Fluoroelastomer Specialists
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.
As interactions of proteins with silicone oil can endanger the safety and efficacy of therapeutic proteins, the reduction and elimination of silicone oil and silicone oil-based subvisible particles (SbVPs) has become a legitimate concern for pharmaceutical and medical manufacturers.
Datwyler’s Omni Flex CP (coated plunger) was the first coated syringe plunger to provide barrier properties, and eliminate the plunger as a source of silicone oil—therefore contributing to the reduction of SbVPs.
Manufacturing standard
Meeting the challenging needs of drug packaging has become an important concern not only for medical and pharmaceutical manufacturers, but also for suppliers. Given this consideration, Datwyler’s facilities that are aligned to the “First Line” standards are designed to operate in a fully integrated good manufacturing practice (GMP) cleanroom environment. This approach serves to minimize endotoxin, bioburden, particulate and defect levels.
Omni-Flex coated products are exclusively produced in the state-of-the-art facilities. As it introduces the First Line manufacturing standard to the global and local markets, Datwyler is building two additional First Line aligned facilities in the U.S. and in India.
The company’s latest strategy for the health care segment also features three standardized offering categories to provide more transparency for clients: Bio Care for the most sensitive, large molecule drugs; Pharma Care for small molecule drugs which require production flexibility and optimum quality; and Med Care with a broad range of materials and technical support for medical companies.
Read more: Datwyler develops elastomers for tomorrow’s health care market
