Next Breath, a division of AptarGroup, announced the extension of its cGMP analytical services to include development services for injectable delivery systems, with a core focus on extractables and leachables (E&L)
Next Breath will be highlighting its new services at the upcoming drug delivery and packaging conference, Pharmapack, 7–8 February, 2018 in Paris, France.
For more than 16 years, Next Breath has offered a wide array of dedicated analytical services for inhalation and nasal drug development while providing support for global regulatory strategy.
This recent addition of services for injectable delivery comes as a natural extension for the company to support its growing portfolio of global customers looking for guidance to help them navigate through the increasing quality expectations for component qualification, validation and regulatory compliance.
As part of these services, Next Breath works with customers to define the characteristics of elastomeric components that are best suited for its drug product, assess functionality for the intended use, examine extractables and leachables, determine physical and chemical compatibility. This systematic approach makes Next Breath services ideal for identifying potential leachables and meeting regulatory expectations.
“Next Breath is excited to marry our analytical chemistry capabilities and delivery systems expertise to service the injectable market,” said Dr Julie Suman, RPh, President of Next Breath.
“We are in a unique position to support our clients’ requirements from an extractables profile to toxicological assessment in this evolving regulatory market.”
“E&L services provided by Next Breath offer an added-value to the Injectables Division, which will not only facilitate component selection but also accelerate regulatory approval,” said Bas van Buijtenen President of Injectables Division at Aptar Pharma.
To learn more about Next Breath services and how they can help support stability studies, regulatory approval and post-market approval for injectable delivery systems, visit the Aptar Pharma booth B24-B26 at Pharmapack.