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Prefilled syringes and the biologic challenge

Prefilled syringes and the biologic challenge

Biologic manufacturers face increasing pressure to find improved packaging solutions for both clinical trials and commercial supply. These pressures are driven both by the growing biologic market (expected to reach $250 billion in 2024*) and other factors such as the development of increasingly complex compounds, a greater need for flexibility in development, and the growth of self-administration in the home care segment.

The complexity of biologics packaging

Biologic compounds such as monoclonal antibodies are inherently complex and require special consideration during formulation for a prefilled syringe format. Compatibility, for example, is often a particular hurdle because of the number of additional components in a prefilled system (the closure system, for example) and the need to maintain the functionality as well as the shelf life of the end product. Tungsten, silicone oil, and even adhesives (used to secure the needle in the glass barrel) can potentially leech into these sensitive drug products and result in unexpected impurities.

Choosing the optimal drug delivery system

The sensitive nature of biologics isn’t the only factor to take into account when choosing a drug delivery system. Drug manufacturers also need to ask a number of questions regarding both the market and the manufacturing aspects of their biologic product, such as:

  • Is the product liquid or lyophilized?
  • What are the therapy requirements?
  • Is this a self-administered therapy?
  • What is the duration of therapy?
  • What do the product life cycle, cost, and competition look like?