2024-07-25

Q: Tell us about Syntegon key offerings related to pharma industry and how does its products distinguish itself from its global competitors?

Dr. Andreas Mattern: Syntegon offers its customers solutions for the development and production of both liquid and solid dosage forms along the entire value chain – from lab to global scale, so to speak. Our portfolio in both areas comprises seamless processes, innovative technologies, as well as life cycle sustainability and services from a single source.

An example is the development and production of oral solid dosage forms (OSD). Our portfolio covers all the most important trends: from continuous manufacturing to production in ever larger batches. This includes mixing, drying, granulation, coating, and of course also tablet pressing and capsule filling. With the OSD Customer Service Centers, we have global network of customer centers and partner laboratories that provide support in the development of OSD products and corresponding manufacturing processes.

Q: What technologies does Syntegon offer for liquid pharmaceutical processing?

Dr. Andreas Mattern: Just like with OSD products, we also have the entire equipment and service portfolio for liquid pharmaceuticals and biopharmaceuticals. This ranges from pure media and processing systems, including our brand-new modular bioprocessing platform MBP, to freeze dryers and sterilizers, fill-finish equipment with isolators, inspection technology, and assembly systems for pens and auto-injectors.

Whatever pharmaceutical manufacturers and contract development and manufacturing organizations (CDMOs) need, Syntegon can offer seamless line solutions including comprehensive life cycle services across the entire value chain. Our goal is to co-create and co-succeed in close partnership with our clients so that they can bring their life-saving medicines to the market as quickly, efficiently, and safely as possible.

Q: What prompted Syntegon to expand its pharmaceutical processing and packaging business and was there any specific reason to acquire Azbil Telstar?

Dr. Andreas Mattern: Telstar is a significant addition to Syntegon’s portfolio for liquid pharmaceutical processing. Telstar has a strong experienced team serving pharma, life sciences, and medtech customers around the world, especially in Southern and Western Europe, the U.S., and India. Freeze-dryers as well as loading and unloading systems including comprehensive services are the most important portfolio enhancements for Syntegon and ideally complement its leading vial filling and isolator solutions.

With the expanded portfolio, Syntegon will be in an even better position to offer both pharmaceutical manufacturers and CMOs seamless line solutions from a single source. Moreover, the Syntegon service network will be expanded significantly by the Telstar service engineers, adding geographical coverage, proximity, and application expertise. Telstar's business will of course also benefit from its integration into the Syntegon Group with its complete solutions for pharmaceutical processing and packaging technology.

Q: What advantages will pharmaceutical manufacturers and CMOs gain from Syntegon's expanded portfolio?

Dr. Andreas Mattern: Syntegon’s customers will benefit from even more comprehensive solutions, seamless processes, and life cycle services. At the same time, we will jointly capture growth opportunities and expand our market presence. However, Syntegon is not only expanding its offering for pharmaceutical manufacturers and CMOs through this acquisition. We are also doing this through new technological developments, as we demonstrated at Achema in Frankfurt, Germany, this June.

For example, with the new modular bioprocessing platform (MBP), we now also offer biopharmaceutical manufacturers seamless and complete solutions along the entire production chain. The innovative design of the MBP allows customers to profit from shorter lead times and lower costs, without compromising on quality. The MBP is a highly flexible, fully integrated and automated solution for biologic drug substances, which answers the most pressing challenges in biopharmaceutical production.

Another market launch is highly important for aseptic filling processes in accordance with the EU GMP Annex 1, which came into effect in August last year and must be complied with by both European manufacturers and CMOs as well as those wanting to import their products into the European Union. The new patented Settle Plate Changer (SPC) from Syntegon for automated viable monitoring uses automation to reduce the time needed to replace settle plates – resulting in noticeably higher machine availability of up to 300 hours per year.

Q: How does Syntegon address regulatory and quality compliance requirements in its pharmaceutical manufacturing solutions?

Dr. Andreas Mattern: As a partner to our customers, we work closely together to comply with all regulatory requirements. For instance, Syntegon’s new technologies are of course designed with the new EU GMP Annex 1 in mind. In the case of older machines, the question is whether to upgrade or invest in a completely new line with pre-installed barrier technology. Syntegon offers both options and analyzes customer requirements in detail to recommend the ideal solution to become “Annex 1-ready”. The numerous RABS upgrades offer customers an extensive choice of options, including peripheral topics such as viable monitoring, new stopper infeed solutions, or glove integrity testing devices.

We have a large team of experts in all regulatory and quality compliance fields. Our subsidiary Valicare has more than 20 years of experience in regulatory and GMP compliance, including qualification and validation, GMP for ATMPs.

Q: How does Syntegon ensure the continuous flow of data in its pharmaceutical manufacturing solutions?

Dr. Andreas Mattern: Syntegon has developed a special, cloud-based software solution for pharmaceutical manufacturing operations. Synexio enables the collection, evaluation, and visualization of machine and production data, as well as component monitoring. Synexio is part of Syntegon's Service Agreements, which form the basis for effective equipment and maintenance management at fixed prices.

Moreover, we have developed several new digital solutions for pharmaceutical filling. For example, the intelligent piston pump “Smart Pump” from Syntegon carries its memory with it on an RFID chip, even when it is not installed in the machine. The system automatically recognizes the pump, for example after cleaning – which significantly increases process reliability, reduces human error, and saves a lot of time in ongoing production. The entire “Max Pro” portfolio for liquid filling is designed for less product loss and hence higher yields. For example, the optional twin fill process enables the optimal determination and readjustment of the filling weight via main and secondary dosing with 100% in-process control.