Putting the freeze on biologics

As more biologics and biosimilars come onto the market, they offer new treatment options for many cancers and autoimmune diseases, such as rheumatoid arthritis, multiple sclerosis, Crohn’s disease and psoriasis

However, these cutting-edge therapies are often moisture- and temperature-sensitive, presenting new packaging and containment challenges.

To ensure optimised storage and moisture protection for their injectable drug products, biopharmaceutical companies are increasingly turning to the process of lyophilisation for biologics and other drugs that are sensitive in liquid form or sensitive to their environment.

Lyophilisation is considered to be an ideal process for injectable drug products that may have a limited shelf-life in solution. Some drug formulations are unstable in aqueous solutions; the active ingredient can interact with, and degrade quickly in, water.

Such moisture-sensitive drugs are often lyophilised to not only protect them from external elements, but also to protect them from their own eventual decay.1

But there are drawbacks: maintaining a lyophilised drug product’s stability during its shelf-life can be difficult for moisture-sensitive pharmaceuticals. Moisture can reach a lyophilised drug product in a variety of ways, the simplest being a lack of container closure integrity (CCI) in the stopper-vial combination.

Additionally, residual moisture from steam sterilisation of the closures prior to lyophilisation could be released from a rubber stopper into the vial headspace, permeating into the drug with time. Other common issues with the lyophilisation process include drug product loss owing to stoppers sticking to the shelves, loss of vacuum within the vial and process-generated glass breakage.

Forward-thinking biopharmaceutical companies are addressing these challenges in a variety of ways. Foremost among these is proactively working with drug packaging manufacturing partners to understand the unique needs of their drug product and how its containment system can protect the drug’s quality and integrity. This can include a number of data-driven decisions, such as evaluating seal integrity and identifying potential CCI or moisture risk issues that can impact the pharmaceutical product.

With this careful planning and consideration, pharmaceutical companies can leverage solutions that are currently available in the marketplace to address the challenges commonly associated with processing and storing sensitive drug products. For example, by selecting components that are manufactured using clean, high-quality elastomer formulations and that are washed and sterilised — meaning they arrive ready-to-use on a filling line and avoid the need for additional steam sterilisation that can lead to unwanted moisture.

Additionally, there are now seals available that are constructed of medical-grade polypropylene, which, unlike their metal predecessors, minimise the risks associated with established lyophilisation processes while maintaining the necessary sealing requirements.

Lyophilisation is quickly becoming a popular option for many new biologic and biosimilar therapies, but even the most innovative therapeutic offering will not live up to its market potential without careful consideration of how the drug is contained and, ultimately, delivered to the patient. By taking a proactive, collaborative approach, companies can ensure that they are selecting the most appropriate packaging components and mitigating some of the most complex risks associated with cutting-edge, sensitive drug products.

Reference

  1. www.pharmpro.com/articles/2012/06/new-scope-pharmaceutical-lyophilization.

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