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Safely getting life-altering cell, gene and mRNA therapies to the market is critical for patients. Choosing the right specialized packaging can help. Daikyo Crystal Zenith® containment solutions have a demonstrated track record with advanced therapy medicinal products (ATMPs).
The use of live human cells to treat or prevent disease and/or repair or replace damaged tissue or cells
The use of genetic material to treat or prevent disease by fixing or replacing mutated genes
The use of messenger RNA to prepare the body to fight bacteria, viruses or pathogens
Many advanced therapies are receiving breakthrough designation status, which shortens development timelines. However, resource constraints within small-to-midsized pharmaceutical companies combined with multiple containment options to assess can make it challenging to get to market quickly.
Because cell and gene therapies are a new and emerging field, the still-developing regulatory guidelines are unclear to companies working on these drugs. Agencies continue to issue guidance and staying ahead of anticipated changes is a challenge.
Identifying packaging materials that meet the high demands of advanced therapies is challenging. The packaging must ensure drug sterility, container closure integrity at ultra-low and cryogenic temperatures, break resistance, and facilitate high yield and drug recovery.
Cell and gene therapies are highly sensitive to temperature. They require ultra-low and cryogenic temperatures to maintain the integrity of the drug during storage and transport. The physical property of materials changes at extremely low temperatures, leading to loss of CCI or cracking upon thawing. It is critical to use packaging components maintain CCI across multiple freeze and thaw cycles down to cryogenic temperatures.
Particulates, leachables and extractables can compromise the safety and efficacy of cell and gene therapies. Packaging systems should be inert, not introduce particulate quality issues and meet the tightest industry material specifications and regulatory requirements. In addition, the packaging system chosen should be available in multiple sizes to support scaling.
Cell and gene therapies are high-value precious drugs that often treat diseases that are rare, have very high unmet needs, or have limited treatment options. Each dose is upwards of hundreds of dollars. It is essential to use containment systems that are break resistant during the storage and transport at ultra-low temperatures and can deliver therapies without loss to the clinic for administration to the patient.
A significant challenge in package selection is selecting a container compatible with the therapeutic. Cell and gene therapies are more likely to interact with surfaces than other types of molecules. It is very important to consider container material that will reduce product loss. The container should be inert, retain the functionality, recovery and protect the drug.
West has vast expertise and experience in extractables and leachables, particle analysis, container closure integrity, and performance and packaging/delivery systems. As a result of our understanding of materials and delivery systems and their compatibility with the drug product, we can assist our customers in designing studies and navigating the challenging and evolving regulatory landscape.
To support the growing demand for complex cell and gene therapy products, West provides advanced containment solutions for efficient fill-finish processes. Our packaging solutions including vial-stopper-seal system, or vials packed in tray format or in nest tub configuration is scalable for all manufacturing quantities, compatible with various filling systems, and allows for flexible purchasing options.
Featuring Crystal Zenith® Vials, Used in Majority of Approved Gene Therapies in the Market
Featuring Crystal Zenith® Vials, Used in Majority of Approved Gene Therapies in the Market
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