Every pharmaceutical product demands precise process parameters to ensure quality throughout its shelf life. The FDA report "A Regulatory Perspective on Manufacturing Processes Pertaining to Lyophilized Injectable Products" from Steve Y. Rhieu, David D. Anderson, and Kumar Janoria reveals that over half of regulatory approval deficiencies stem from inadequate freeze-drying cycle development.
Development studies must identify the critical temperatures of the drug formulation. Failure to provide sufficient data often results in approval deficiencies. Once these critical formulation temperatures are determined, applicants must also establish freezing and primary drying process parameters and ensure equipment performance.
A common shortfall is the inaccurate determination of the primary and secondary drying endpoints, which can lead to potential quality issues. Tempris offers a solution by delivering precise measurements and real-time data, enabling exact endpoint determination and preventing approval deficiencies.
Tempris is the key to faster and more efficient approval of lyophilized drugs by providing all necessary freeze-drying data for regulatory clearance. This can shorten the approval process by 6 to 8 months. Tempris's advanced sensor technology offers comprehensive monitoring of critical process parameters, enabling pharmaceutical companies to meet stringent regulatory requirements more quickly and accurately.
Delivering All Regulatory Data
One significant advantage of the Tempris system is its comprehensive collection and provision of all relevant data necessary for drug approval. Tempris delivers accurate real-time temperature data and continuously monitors critical process parameters such as product temperature, shelf temperature, and chamber pressure. This precise data collection and monitoring ensure that all required information for approval can be generated without additional effort or process interruption.
Accelerating Market Approval by 6 to 8 Months
By providing complete and validated data, Tempris supports process optimization and reduces the risk of deficiencies in regulatory submissions. This significantly reduces time to market, as potential issues can be identified and addressed early. Pharmaceutical companies benefit from an accelerated market entry, giving them a crucial competitive advantage.
Optimizing In-Process Control Strategies
Tempris enhances pharmaceutical companies' in-process control strategies with state-of-the-art measurement technology specifically designed for the commercial production of lyophilized drugs. With Tempris, companies can precisely determine the primary drying endpoint, which is crucial to preventing quality issues such as product collapse or melting. The ability to capture temperature data at multiple points on all shelves within the freeze-drying chamber ensures uniform temperature distribution and production consistency.
Managing Critical Process Variables
Lyophilization is a complex process with many variables at 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
Every pharmaceutical product requires specific process parameters to ensure the desired quality throughout its shelf life. Tempris ensures these individual requirements are met by continuously delivering accurate and reliable data. This results in improved quality and reproducibility of production outcomes, which is crucial for commercial manufacturing.
Benefits of the Tempris System:
· Complete Provision of All Regulatory Data: Enables faster and more precise fulfillment of regulatory requirements.
· Reduction of Development and Approval Time by 6 to 8 Months:This speeds up market entry through more efficient process control.
· Optimization of In-Process Control Strategy: Strengthens process monitoring and prevents quality issues during freeze-drying.
· Precise Determination of the Primary Drying Endpoint: Prevents issues such as product collapse or melting.
· Capture of Temperature Data at Multiple Points: Ensures uniform temperature distribution and consistent production outcomes.
· Management of Critical Process Variables: Supports the resolution of challenges like choked flow and condenser overloads.
· Improved Quality and Reproducibility:This ensures that each drug's individual requirements are met and quality remains consistent.
With Tempris, pharmaceutical companies can optimize the approval process, efficiently provide all necessary data, and bring their products to market faster.
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