Biostór’s cold-chain logistics is at the forefront of temperature-controlled shipping, specializing in cryopreserved shipments of cold-chain vaccines and tissue products throughout Europe. We prioritize secure, compliant, and efficient transportation to safeguard the integrity of your valuable biological assets. 

As medical treatments advance, incorporating human cells and genetically manipulated cells, the potential for restoring lost bodily functions becomes astonishingly real. Developments in Cell & Gene Therapy (CGT) have been swift, driving the demand for a logistics infrastructure that can match extraordinary user requirements. Our Cold-Chain Logistics ensure meticulous timing, absolute compliance, and dedicated personnel performance to accommodate the intricacies of CGT shipments. 

In the EU, regulations are comprehensive and rigorous. Directive 2004/23/EC covers the donation, procurement, and testing of Tissues and Cells, while further manufacturing steps fall under Directive 2001/83/EC relating to medicinal products for human use. Cold chain vaccines, processing, preservation, storage, and distribution adhere to specific Community legislation like The ATMP Regulation. 

LN2 DRY SHIPPERS

Temperature control is vital for preserving product quality, sample integrity, and patient safety. We provide advanced monitoring solutions, from data loggers to sophisticated temperature and location tracking systems. Biostór employs GPS tracking and real-time data visibility, ensuring compliance and peace of mind for road-based cryopreserved shipments throughout Europe. 

Biostór continually invests in state-of-the-art transport solutions to meet the evolving needs of the industry. While our LN2 Dry Shippers have been a reliable choice, operating at -190°C within a 10–14-day window for transporting cryopreserved human Bone Marrow, Cord Blood, Clinical Trial samples and Master Cell Banks worldwide, we understand that the landscape is changing.  

The emergence of real-time autologous therapies, involving the transportation of cooled live cells, presents us with new logistical challenges and compliance complexities. At Biostór, we’re at the forefront of addressing these challenges.  

We recognize that the quality of transport conditions is paramount, as it significantly influences the quality of Cell and Gene Therapy (CGT) products and samples. To ensure the highest standards, Biostór follows a meticulous approach:  

• Defined in Writing: Our transport conditions are clearly defined in documented procedures.  
• Qualified: We rigorously qualify and regularly validate our transport systems to guarantee their reliability and performance.  
• Representative of the Batch: Transport conditions are designed to be representative of the specific CGT product batch being transported.  
• Checked Before Certification: Prior to certifying any CGT batch for transport, we conduct thorough checks to verify that transport conditions align with our stringent standards.  
• Compliant with MA Terms: Our transport conditions are consistently compliant with the terms set forth in the Marketing Authorisation (MA), ensuring that every transport meets regulatory requirements.  

At Biostór, we are committed to maintaining the highest standards in the transport of Cell and Gene Therapy and Advanced Therapy Medicinal Products (ATMP). Our goal is to provide you with complete confidence in the integrity and quality of your valuable materials during transit.