4 Ways Freezing Bags Are Easier to Use Than Bottles

An efficient, next-generation facility relies on streamlined production strategies, but implementing new technologies might be perceived as a barrier to change. In this blog post, we discuss how a single modification in your freeze and thaw strategy can make facility operations run more smoothly.

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Drug developers are under constant pressure to reduce timelines and improve productivity. These goals must be met without compromising process reproducibility or product quality.

However, taking the leap to modify an existing process or employ unfamiliar, state-of-the-art tools can raise significant concerns. You want to guarantee that any changes made have a beneficial effect on your facility. Are the new tools scalable? Are they cost-effective? Will they save time? And – importantly – do they improve the day-to-day running of the facility? To limit the risks associated with any change, intelligent solutions that drive simplicity and quality while fitting into existing facility set-ups are desirable.

Freezing & Thawing Processes – An Opportunity for Change?

Freeze and thaw processes are becoming increasingly important in the biopharmaceutical landscape as new modalities emerge, production strategies evolve, and transport networks diversify.

Traditionally, drug substances are frozen in bottles or other rigid containers. They offer limited control, are not fully scalable, and require significant operator involvement, all of which contribute to increased risk. Additionally, conventional freezing containers are bulky, which cause storage and transport hurdles. However, it can be tricky to break away from such well-established solutions and place trust in emerging technologies.

Freezing bags are becoming more commonplace as the industry moves towards single-use solutions. Aside from their superior scalability, cost-effectiveness, and control capabilities, freezing bags offer various everyday advantages. Below, we reveal why switching from bottles to bags might be worthwhile from an operator's perspective.

1. Ergonomics

Freezing bags are "plug and play" systems, delivered sterile, assembled, and ready-to-use for your freeze and thaw applications. The container and pre-installed tubing configurations are easily handled by an operator without the need for additional tools, equipment, or validation. This convenient handling streamlines downstream process steps and saves valuable resources.

2. Stackability

Flexible freezing bags are typically housed in a sturdier outer container. This bag-in-shell design not only protects the precious and expensive drug substance but also makes the bags stackable. This feature allows users to maximize storage and shipping density, limiting facility footprint and simplifying transport logistics.

3. Flexibility

Single-use bag designs are compatible with any conventional or blast freezer, meaning they can be adapted to existing equipment and infrastructures without large capital expenditure (CAPEX). This flexibility is ideal when companies are hesitant to make changes due to the associated costs.

Additionally, freezing bags are typically highly configurable, meaning they can meet a variety of process needs and can be easily integrated into diverse set-ups. This flexible implementation improves operational efficiency.

4. Error Reduction

The ease of use offered by freeze and thaw bags reduces operator involvement, limiting the risks associated with handling errors. The sterile, closed systems (with qualified container integrity) protect the product, promoting safe and reliable processing. In addition to securing the integrity of the drug product, the ready-to-use system also reduces the workload for operators. There are fewer standard operating procedures (SOPs) to establish and follow, limiting paperwork and audit preparation.

Freezing Bags - Benefits at Every Level

The value of single-use bags for drug product integrity and cold-chain logistics has been well documented. Nonetheless, adopting new technologies or modifying a bioprocess requires careful consideration at all levels, including how the changes will affect the day-to-day running of your facility.

Single-use solutions can take significant pressure off operators and streamline how a facility functions. The switch from bottles to bags could be executed during the development of a new process, which avoids perceived disruptions to an existing process. However, the ease of implementation, the significant risk reduction associated with their use, and the immediate operational benefits mean these freeze and thaw solutions can be employed to optimize an existing process.

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