging rapidly over the next three to five years that could transform the industry?

One trend we definitely expect to grow is in oncology. We closely monitor our customers’ pipelines, and many are focusing on cancer therapies. While these products are crucial for patients, they can be highly toxic for others, which creates unique challenges in fill–finish production.

It’s not just about maintaining sterility; high-potency production also requires protecting the operator from exposure. This therapy area is expanding rapidly, and we’re seeing an increasing number of projects. We already have solutions in place, but as the field grows, it will demand more advanced features and technologies to ensure both product safety and operator protection.

As demand grows, these technologies will continue to evolve.

For example, our SynTiso platform is designed to progressively remove the operator from the operation, which improves sterility and enhances operator safety. One long-term vision for pharmaceutical production is ‘lights-out’ manufacturing, where no people are present in the production area. Robots and automated carriers would handle tasks like moving empty containers, and the filling process would be fully automated. While this is still a long-term goal, I believe the industry is moving steadily in this direction over the next 15-20 years.

Q. That brings me to another point—in such highly automated systems, cost can become a major factor and potentially a challenge for many players in the industry. How do you see this impacting adoption?

I believe this is a common trend with any new technology. Initially, costs are higher due to development efforts and limited production scale. However, as more customers adopt the technology, economies of scale in manufacturing and supply chains bring the prices down. Another important aspect is supply security. Ensuring sufficient medicine reaches the market is critical, and currently, the biggest risk in fill–finish production comes from the operator, who can inadvertently compromise sterility. By reducing operator intervention, not only is sterility better maintained, but the number of batches supplied to the market can also increase, helping to offset the initial higher costs of automation.

Q. Could you share Syntegon’s future expansion plans in India and other international markets?

Generally, Syntegon is focused on growth across all markets, with India being a key priority. Over 20 years ago, the company established a subsidiary in India to serve this important market. Additionally, Klenzaids Contamination Controls, an Indian company within the Syntegon Group, is part of this growth strategy.

Syntegon is also expanding its presence through a development and engineering hub in India, staffed with a significant number of highly qualified engineers. This team collaborates with Syntegon’s global sites, supporting operations in Europe, the US, China and beyond, while simultaneously helping to grow the company’s production and business footprint in India.

Q. Is there anything you would like to highlight that needs attention at the moment?

For us, partnering with our customers is of utmost importance. We aim to be a lifecycle partner, supporting a project from inception to ramp-up of a production line. However, our focus goes beyond merely selling machinery. In line with our slogan “co-create, co-succeed,” we work closely with customers during the development phase to understand their needs, identify the right solutions, and help grow their business in the pharmaceutical industry.

Once the machinery is operational, we continue to support our customers to maximise efficiency, reduce downtime and achieve the highest OEE rates. We invest in training local service technicians in every country to ensure rapid troubleshooting and maintain critical spare parts in stock. In such a critical industry where patient care depends on timely delivery of medicines, ensuring that our equipment performs reliably is paramount.