Dear Experts,

Welcome to Tempris. With over 15 years of experience and over 200 customer projects worldwide, we offer a unique lyophilization technology that enables at least 25% process efficiency gain*. What this means for you and your company is: lower costs, shorter development and production times, and optimized planning from development to market approval.

Our wireless sensors, which enable automated, sterile handling, and our innovative LyoCLC closed-loop control software work seamlessly together. LyoCLC uses AI and machine learning with an algorithm that accurately predicts the endpoint of primary drying based on real-time process data. This enables data to be analyzed at every stage, from process development to the end of the product life cycle. Deviations are detected in good time, and the system provides appropriate corrections directly to the control system.

During a Tempris presentation followed by a panel discussion at IFPAC 2023, our technology was identified by experts and FDA inspectors as the ‘low hanging fruit’ – the solution that is quickest and easiest to implement and that can be used to achieve significant improvements with little effort. This motivated us to further develop our LyoCLC software in 2024 in an even more targeted way.

Anton Mangold
Managing Director Tempris GmbH Holzkirchen, Germany

Since innovative active ingredients such as ADCs and mRNA vaccines are unstable in liquid form, 50 to 60% of biopharmaceutical products such as proteins, antibodies, and vaccines are freeze-dried. This is a complex,

costly, and time-consuming process that requires efficiency and quality. The FDA has recognized this need and launched the Advanced Manufacturing Technologies Designation Program (AMTs) in December 2024. This promotes technologies that accelerate the availability of drugs to patients. Technologies like Tempris, which have the potential to improve process efficiency significantly, are real game-changers.

We support your company in effectively and innovatively addressing the enormous challenges you face. Amgen CEO Bob Bradway’s statement ‘Innovate or Die’ shows the path the industry must take to identify innovative active ingredients and bring drugs to market faster with shorter development time.

Our team of experts will be happy to advise you and show you how to make lyophilization processes faster and more precise and bring new drugs to market more efficiently and economically.

We look forward to working with you!

Anton Mangold

*Compared to a non-optimized conservative cycle