Bayer chooses INJECTA for the production of parenteral medicines.

In exclusively for Process Worldwide

November 2023 saw the inauguration of a new Bayer AG facility located in Berlin and dedicated to producing parenteral medicines. In the context of a billion-dollar investment program which aims to boost the company’s pharmaceutical production capabilities and bring medicine from concept to market even faster in the future, Bayer needed to be able to count on latest-generation technologies, high-performance equipment and the reliability of a consolidated player in the market. The choice fell on IMA Life with its fully robotic, aseptic, fill-finish solution: INJECTA.

The three key objectives

Taking a closer look at the reasons Bayer selected IMA, we should start by identifying the main objectives. The customer wanted to achieve an in-house pipeline with the following aseptic processing capabilities: vials, syringes and pre-capped cartridges, for liquid and lyo formulations, involving both small and large molecules.
Furthermore, it was strategically important to accelerate the lead times, so that each medicine was able to reach patients as fast as possible. This meant avoiding the need to transfer anything related to production between clinical phase 3 and product launch. Agile production was also a key factor at late-stage clinical, launch and commercial supply phases.
Last of the three key objectives can be defined as “fit for future”. Bayer attached enormous importance to those future-oriented aspects that will make the difference for years to come. The customer was looking for the most advanced technology, one in which robotics had replaced the need for human intervention. A system able to generate data that could be integrated seamlessly with Bayer’s analytical system. The customer wanted digitalization and paperless production.

The top priorities

Closely linked to the objectives set by Bayer, the priorities included flexibility, to such a degree that the technology on which the solution was built could handle almost all parenteral dosage forms (liquid, lyophilised, frozen, aseptic, terminally sterilised).
The solution had to be scalable, able to process anything from a single tub up to 70,000 containers. This factor, in particular, supported the company’s need to maintain production on the same machine, whether processing single, pre-launch batches or commercial production runs.
Thirdly, the solution needed to be “cosmopolitan”, ensuring availability worldwide for the medicines processed on the line. This meant the need for a data highway with end-to-end data availability in a paperless form, an integrated production line in the context of a predictive plant where machine sensors would forewarn of malfunctions and avoid them in time. A key demand was the ability to feed raw data into Bayer’s system that could be analysed using the customer’s algorithms.

Making the decision

The decision to opt for INJECTA only came after lengthy analysis of the potential alternatives. The factors which led Bayer to choose IMA Life technology are several. There are countless criteria involved and they can be grouped into 3 categories according to the type of analysis.

Pareto analysis identified the following plus points for INJECTA:

• Precision in the transfer of objects inside the machine, without object-to-object contact.
• No or minimal obstruction of first air over open objects. In this case IMA Life’s ability to establish the results of a CFD analysis were crucial proof of achieving this criterion.
• Ability to ensure single-object filling and outfeed.
• Zero manual intervention (except for troubleshooting). Here the advanced robotic technologies implemented by IMA Life together with partner Kawasaki, who has developed special robots for IMA’s aseptic processing equipment, demonstrated the future-oriented, “toward gloveless” approach adopted by IMA Life.
• Biotrack implementation for future real-time monitoring and ongoing automatic inspection for particulates with real-time feedback.
• Ability to verify accuracy of scale before initiating the filling process. • Zero sensor adjustments when the format changes.

Value benefit analysis pointed clearly in the direction of IMA Life’s solution, underlining yet again the precision transfer with zero object contact, the absence of first air over open objects, single filling and outfeed, virtually gloveless processing and the ability to provide continuous filling operations.
Risk analysis evaluated key issues which needed to fit perfectly with Bayer’s objectives. IMA Life was found to be an excellent partner, willing to share knowledge and find appropriate solutions. Moreover, it was established that as a supplier, IMA Life had a reliable track record and extensive experience in the field of robotized, commercial fill-finish lines. A vital factor was IMA’s ability to fit in with Bayer’s ambitious timeline, and taking just 12 months from FAT to Qualification Completion proved the point.
In conclusion, IMA scored higher than any other potential supplier in these 3 analytical categories, so Bayer chose INJECTA.

Pinpointing the key benefits of the IMA Life solution

Bayer picked 6 points to award IMA with its preference. Flexibility of the concept, making any future evolutions easier to address. INJECTA was welcomed for its excellent accessibility and the ergonomics of its design. Re-nesting capabilities were seen as a key factor; in fact, the solution provided enabled customised, external re-nesting of RTU materials.
The customer appreciated the minimal need to intervene in any way if future options were required for the machine. Huge importance was placed on integration into Bayer’s data analytics system as this meant a significant ability to manage key processing data and monitor product quality at all times.

Last but not least, IMA Life was considered a valued partner in all phases of the project, including validation support.

Top technologies and true partnership

Due to enter into production mid-2024, more information will be available to back the choice made by Bayer to entrust such a vital part of its new production line to IMA Life.
Until now, the technology at the heart of INJECTA stands ahead of rival solutions, but what also helped clinch the business with Bayer AG was IMA Life’s ability to bond with the customer’s team, share their goals, fit in with their timeline and deliver the results they were looking for. Recently, Sven Filler, Strategic Investment Program Manager with Bayer AG, praised the IMA Life team in writing: “This is a great success thanks to your strong, sustainable, solution-oriented and excellent accomplishment.”