The Myonex Solution
To address Brenus Pharma’s needs ahead of its first clinical trial, at the time, Creapharm – since acquired by and now operating as Myonex – delivered an integrated solution encompassing highly secured ultra-cold storage, regulatory-compliant handling, and tailored logistics for temperature-sensitive biological materials.
The strategy built with Brenus Pharma included securing long-term storage for Master and working Cell Banks (MCBs and WCBs) in vapor-phase liquid nitrogen tanks at temperatures below -150°C, while ensuring full GMP compliance. The use of vapor-phase liquid technology eliminated the risk of cross-contamination, a potential concern with liquid-phase storage.
For preclinical samples storage, Myonex recommended -80°C mechanical storage as the best option for optimal stability and cost-efficiency. Considering the expected level of temperature consistency, Myonex and Brenus Pharma excluded -80°C LN2 Vario, as a premium technology, that would not have brought additional benefits here.
Product risk management and flawless traceability were at the core of the collaboration. Myonex offered rigorous safeguards to protect product integrity, with a risk-based approach, clearly defined workflows, specific competencies, and redundant temperature monitoring systems. Temperature was continuously monitored from receipt through to shipment, using redundant sensors and 24/7 alert systems. All data were securely recorded on a health data–certified server, and Brenus Pharma was provided with secure web access to their full product inventory and storage information.
The storage facility’s sectorized design in 3 distinct zones – GMP, R&D and Cell Therapy Preparations – allowed Brenus Pharma to benefit from physical segregation for their different product categories and thus, ensure regulatory compliance. Beyond GMP and non-GMP distinct storage, animal and human samples were also split into different LN2 tanks and freezers. At the operational level, the reception process was handled with great precision: dual personnel controls followed by a verification through the digital traceability system. Customized procedures allowed for relabeling and inventory reorganization of preclinical samples.
Logistics was also a key part of the solution. Myonex organized upstream and downstream flows, coordinating the pick-up of materials from multiple sites and managing their delivery to analysis laboratories and manufacturing partners when needed. To guarantee the cold chain throughout transport, Myonex leveraged its IATA and ADR-trained experts when orchestrating the network of qualified carriers and using dry shippers (nitrogen-based solutions). All shipments were monitored in real time, with temperature tracking and optional GPS, while documentation was co-developed with Brenus Pharma to ensure readiness and compliance.