Continuous Manufacturing of Pharmaceuticals

tablets-in-pharmaceutical-continuous-manufacturing

Continuous manufacturing of pharmaceuticals is changing oral solid dosage (OSD) production. Higher flexibility, shorter development times with minimum API usage, and a direct transfer from development to production without scale-up are among the primary requirements of pharmaceutical manufacturers. In pharmaceutical manufacturing, the processes occur one after the other without interruption while the product is charged and discharged simultaneously. The main challenge with traditional solutions is the precise dosing of the starting materials in a constant mass flow rate of milligrams per second.

Syntegon is tackling the challenges in continuous manufacturing pharmaceuticals with a different approach, called Xelum.

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Key benefits

Low API dosage, high accuracy

You can precisely dose APIs of less than 1% while ensuring high content uniformity for your final product.

Your shortcut to production

Thanks to a direct transfer from R&D to production, you don’t require scale-up.

We care for quality

The Xelum platform supports you with easy and reliable quality control as well as integrated traceability.

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Your gateway to continuous manufacturing

Shorter time-to-market of new formulations? No scale-up? Full flexibility in batch sizes and processes? Cost reduction? Xelum checks all boxes! No wonder that bluechip companies on three different continents have signed strategic partnerships for the Xelum continuous manufacturing system with Syntegon. Learn more in our video.

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Continuous Manufacturing from Syntegon: Xelum

Continuous manufacturing is changing oral solid dosage (OSD) production. Higher flexibility, shorter development times with minimum API usage, and a direct transfer from development to production without scale-up are among the primary requirements of pharmaceutical manufacturers.

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Why choose continuous manufacturing?

Watch the video to learn more.

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OSD: Many facets – one partner

Oral solid dose (OSD) manufacturing is a demanding endeavor. There is no better partner to tackle those tasks with than Syntegon. Our OSD services and process technology will make your production a rock-solid success. Find out more in this video.

The Xelum platform doses active ingredients and excipients as discrete masses and not as a continuous mass flow. This way, even smallest amounts of APIs of less than 1% can be dosed precisely. The system doses, mixes and granulates individual packages, so-called X-keys, which continuously run through the process chain and are discharged successively as granules, tablets, or capsules.

Unique and proven technology

The Xelum platform is based on the robust and proven fluid bed processors that Syntegon has been refining for over 30 years. They cover granulation and drying in the same process chamber. This eliminates the need to transfer wet granulate, benefitting the system’s reliability. Xelum achieves high granulation yields with the desired characteristics – including unimodal particle size distribution, as well as excellent flow and tableting properties. The platform further ensures lower production costs and high flexibility. The same holds true for the Xelum R&D and pilot unit, your point of entry into continuous manufacturing.

continuous-manufacturing-platform-Syntegon-Xelum

Xelum R&D

Our Xelum R&D is your ideal start into continuous manufacturing.

Since it uses exactly the same components as the Xelum production platform, process parameters can be directly transferred 1:1 without scale-up. This is valid for dosing, blending, and granulation. You can develop formulations for both batch and continuous manufacturing on the same machine, starting from 250 g. Xelum R&D can run clinical trial and pilot batches at a rate of 10 kg/h. The user-friendly controls of the system is complemented by a practical, automated DoE support. As a fully contained unit, it is also perfectly suited for the development of high potent APIs.

Xelum-continuous-manufacturing-of-pharmaceuticals

Xelum production line

If you are looking for a continuous production line with a small footprint, flexibility and fast product changeovers, look no further!

Our Xelum production unit uses only 1/3 of the production space of a comparable batch production, saving important cleanroom space, reducing energy costs drastically. The modular set-up allows you to integrate tableting and capsuling. Next to fluid bed granulation also other processes like direct compression are possible. All process parameters can be transferred 1:1 from the Xelum R&D since both machines share the exactly the same components. This eliminates the need for time and cost-intensive scale-up. With a nominal throughput of 30 kg/h, it is an ideal companion for your pilot and production-scale manufacturing.

Features of our continuous manufacturing technology

Our simplified process concept includes smart controls that keep your process within specification. They eliminate the need for complex measurement technology while ensuring consistently high product quality.

The Xelum platform facilitates precise dosing of even the smallest amounts of active pharmaceutical ingredient (API). Our innovation allows you to run robust processes with minimized start-up and shut-down losses, resulting in high yields. All individual product packages, so-called X-keys, are within specification – from the very first to the very last.

Xelum allows you to save time and drastically cut costs, as direct process transfers from R&D to production don’t require scale-up.

X-keys stay fully separated from each other before they reach the tablet press or capsule filling machine. Each X-key has its own fingerprint, linking the final product with all critical process parameters, critical quality attributes and raw material lot numbers.

The design of our equipment is based on a thought-through cleaning concept from the very beginning. The automated cleaning process enables for fast cleaning in only one shift.

Use case scenarios

Outstanding granule quality

Whether you compress granules into tablets or fill them into capsules or sachets, e.g. for nutraceuticals – our Xelum achieves outstanding quality for any dosage form.

Tablets at their best

Outstanding granule properties like smooth flowability and an ideal particle size distribution result in excellent compression characteristics – even at very low API concentration, e.g. for cancer therapy.

Yes we capsule

Granules, pellets and mini tablets are perfectly suitable for fixed-dose or personalized combination capsules, e.g. anti-infective drugs. Our Xelum ensures optimum quality of the individual components.

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Technical data of our continuous manufacturing technology

up to

footprint reduction compared to regular pharmaceutical plant

starting at

minimum product amount

up to

kg/h throughput

APIs of less than

can be dosed precisely

Technical data overview

	Xelum R&D scale, Pilot scale	Xelum Production scale
Nominal throughput (kg/h)	0.25 to 10	30
At a density of (kg/l)	0.5	0.5

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Digital Solutions

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Parts

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Maintenance

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Technical Support

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Modernizations

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Training

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About us

Oral solid dosage forms (OSD) are our specialty: in the course of our long business history, we have supported countless industry players across the globe and shared our rich expertise in tablet coating. As an innovation-driven company, we are far from maintaining the status quo: over the last few years, we have been actively pursuing new ways to advance OSD manufacturing. Download our selection of brochures to find out more.

Learn more about our Pharma Services (OSD)

already signed strategic partnerships with blue chip companies

years of expertise

installed base worldwide

locations

Syntegon enters strategic parnership with Bayer

The cooperation is based on the Xelum platform developed by Syntegon's subsidiary Hüttlin, which both partners intend to advance together and establish as a standard for continuous production in the pharmaceutical industry.

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Shanghai Pharmaceuticals and Syntegon partner to promote continuous manufacturing in China

Shanghai Pharmaceuticals and Syntegon have signed an agreement to build a laboratory for continuous manufacturing technology in China. The cooperation will promote the application of this new technology, shorten development cycles of new drugs, reduce the cost of drug development, continuously improve the accessibility of new (especially orphan) drugs in China, and create more value for patients.

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