바이오로직스 자료
Enhancing biopharmaceutical stability through lyophilization
Lyophilization plays a pivotal role in stabilizing liquid drug products, requiring specialized expertise and advanced capabilities to address its complexity. This whitepaper highlights how Samsung Biologics' optimized lyophilization processes, including large-scale equipment and automated systems, help partners achieve reliable and high-quality freeze-dried products. Read more
Technology-driven innovations in lyophilization
Due to stringent regulatory standards in the pharmaceutical industry, recent advancements in lyophilization have primarily focused on enhancing equipment performance and simplifying processes. Innovations in automation now enable fully automated loading, stoppering, and unloading of vials, minimizing human intervention and potential contamination. Modern lyophilizers are also equipped with numerous built-in sensors, providing real-time monitoring and control to improve consistency and precision. Additionally, equipment manufacturers have developed energy-efficient solutions to address the traditionally high energy demands of freeze-dryers and align with sustainability goals.
Artificial intelligence (AI) is also expected to play a transformative role in the lyophilization of biologic drugs, including monoclonal antibodies, mRNA vaccines, and advanced multi-specific modalities. One of the earliest applications of AI will be in predictive maintenance. It is critical to keep lyophilizers operational because of their costs and the essential role they play in production. AI-driven systems under development could monitor subtle changes, such as variations in chamber vibrations, to predict when preventive maintenance is needed. These proactive approaches go beyond current preventive maintenance practices, allowing for timely intervention before issues arise
Comprehensive drug lyophilization services
Several critical factors should be considered when selecting a CDMO partner for lyophilization to ensure the process meets rigorous quality and efficiency standard. In this whitepaper, we explore the importance of the following five attributes for quality lyophilization services:
- Process expertise
- Automation and quality control
- Capacity and equipment scalability
- Regulatory compliance and quality standards
- Redundancy and reliability
Lyophilization plays a pivotal role in stabilizing liquid drug products, requiring specialized expertise and advanced capabilities to address its complexity. This whitepaper highlights how Samsung Biologics' optimized lyophilization processes, including large-scale equipment and automated systems, help partners achieve reliable and high-quality freeze-dried products. Read more
Technology-driven innovations in lyophilization
Due to stringent regulatory standards in the pharmaceutical industry, recent advancements in lyophilization have primarily focused on enhancing equipment performance and simplifying processes. Innovations in automation now enable fully automated loading, stoppering, and unloading of vials, minimizing human intervention and potential contamination. Modern lyophilizers are also equipped with numerous built-in sensors, providing real-time monitoring and control to improve consistency and precision. Additionally, equipment manufacturers have developed energy-efficient solutions to address the traditionally high energy demands of freeze-dryers and align with sustainability goals.
Artificial intelligence (AI) is also expected to play a transformative role in the lyophilization of biologic drugs, including monoclonal antibodies, mRNA vaccines, and advanced multi-specific modalities. One of the earliest applications of AI will be in predictive maintenance. It is critical to keep lyophilizers operational because of their costs and the essential role they play in production. AI-driven systems under development could monitor subtle changes, such as variations in chamber vibrations, to predict when preventive maintenance is needed. These proactive approaches go beyond current preventive maintenance practices, allowing for timely intervention before issues arise
Comprehensive drug lyophilization services
Several critical factors should be considered when selecting a CDMO partner for lyophilization to ensure the process meets rigorous quality and efficiency standard. In this whitepaper, we explore the importance of the following five attributes for quality lyophilization services:
- Process expertise
- Automation and quality control
- Capacity and equipment scalability
- Regulatory compliance and quality standards
- Redundancy and reliability