Small Volume ATMP Cryo-Freezing Strategies

Discover best practices for small-volume cryopreservation of Advanced Therapy Medicinal Products (ATMPs), addressing critical challenges in the field. These challenges include leakage, contamination, and reduced cell viability, which are particularly crucial given the ultra-low temperature storage requirements (-130°C to -190°C) for ATMPs.

Maintaining sterility is paramount in ATMP cryopreservation. The paper emphasizes the importance of ensuring the integrity of single-use bioprocess containers and aseptic connectors to minimize contamination risks and product loss. Innovative solutions, such as CPC's MicroCNX® aseptic connectors and Single Use Support's RoSS.KSET protective freezing system, are highlighted as effective tools for enhancing the cryopreservation process.

The MicroCNX® connectors provide sterile, tamper-evident connections, effectively eliminating contamination risks in fluid handling. The RoSS.KSET system offers protection for single-use bags and tubing assemblies, significantly reducing the risk of breakage and ensuring product integrity throughout the freezing, transport, and storage phases.

Controlled-rate freezing is identified as essential for preserving cell viability. The paper recommends freezing rates between -1°C/min and -4°C/min. The use of cryoprotectants, such as DMSO, is discussed as a means to mitigate freezing damage, with the caveat that these must be compatible with storage materials.

The white paper also highlights the efficiency gains of using aseptic connectors over traditional tube welding. This innovation reduces connection time from minutes to seconds, thereby increasing productivity and reducing operator workload.