Injectable Extractable and Leachable Services Announced by Next Breath

Injectable Extractable and Leachable Services Announced by Next Breath


Press Release | Aptar Pharma

FEBRUARY 02, 2018

Baltimore, Maryland: – 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 or visit their website at:

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.
For more information, visit:

About Aptar Pharma

Aptar Pharma is part of AptarGroup, Inc., 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:

Media Contacts

Tracey Safran
Business Development Manager, Next Breath
Tel: +1 410 455 5904


Click on Injectable Extractable and Leachable Services Announced by Next Breath for other information.
Click on
Aptar Pharma to contact the company directly.

Supplier Information
Supplier: Aptar Pharma
Address: Aptar Radolfzell GmbH, Oeschlestrasse 54-56, 78315 Radolfzell, Germany
Tel: +49 7732 801 0
Fax: +49 7732 801 226

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