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Next Breath Announces Injectable Extractable and Leachable Services

//Next Breath Announces Injectable Extractable and Leachable Services

Next Breath Announces Injectable Extractable and Leachable Services

Baltimore, Maryland – January 19, 2018.

Next Breath, a division of AptarGroup, Inc., is pleased to announce the extension of their 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 their new services at the upcoming drug delivery and packaging conference, Pharmapack, held on February 7-8, 2018 in Paris, France.

For over 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 their 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 their drug product, assess functionality for the intended use, examine extractables and leachables, and 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 Julie Suman, R.Ph., Ph.D., 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, Injectables Division, 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.

About Next Breath 

Next Breath, a division of AptarGroup, is a full-service cGMP compliant laboratory specializing in analytical testing of a range of drug delivery systems from early stage to commercialization. Next Breath provides comprehensive solutions for the product development process from formulation and CMC support, to finished batch release and post approval stability to regulatory agencies worldwide.

About AptarGroup 

AptarGroup, Inc. is a leading global supplier of a broad range of innovative dispensing and sealing solutions for the beauty, personal care, home care, prescription drug, consumer health care, injectables, food and beverage markets. AptarGroup is headquartered in Crystal Lake, Illinois, with manufacturing facilities in North America, Europe, Asia and South America.

For more information, visit www.aptar.com.

Media Contact: 

Tracey Safran
Business Development Manager
Next Breath
+1 410 455 5904
tracey.safran@nextbreath.net

2018-02-12T23:49:33+00:00 February 12th, 2018|Categories: News|Tags: , , |