With the emergence of cell and gene-based therapies, healthcare professionals are able to treat a wide range of disease indications, including chronic and rare diseases. Cell-based therapies involve replacing diseased or non-functional cells with functional cells to regulate the body’s normal functioning. According to the Roots Analysis, since 2019, more than 1,035 clinical studies that have been initiated have been emphasized on the cell therapy candidates. Given the ongoing advancements in technology and increasing trends toward personalized treatment approaches, it is no surprise that more cell therapies will be introduced in the upcoming years.
Despite its significant demand, pharmaceutical players are fraught with challenges in the delivery of cell therapies to a distance safely without losing their viability. These therapies have been developed using live cells that pose a short life cycle and lose their viability if not stored properly. Further, cell therapies may get damaged when they come into contact with the external environment. Thus, pharmaceutical companies have to optimize their packaging solutions and are required to maintain ultra-low temperatures to deliver therapeutic drugs without losing their quality. Packaging of cell and gene therapies is complex and requires adequate resources that can maintain low temperatures. Driven by the intricacies, several pharmaceutical companies have begun outsourcing packaging solutions from cell therapy packaging market players. In order to deliver cell therapies safely and in a timely manner, these market players need to consider the challenges associated with cell therapy transportation, which are listed below.
Key Considerations for Safe Delivery of Cell Therapies
Cell therapies can easily degrade when they come in contact with external environments or any reactive material in which they are stored. Considering the challenges, regulatory authorities such as the FDA have set stringent guidelines about the safe packaging of cell and gene therapies. Cell therapy market players have to choose an inert packaging system and meet the standard packaging requirement according to the regulatory authorities’ guidelines. Additionally, for safe delivery of cell therapies to the patients, it is essential to consider the areas listed below as an essential part of the packaging as well as the distribution process.
1. Packaging Systems
Cell therapy packaging systems such as primary, secondary, and tertiary packaging have to meet recent Good Manufacturing Practice and standard regulatory requirements. Moreover, the cell therapy packaging market players require maintaining closure integrity and product stability. The packaging material selected for the delivery of cell and gene therapies must be easily accessible, and standard regulations necessitated displaying information about end users, manufacturers, and clinicians. Some other key considerations that have to be considered for cell and gene therapy product delivery by packaging engineers are listed below:
▪ The packaging solutions ranging from operation to performance qualification must be able to hold mechanical and thermal stress that can potentially degrade the cell therapies.
▪ Stringent regulations should be compulsory, and separate regulations should be required for primary containers, secondary containers, internal pressurization tests, and leak-proof containers.
▪ Primary and secondary packages must be designed to maintain the durability and state of the cell therapies when they are rendered to cryogenic temperatures.
▪ Secondary and tertiary labels on the packaging containers should be aligned with abrasion and adhesion tests. The test is compulsory as it replicates the actual storage and shipping requirements. It helps to collect information about potential hazards and improve the packaging.
▪ Packaging containers must be able to prevent contamination of liquid and gasses such as CO2 and nitrogen.
2. Cold Chain Packaging
Each step of the cold supply chain must require unique parameters, such as low temperature to meet regulatory guidelines and patient safety regulations. Comprehensive data is required to determine temperature ranges and allowed deviations from the temperature for each unique product, including ablation kits and vectors for viruses. This data must be validated rigorously under simulated settings and resist the physical and thermal demands applied during handling and transportation. A two-shipper system may typically handle gene therapy items that must be stored at cryogenic temperatures to retain their effectiveness, using a dry ice carrier and dry nitrogen vapor shipper, but must be extensively reviewed to establish acceptability. Temperature control shipping systems must feature built-in temperature monitors and biosensors that help track temperature and information about mechanical stress. In addition, cell therapy packaging market players and service providers have to maintain end-to-end logistical records to ensure consistent delivery and performance within the cold supply chain.
3. Requirement of Hazardous Material Qualification
Several regulatory authorities, such as the FDA and the U.S. Department of Transportation, generate guidelines for shipping cell therapies to avoid penalties. Cell and gene therapies are hazardous and degrade when comes in contact with the environment and other reactive materials. Hence, it is imperative for cell therapy packaging market players to develop comprehensive packaging and proper labeling documents that ensure shipping containers are safe for transportation.
Inadequate prepping and development of package design may jeopardize certification testing or clinical and commercialization launches. Noncompliance with standards and lack of qualification may result in harsh fines. Hazardous material leaks can result in an FDA audit, which, if not completed, can result in fines and other consequences. As a result, adequate training for individuals in the supply chain is critical to compliance.
4. Traceability
It is vital to maintain the chain of identity and supervision throughout the drug supply chain, as autologous cell therapies are tailored according to the patient’s individual requirements. This chain of identity enables easy tracking of patient cell therapy products—a chain of custody ensures seamless tracking throughout the therapy supply chain.
The chain of identity generation procedure should be recorded and clearly mentioned in the recording of the batch. It should also contain apheresis collection data till the patient receives the product. Traceability technologies have made it simpler to transport and track cell and gene therapy products; however, since use cases are still in their early stages, careful setup, assessment, and implementation are necessary.
Concluding Remarks
Overall, the cell therapy packaging process is a time-consuming endeavor—the process requires meeting stringent regulations to ensure these therapies are safe and viable when delivered to the patients. However, in order to maintain a consistent supply chain, it is essential to overcome packaging hurdles and consider the above key considerations. Given the necessity of specialized equipment, several cell therapy packaging market players enter into collaborations to enhance their services and develop innovative packaging solutions. In the future, as the demand for cell therapies increases, there will be a surge in the requirement for advanced cell therapy packaging solutions, which is anticipated to drive the market in the future.
About Roots Analysis
Roots Analysis is a global leader in the pharma / biotech market research. Having worked with over 750 clients worldwide, including Fortune 500 companies, start-ups, academia, venture capitalists, and strategic investors for more than a decade, we offer a highly analytical / data-driven perspective to a network of over 450,000 senior industry stakeholders looking for credible market insights. All reports provided by us are structured in a way that enables the reader to develop a thorough perspective on the given subject. Apart from writing reports on identified areas, we provide bespoke research / consulting services dedicated to serving our clients in the best possible way.
