Feature Article: Parenteral Packaging Concerns For Biotech Drugs: Compatibility Is Key

By Frances L. DeGrazio

Biotechnology promises treatments and even cures for many diseases previously considered intractable. Although the biotech industry began just about a quarter-century ago, since the late 1990s the number of new biopharmaceutical approvals has nearly equaled those for new small-molecule drugs.

Despite significant effort and research in delivering peptides and proteins through means such as inhalation, transdermal injection, and direct contact with mucous membranes, parenteral injection remains the principal delivery system for today's biotherapeutics. The packaging unit is typically a single- dose vial, with prefilled syringes less The drug is provided either as a solution or more commonly a lyophilized cake that a caregiver reconstitutes and injects using a syringe. Requirements for product purity, activity, and shelf life dictate a very high standard for injectible drug packaging, particularly for highly active peptides and proteins. But with biopharmaceutical development times averaging 7–10 years and costs measured in the hundreds of millions of dollars, it is too easy for innovator companies to dismiss primary packaging as an afterthought.