Plastic Packaging for Parenteral Drug Delivery

Minimizing Oxidation of Freeze-Dried Monoclonal Antibodies in Polymeric Vials Using a Smart Packaging Approach

“…Freeze-drying is a frequently employed technique to provide sufficient shelf life and improved stability during shipping for labile protein drugs [ 5 , 6 ]. Vials made of glass are the most common primary packaging for freeze-dried pharmaceuticals [ 7 ] due to the materials’ inertness, transparency and excellent barrier properties against moisture and gases [ 8 , 9 ]. Nevertheless, concerns with glass like ion leaching, delamination and its susceptibility regarding breakage can affect safety and efficacy [ 7 , 10 ] and thus may lead to recalls [ 11 ].…”

“…Nevertheless, concerns with glass like ion leaching, delamination and its susceptibility regarding breakage can affect safety and efficacy [ 7 , 10 ] and thus may lead to recalls [ 11 ]. More recently, vials made of cyclic olefin polymers and copolymers (COP and COC) have attracted attention as they have overcome the major drawbacks of glass by showing excellent chemical resistance [ 9 ] and low adsorption [ 7 , 12 , 13 ], while likewise providing a translucent and inert surface [ 7 ]. Moreover, an obvious benefit over glass is the great break resistance of the polymers, which therefore makes them favorable for recent cell and gene therapies as well [ 10 , 14 , 15 , 16 ].…”

“…Moreover, an environmental benefit using polymer over glass vials was found [ 17 ]. For more detailed information on plastic packaging, the reader is referred elsewhere [ 9 ].…”

“…It has been shown previously that lyophilization in cyclic olefins results in homogeneous heat transfer [ 18 ] and increased uniformity within the cakes [ 9 ]. The major disadvantage of these polymeric materials is their permeability to gases, e.g., oxygen and water vapor [ 10 ], and therefore shelf life might be jeopardized.…”

“…Particularly when it comes to biopharmaceuticals, which are prone to oxidation, contact with oxygen needs to be eliminated during storage. Since oxygen is constantly available in the ambient air, it can either damage biopharmaceuticals by directly oxidizing susceptible amino acids (e.g., methionine, cysteine) or by generating reactive oxygen species (ROS) [ 9 ]. Protein oxidation is one of the major degradation pathways and can lead to detrimental biological consequences, i.e., loss of potency, altered pharmacokinetics as well as unwanted immunogenicity [ 19 , 20 , 21 ].…”