Bora Biologics provides a state-of-the-art, GMP/GDP-compliant storage infrastructure meticulously designed to meet the stringent requirements of the pharmaceutical and biologics industries. We offer a comprehensive suite of temperature-controlled storage environments tailored to the unique needs of raw materials, intermediates, and finished products. These include:

• Controlled Ambient Storage: Maintained at 15–25°C, ideal for general raw material storage.
• Refrigerated Storage: Dedicated cold rooms maintained at 2–8°C, essential for temperature-sensitive biologics and Active Pharmaceutical Ingredients (APIs).
• Frozen Storage: Offering a range from -20°C to -70°C for highly sensitive or specialized materials, including monoclonal antibodies.
• Cryogenic Storage: Temperatures down to -150°C and lower for cell bank.

Our facilities maintain compliance with FDA and EMA regulations, ensuring the highest standards of quality and safety. We also integrate advanced technologies like automated inventory management systems and AI-driven predictive analytics to enhance our operational efficiency.

All storage areas are engineered and operated in full compliance with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP), ensuring product quality and integrity throughout the storage lifecycle. Our validated Environmental Monitoring System (EMS) provides continuous, real-time monitoring of temperature and humidity across all critical storage zones. This system includes automated alarm notifications, guaranteeing immediate response to any deviation and maintaining the integrity of stored materials.

We adhere to global regulatory expectations by performing regular temperature and humidity mapping of all storage areas. These studies are meticulously conducted in accordance with the WHO Technical Report Series, No. 961, ensuring a consistently qualified storage environment. Mapping results are thoroughly analyzed to confirm temperature uniformity and to identify any potential hotspots or risk zones, which are then addressed through proactive preventive actions. The frequency of these mappings is every 3 years.

In line with our commitment to sustainability, our Taiwan facility employs energy-efficient storage solutions and waste reduction strategies, aligning with eco-friendly practices that appeal to socially responsible clients.

By integrating real-time monitoring, stringent environmental controls, and adherence to international compliance standards, we ensure that all stored materials—from raw materials to finished pharmaceutical products—are maintained under optimal and validated conditions. This robust storage capability is a critical component of our unwavering commitment to quality, product integrity, and patient safety. Our system provides tamper-proof data logging and real-time alerts, simplifying audit preparation and ensuring no critical data is missed.

Through expert staff training and strategic partnerships with leading research institutions, we remain at the forefront of industry innovation. Our flexible solutions and comprehensive risk management strategies further demonstrate our dedication to meeting the complex needs of our clients.

As we continue to optimize our biologics storage infrastructure, we invite you connect with Bora Biologics, and let us unlock the potential of your biologics projects together.

About the Author

Chris Kao is a dedicated Material Management & Logistics Senior Specialist at Bora Biologics, where he has been contributing his expertise since 2022. With a strong foundation in validation and quality assurance, Chris brings over 14 years of experience in the biopharmaceutical industry.

Prior to his role at Bora Biologics, Chris served as a Validation Senior Engineer at JHL Biotech/Eden Biologics, where he played a crucial role in ensuring compliance and quality throughout the validation process. His earlier experience includes positions as a QA/Validation Supervisor at Winston Medical Supply Co., Ltd., and as a Manufacturing Engineer at Adimmune Corporation, where he honed his skills in quality assurance and manufacturing operations.

At Bora Biologics, Chris focuses on optimizing supply chain processes and ensuring the integrity of material management. His commitment to excellence and meticulous attention to detail align seamlessly with Bora Biologics’ mission to deliver high-quality biopharmaceutical solutions. Chris holds a degree in Food Science, which complements his extensive professional experience and enhances his ability to drive efficiency and reliability within the organization.