Many current cell-based products are produced, frozen, stored, and delivered to the clinical site in intravenous (IV) bags or polypropylene screw-cap containers. Although IV bags are sufficient for small-scale processes, they may not be suitable for commercial scale. Bag failures can lead to microbial contamination of the cell product, increased product preparation time, increased antibiotic use, and increased resource expenditure to replace products.
Plastic resins (such as polypropylene) have been used in R&D or early preclinical/clinical activities. The regulatory environment for container–closure integrity, extractables, and scalability can be challenging for screw-cap containers. As the industry expands and moves to commercialize cell-based therapies, there is a clear need for a scalable, vial-based packaging system for pharmaceutical fill finish operations.
A system incorporating a sterile Daikyo Crystal Zenith® vial and a stopper adapted for cryogenic use offers an ideal solution for low-temperature or cryogenic storage and transport of high-value biological drugs.
Crystal Zenith cyclic olefin polymer is nonpolar, which prevents water and liquid drug preparations from adhering to the vial surface, so it has low moisture absorption and excellent drainability. It is compatible with a wide pH range (2–12) and solvents such as alcohols, ketones, and cellosolves. The Crystal Zenith polymer also has excellent thermal characteristics and can withstand cryogenic temperatures (–185 °C) as well as sterilization by autoclaving (121 °C) (1). Compared with polypropylene, it also has lower gas and moisture permeability.
The Crystal Zenith vial in combination with a stopper adapted for cryogenic applications offers
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Superior barrier properties compared with other plastics; break-resistance; low extractables/leachables
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Proven use for storage and transport of cell lines at cold and cryogenic temperatures
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Ability to visually inspect; ease of automation and scalability to commercial volume.
Daikyo Crystal Zenith vials are used in therapeutic areas including osteoporosis, oncology, antifungal, and radiology. The vials have been proven in the market and have met or exceeded the quality requirements of regulatory agencies. Appropriate Drug Master Files and technical dossier are filed or available per regional requirements.
Ease of Filling Line TransitionA standard filling line can be adapted for Crystal Zenith vials (sterile or nonsterile) and tailored to filling cell-based applications. Many pharmaceutical companies are currently using Crystal Zenith vials in their glass filling lines. With minor changes to protect against scratching and slower rail speeds, filling of Crystal Zenith vials has been accomplished successfully. Currently, many companies have filed or will shortly file Crystal Zenith products with the United States, European, and Japanese regulatory authorities.
For more information, contact West’s Technical Customer Support:
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North America 1-800-231-3000
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Europe 49-2403-7960
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Asia Pacific 65-6860-5879