Thawing of Pooled, Solvent/Detergent-Treated Plasma octaplasLG®: Validation Studies Using Different Thawing Devices

Abstract

Background: The aim of this study was to perform validation of the thawing process for solvent/detergent-treated plasma octaplasLG® using different thawing devices. Optimized settings for temperature and thawing time should be defined based on the results of both temperature measurements and extensive biochemical characterization studies. Methods: octaplasLG units were thawed using water bath systems (i.e. MB-13A, QuickThaw® DH4), dry tempering systems (i.e. plasmatherm, SAHARA-III), and microwave oven (i.e. transfusio-therm® 2000). Optimized thawing conditions were defined. Subsequently, using the selected thawing conditions, octaplasLG units were thawed and tested on product release parameters. Results: The fastest thawing was observed for the microwave oven. All octaplasLG units thawed by different devices and optimized thawing conditions were clear and free of solid and gelatinous particles, indicating no protein denaturation or overheating. In addition, no significant differences were found in the coagulation and inhibition activity and hemostatic potency of octaplasLG when thawed by the different devices tested. All parameters after thawing were within the product release specification levels. Conclusion: Our study demonstrated that octaplasLG can be thawed using all above listed devices without any negative influence on the plasma quality, presupposed that optimized settings defined for this plasma product are used.

Single‐donor spray‐dried plasma

“…The European Pharmacopeia specifies pH between 6.5 and 7.6 and osmolality >240 mOsm/kg for a plasma product . ODP was similar to LyoPlas in pH (7–7.2) and Octaplas in osmolality (360 mOsm/kg; specification: 320–420) …”

Automated dry thawing of cryopreserved haematopoietic cells is not adversely influenced by cryostorage time, patient age or gender

“…Recently, however, variants of equipment that enable water-free thawing of larger samples, held in cryobags, are becoming available. These systems use mechanical heating, such as a warm metallic plate as used in this study and/or warmed but sealed liquids that do not come into direct contact with the sample being thawed [11][12][13][14][15]. These systems eliminate user-to-user variability and provide a consistent, programmable process that removes any subjective intervention on the part of the user.…”

“…They also provide options for computerised control, monitoring and data recording. Previous studies have also indicated that dry thawing can be applied successfully to non-cellular therapeutic materials such as plasma samples [11][12][13]15], however as water is fluid and a very effective thermal conductor, these typically have slightly longer warming times than a water bath-based system.…”

Cryopreservation as a Key Element in the Successful Delivery of Cell-Based Therapies—A Review

“…The use of this type of equipment should eliminate the subjective assessment of thawing and provide a consistent procedure that requires no specific expertise on the part of the operator. In addition to cryobags ( 48 , 184 , 185 ), non-cellular therapeutic materials such as plasma samples can be thawed using this type of equipment ( 186 ).…”