Revolutionary Tempris System can speed up Regulatory Approval for Lyophilized Drugs

Holzkirchen, Bavaria, Germany: Temperature monitoring pioneer Tempris GmbH says its innovative wireless temperature sensors can make a huge contribution to speeding up drug regulatory approval. This is because precise temperature control in lyophilization freeze-drying processes play such a key role in determining pharma product quality and shelf life.

This is underlined by a US Food & Drug Administration (FDA) regulatory study on manufacturing processes for lyophilized injectable products (Rhieu, Anderson and Janoria, 2020), which concludes that more than 50 per cent of regulatory approval deficiencies for injectables can be attributed to inadequate freeze-drying cycle development.¹

Data gap

These approval deficiencies often stem from failure to provide sufficient process data. After development studies have determined the critical temperatures of the drug formulation, the regulatory application must also establish freezing and primary drying process parameters and ensure equipment performance.

A common risk to product quality is inaccurate determination of the primary and secondary drying endpoints. State-of-the-art Tempris measurement technology now allows manufacturers to determine endpoints precisely, preventing quality issues such as product collapse or melting.

Ability to capture temperature data at multiple points on all shelves within the freeze-drying chamber ensures uniform temperature distribution and production consistency. The Tempris system can collect all relevant lyophilization data necessary for drug approval from first batch, accelerating marketing approval of lyophilized drugs by up to eight months.

Delivering to regulators

As well as delivering accurate real-time data on actual product temperature in the freeze-drying chamber, the Tempris system can also enhance pharmaceutical companies’ in-process control strategies by continuously monitoring critical parameters such as shelf temperature, and chamber pressure.

This precise data collection and monitoring allows all required information for approval to be generated without additional effort or process interruption and supports process optimization. This further reduces time to market by allowing potential issues to be identified and addressed early, handing pharma companies significant competitive advantages.

Optimized In-Process Control

Lyophilization is a complex process with many variables in play. The loading condition of the freeze-drying chamber, whether fully or partially loaded, significantly impacts the process. Tempris helps tackle challenges such as choked flow and condenser overloads by enabling accurate monitoring of these critical process variables.

Enhanced Quality and Reproducibility

Tempris temperature monitoring ensures that specific lyophilization process parameters required to ensure pharmaceutical product quality throughout its shelf life can be demonstrated by continuously delivering accurate and reliable data. This also results in improved quality and reproducibility of production outcomes that are crucial in commercial manufacturing. The Tempris system thus offers a series of powerful benefits:

• Complete Provision of All Regulatory Data: for faster and more precise fulfillment of regulatory requirements.
• Reduced Development and Approval Time: More efficient process control and data collection can speed up market entry by 6 to 8 Months.
• Optimized In-Process Control Strategy: Strengthened process monitoring prevents quality issues during freeze-drying.
• Precise Determination of Primary Drying Endpoint: Avoids issues such as product collapse or melting.
• Multiple Point Temperature Data Capture: Ensures uniform temperature distribution and more consistent production outcomes.
• Management of Critical Process Variables: Supports the resolution of challenges such as choked flow and condenser overloads.
• Improved Quality and Reproducibility: Ensuring that each drug’s individual requirements are met for assured consistent quality.

With Tempris, pharmaceutical companies can optimize the approval process, efficiently provide all necessary data, and bring their products to market faster.

Reference

1. Rhieu, S.Y., Anderson, D.D. and Janoria, K. (2020). A Regulatory Perspective on Manufacturing Processes Pertaining to Lyophilized Injectable Products. The AAPS journal, [online] 22(5), p.100. doi:https://doi.org/10.1208/s12248-020-00477-6.

About Tempris

Founded in 2008 and based at Holzkirchen in Bavaria, Tempris GmbH has become a leading innovator in real-time temperature measurement and monitoring. Its revolutionary wireless and battery-free quartz-based temperature sensors and software form the basis for a Process Analytical Technology (PAT) tool to streamline lyophilization processes by providing real-time, accurate, and reliable temperature data of unparalleled accuracy and reliability.

The Tempris brand strapline: ‘Easify your Lyo Process’ encapsulates its mission to automate and optimize freeze-drying processes by enabling real-time product temperature monitoring during process. It is collaborating with academia and leading names in the industry to apply this technological advance to unlock full automation and major productivity gains in lyophilization.

Tempris has developed product and service streams in development & manufacturing, process control applications, software development, and implementation support.

From its headquarters south of Munich, Tempris has added distribution partners in Europe, Asia and the USA and has become ISO 9001 certified for quality management systems, as well as ISO 14001 for environmental management and sustainability, with all products designed and engineered to comply with applicable regulations, such as GAMP 5 guidelines and FDA 21 CFR Part 11 / EU GMP Annex 11 for compliance of IT systems.

Learn more at: https://www.tempris.com

Resources

Click on Real Time Product Temperature Monitoring in Freeze-Drying to learn more.