Using Prefillable Syringes for Biopharmaceuticals – Development & Challenges

The progress of genetic engineering has spurred a shift in pharmaceutical development from low-molecular drugs towards biopharmaceuticals. Looking at the top ten drug sales ranking in the world, biotherapeutics, such as Humira (adalimumab), Remicade (infliximab) and Rituxan (rituximab), have progressed substantially, in contrast to lowmolecular blockbusters like Lipitor (atorvastatin calcium) or Plavix (clopidogrel), which mainly constitute the market in the last decade.1 At the same time, the patent cliff of several biotherapeutics and thus the loss of exclusivity (LOE) is propelling the development of biosimilars and biobetters. Many biotech drug products are lyophilised in vials due to their poor stability for parenteral administration. However, the development of liquid formulations of biotech products applying prefilled syringes has been increasing rapidly, driven also by enhanced safety in use, user convenience and ease of administration. Another important aspect is the shift from hospital treatment to homecare and patient selfinjection for many chronic diseases and specific therapeutic areas. This article addresses a technology approach to developing a prefillable syringe system as an appropriate parenteral drug container for biopharmaceuticals.