Over the years, the pharmaceutical industry has witnessed several advancements in drug development. It has gradually shifted from a one-drug treats all model to a more personalized approach of treatment, which involves the use of personalized cell therapies for various disease indications. This shift has led to an evident change in the pharmaceutical packaging domain as well. The cell therapy packaging is relatively complex than that of small molecule therapeutics and other biologics. It requires specific conditions for fill / finish, storage and transportation in order to maintain sterility and viability of cells at cryogenic temperatures and stringent quality standards. Considering the packaging, storage and drug administration-related demands of the modern healthcare industry, experts believe that a modular approach to packaging methods would be beneficial, both in terms of time and cost.
Types of Pharmaceutical Packaging
There are three types of packaging, namely primary packaging, secondary packaging and tertiary packaging.
Additional details, highlighting the key purpose of various types of packaging are outlined below:
Primary packaging: It refers to the material that is in direct contact with the drug product and therefore, has a direct impact on its shelf life. Examples include vials, ampoules, syringes and intravenous (IV) containers.
Secondary packaging: It is the covering around the primary packaging used to collectively contain groups / sets of primary packages. Examples include cartons, boxes and trays.
Tertiary packaging: It refers to the type of packaging used when the product needs to be handled in bulk or shipped. Examples include barrels, containers and edge protectors.
Primary Packaging of Cell Therapies
Primary packaging, specifically glass and plastic container systems, plays a pivotal role in the protection of the therapy product contained within, from a number of environmental factors. Additionally, it is responsible for maintaining the stability of the product throughout its entire lifecycle. The container must be compatible with the manufacturing process of cell therapies. The below figure represents the three most common product containers specifically used for cell therapies.
Secondary Packaging of Cell Therapies
Secondary packaging is used to protect the primary packaging and keep the label intact under critical environmental conditions. This type of packaging uses cartons and metal cassettes to cover cryopreserved vials and bags containing cell therapy products. Secondary packages are designed to fit into specific racking systems used in cell therapy liquid nitrogen (LN2) shipping containers. These LN2 packages have different neck diameters and payload volumes that vary according to suppliers. In addition, dry vapor shippers, Styrofoam boxes (specially designed for cell therapies), coolers are also used as secondary packaging solutions.
Considerations for Cell Therapy Packaging
Process of packaging cell therapies is different from that of other biologics and small molecule therapeutics owing to the differences in their production, storage, shipping and end use. Some of the key factors to be considered during cell therapy packaging include:
Extreme temperature fluctuations: During the process of manufacturing, storage, shipping and end use, cell therapy products are exposed to varied temperature conditions, ranging from -196°C to 37°C. Hence, the manufacturer is required to check product stability across all temperatures. Given the cryogenic nature of the drug product, packaging procedure is advised to be executed under cryogenic conditions in a LN2 temperature-controlled cart, called CryoCart.
High Cost: Cell therapy products are expensive, therefore require firm packaging and distribution system, that can protect the integrity as well as represent the high value of pharmaceutical product.
Labeling conditions: Labeling of cell therapies require patient-specific details along with the chain of custody labeling, unique NDC codes for various dosing kits, and additional labeling text statements, impacting the impact label size and placement. In certain cases, information has to be presented in multiple languages on the product label.
Challenges in Cell Therapy Packaging
Cell therapy packaging companies face several challenges during packaging operations.
Given the complexities associated with handling of cell therapies, it has become imperative for cell therapy developers to outline a strategic plan for their packaging and transportation. Moreover, it is important to re-evaluate the packaging considerations for these personalized treatment options. Packaging should ensure the sterility and quality of cell therapies, while providing information on identity and, in certain cases, dosing instructions as well. Primary packaging, owing to the fact that it is in direct contact with the therapy, is considered to be critical for preservation of product stability, efficacy and safety.
Further, in order to optimize drug-packaging compatibility, stakeholders in the pharmaceutical packaging industry have adopted a number of other flexible solutions to reduce overall cost and expedite time to market. In addition, several cell therapy developers have forged strategic agreements with stakeholders offering primary and secondary packaging services or products to ensure the integrity of the therapeutic intervention while storage / transport. The latter companies are steadily advancing their packaging technologies beyond the conventional packaging products to meet the demand for cold chain and cryogenic environment required to maintain the stability of these novel, state-of-the-art therapies.
For more details on this emerging domain, check out the following report: