With the increasing demands for highly sensitive drugs such as biologics and biosimilars, the requirements , pharmaceuticals and medical product manufacturers are need elastomer components that not only mitigate risks related to drug stability and compatibility, but also provide low particle levels. Here, Datwyler reports on how it is adapting its capabilities and offerings to meet these new industry requirements:
Datwyler: Elastomers for tomorrow’s healthcare market
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.
Meeting the challenging needs of drug packaging has become an important concern not only for medical and pharmaceutical manufacturers, but also for suppliers.
Omni-Flex coated products are exclusively produced in the state-of-the-art facilities. Introducing the First Line manufacturing standard to the global and local markets, Datwyler is currently building two additional First Line aligned facilities in the US and in India.
The company’s latest strategy for the healthcare segment also features three standardised 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.