ALTDORF, Switzerland—Set against the background of an increasing demand for highly sensitive drugs such as biologics and biosimilars, the requirements for parenteral packaging and elastomer components in the contemporary health care industry are changing rapidly.
Market trends indicate a growing demand for fluoropolymer-coated elastomeric closures, primarily to mitigate risks related to drug stability and compatibility.
The efficacy of therapeutic proteins that are integral to biosimilars and biologics, depends on their exact chemical make-up and three-dimensional conformation. Interactions with added processing agents, such as silicone oils, can lead to the ineffectiveness or the immunogenicity of drugs, causing chemical or conformational changes and degradation or aggregation of the highly sensitive proteins.
As a result, pharmaceutical and medical manufacturers are increasingly choosing packaging solutions that provide low particle levels and an excellent particle management.
To meet the requirements of biologics packaging, barrier properties are no longer sufficient.