SHL talks about Autoinjector Development in Manufacturing Chemist’s latest issue
pharmafile | March 14, 2012 | Feature | Manufacturing and Production | auto injector, autoinjector, manufacturing chemist, pen injector, shl group
Manufacturing Chemist, an established publication in the biopharmaceutical industry, recently approached SHL to share with their readers the company’s knowledge and experience from working with numerous autoinjector development projects. The article is based on the recently published white paper “Autoinjectors: From Planning to Launch” but provides the content in a more condensed manner.
Abstract
The autoinjector is one of the fastest emerging drug delivery solutions. It consists of a pre-filled syringe or cartridge inside a device that applies enough force to inject fully the desired drug within the specified requirements. Insufficient planning and early conceptual design vulnerabilities can result in quality issues, prolonged project timeline and increased cost. A device manufacturing partner will therefore need basic mechanical device knowledge and regulatory experience.
Many new drugs require innovative devices such as autoinjectors for drug delivery. Medical device developer SHL Group discusses how to plan their development.
Looking at self-administration therapy trends, injectable drug delivery devices such as pen injectors, autoinjectors and needle-free injectors show significant growth potential. It is estimated that the market for pen systems and autoinjectors will reach US$870m (€654m) in 2013 and $1.07bn (€804m) in 2015.1 Industry analysts estimate that more than 30% of all new product submissions to the FDA are combination products.2 Among these, the autoinjector is one of the fastest emerging drug delivery solutions.
While the autoinjector is now considered commercially suitable for the delivery of therapeutic drugs, to develop such a device successfully requires detailed planning, combination product knowledge, regulatory awareness and close collaboration with a carefully chosen device manufacturer.
An autoinjector consists of a pre-filled syringe (PFS) or cartridge inside a device that applies enough force to inject fully the desired drug within the specified requirements. Both of these components are regulated and together define the autoinjector as a combination product.
Full Article (To read the full article, you need to be a subscribed reader for Manufacturing Chemist.)
About SHL
SHL is the world’s largest privately-owned designer, developer and manufacturer of advanced drug delivery devices. We have over 1,800 staff globally, with our primary design centers located in the USA and Sweden and manufacturing centers located in Asia.
SHL supplies autoinjectors, pen injectors and inhaler systems to global pharmaceutical and biotech companies. Significant investment in R&D has enhanced our broad pipeline of “next generation” drug delivery systems. These innovative devices include a range of disposable and reusable injectors with fixed or variable dosing, enhanced precision and the ability to accommodate high viscosities.
Our organization consists of three distinct group companies:
SHL Medical
Designs, develops and manufactures advanced drug delivery devices for leading pharmaceutical and biotech companies
SHL Healthcare
Develops and manufactures equipment solutions for home, hospital and long term care use
SHL Technologies
Provides contract manufacturing and engineering services for the production of complex medtech and industrial products
For additional information visit www.shl-group.com or contact us at info@shl-group.com
SHL Media Contact
Steven R. Kaufman
Marketing Director
pr@shl-group.com
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