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Lyophilization
Lyophilization is critical in maintaining the efficacy and stability of pharmaceuticals and biological materials throughout their lifecycle, making these products more widely available and usable. But this transformative technology requires careful process optimization to ensure uniformity, consistency, and efficiency and to avoid pitfalls such as long cycle times and quality control issues.
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Solutions For Lyophilization
Ascential offers expertise in handling lyophilized beads which harness the power of freeze-drying to extend product shelf life while maintaining optimal efficacy. Additionally, our extended team can assist in the development of cartridges and complex instrumentation to fully commercialize the advancements that lyophilization offers. This innovation unlocks new possibilities in drug development, transportation, administration, and testing.
Process Optimization
Achieving optimal lyophilization conditions for a specific product can be challenging. Factors such as freezing rate, shelf temperature, and pressure need to be carefully controlled to ensure efficient drying and reconstitution without compromising product stability. Our consultants work with you to design and manufacture tailored instruments, cartridges, and processes to meet your unique needs.
Scalable Solutions
Transitioning from laboratory-scale lyophilization to large-scale production introduces challenges related to maintaining process uniformity, consistency, and efficiency. Our experts understand this transition and can work with you to adjust your equipment design and process parameters to be commercial-ready.
Ongoing Design and Maintenance
The design and maintenance of lyophilization equipment are crucial for achieving reproducible results. Regular maintenance and calibration are necessary to ensure the equipment operates within specified parameters. Our experts work with you at any phase of development and delivery to ensure your ongoing success.
Managing Energy Consumption
Lyophilization is an energy-intensive process, making it important to optimize energy consumption and manage environmental concerns. Our experts work with innovations in lyophilizer design and process control to deliver the most stable, high-quality products that leverage more sustainable processes.
Validation and Regulatory Compliance
Validating the lyophilization process and ensuring consistent product quality are essential for regulatory compliance. Our team works with you to design robust quality control measures to monitor critical process parameters and product attributes to ensure the highest quality standards are met.
Reducing Cycle Times and Cost
Our team understands the importance of balancing cost, efficiency, and quality. Lyophilization processes can have long cycle times and be costly without the right manufacturing expertise. Ascential delivers maximum efficiency without compromising quality and product stability.
