Packaging Considerations for Biopreservation

Abstract

The packaging system chosen for biopreservation is critical for many reasons. An ideal biopreservation container system must provide for closure integrity, sample stability and ready access to the preserved material. This means the system needs to be hermetically sealed to ensure integrity of the specimen is maintained throughout processing, storage and distribution; the system must remain stable over long periods of time as many biobanked samples may be stored indefinitely; and functionally closed access systems must be used to avoid contamination upon sample withdraw. This study reviews the suitability of a new commercially available vial configuration container utilizing blood bag style closure and access systems that can be hermetically sealed and remain stable through cryopreservation and biobanking procedures. This vial based systems allow for current good manufacturing/tissue practice (cGTP) requirements during processing of samples and may provide the benefit of ease of delivery by a care giver. In this study, the CellSeal^® closed system cryovial was evaluated and compared to standard screw cap vials. The CellSeal system was evaluated for durability, closure integrity through transportation and maintenance of functional viability of a cryopreserved mesenchymal stem cell model. The results of this initial proof-of-concept study indicated that the CellSeal vials are highly suitable for biopreservation and biobanking, and provide a suitable container system for clinical and commercial cell therapy products frozen in small volumes.

Comparison of cryopreservation bags for hematopoietic progenitor cells using a WBC-enriched product

“…The integrity of these bags is very important to ensure sterility and viability of cryopreserved cells [4,10]. The MBand MP-bags remained intact after five freezing and thawing cycles, even after a drop test with frozen material, whereas of the reference bag (B-bag) two bags ruptured.…”

“…Dimethyl sulfoxide (DMSO) is typically used as a cryoprotective agent [1][2][3]. HPCs are stored in special cryopreservation bags that fulfill the following requirements: are resistant to DMSO, provide enclosure integrity, are a functionally closed access system, provide sample stability over a long period of time and are resistant to low temperatures [4]. HPC material is stored in liquid nitrogen (−197°C), vapor phase of liquid nitrogen (−150°C) or in a mechanical freezer at −135°C or −80°C [5].…”

Technical Considerations in the Freezing, Low-Temperature Storage and Thawing of Stem Cells for Cellular Therapies

“…CellSeal® closed-system cryogenic vials (www.cookregentec.com) provide a ported system which can be sealed using a standard RF sealer [27] and for which a semi-automated filling system has been developed. A heat-sealable cryotube has also been developed by CryoBioSystems (www.cryobiosystem.com) with the same isomeric resin used for their vitrification straws.…”

Physico-chemical ageing of ethylene–norbornene copolymers: a review

“…They exhibit very useful physico-chemical properties such as glass-like transparency, rigidity, heat and chemical resistance and low permeability to gas and water [1][2][3][4][5][6][7]. These features make cyclic olefin copolymers (COC) of interest for many applications.…”