Navigation Links
Lyophilization Services of New England Completes Successful FDA Pre-Approval Inspection For Sterile Drug Product

BEDFORD, N.H., June 9, 2015 /PRNewswire/ -- Lyophilization Services of New England, Inc. (LSNE) announced today that they have completed  a successful  Pre-Approval Inspection (PAI) and General GMP Inspection in April 2015.  This inspection clears the way for the 25 Commerce Drive manufacturing site, located in Bedford, NH, to manufacture commercial drug product for US distribution.  The inspection concluded with a recommendation for approval and the Establishment Inspection Report (EIR) has been received.   This is the second PAI at the Commerce Drive facility, the first inspection was for a bulk drug intermediate lyophilized in LSNE's 260 square foot lyophilizer.

Shawn Cain, Chief Operating Officer of LSNE stated, "The completion of this inspection is a critical milestone for LSNE as it is the first PAI for a sterile product at the 25 Commerce Road facility.  This is also our second site to now be successfully inspected by the FDA to produce commercial products in the past few months.  This demonstrates LSNE's commitment to meeting all applicable regulatory standards for the production of commercial medical devices, bulk intermediates and sterile injectable drugs.  It is only through the talent and dedication of our staff that we have been able to achieve and maintain this level of compliance."

LSNE has also added additional capabilities across their three sites and they plan to continue expanding in the coming year(s).  The 2015 master plan includes expansion of QC analytical testing capabilities, ICH stability chambers, additional complex formulation capabilities, as well as adding increased manufacturing capacity. LSNE continues its path towards becoming the premier turn-key CMO for its clinical and commercial clients and its commitment to reduce the time and cost of bringing client projects from bench to market. 

About LSNE Contract Manufacturing

LSNE Contract Manufacturing is a privately held company with three GMP manufacturing facilities located in New England.   LSNE has been providing contract lyophilization services to the pharmaceutical, biotechnology and medical device industries since 1997, specializing in a wide range of services including cycle development, cGMP fill/finish of liquid and lyophilized products.  Through the thoughtful integration of three processing facilities, qualified staffing, and an extensive manufacturing history, LSNE is strategically positioned to provide uninterrupted manufacturing for clinical through commercial supply for medical devices and pharmaceuticals to a multi-national market.

Media Contact
Christine Palus
Vice President of Sales & Marketing
(603) 668-5763  

Logo -

SOURCE Lyophilization Services of New England, Inc.
Copyright©2015 PR Newswire.
All rights reserved

Related medicine technology :

1. Lyophilization Services of New England Completes FDA Inspection
2. Lyophilization Market Worth $5,121.5 Million by 2019
3. Global Freeze Drying / Lyophilization Equipment (Lab, Pilot, & Industrial) Market - Forecast to 2019
4. Armada Announces New Corporate Website to Showcase Expanded Services to Specialty Pharmacy Marketplace
5. Z-Medica Launches New Line of Hemostatic Agents for use in Emergency Medical Services
6. TMA Launches Physician Services Organization for Patient Care
7. Analysis of Global Electronics Manufacturing Services Market Opportunities
8. Liquidity Services, Inc. Selected by Hoffmann-La Roche Inc. as Sales Channel for Surplus Assets
9. Uroplasty Announces Positive Coverage Decision For Percutaneous Tibial Nerve Stimulation By Wisconsin Physicians Services
10. Marketing Services Groups Face Constant Pressure to Evaluate and Evolve their Organization
11. Gerard Design Changes Its Name to Reflect Its Services and Expertise
Post Your Comments:
(Date:7/17/2019)... ... July 17, 2019 , ... Princeton, New Jersey – ... today announced that it has been named a 2019 ‘Cool Vendor’ by Gartner, Inc. ... this year’s Cool Vendors research, we focused on two things. First, given the clear ...
(Date:7/17/2019)... (PRWEB) , ... July 17, 2019 , ... Chlorophyll Water ... at the United Nations for International Yoga Day 2019. , International Day of ... June 21st. The day was declared unanimously by the United Nations General Assembly. , ...
(Date:7/17/2019)... ... 2019 , ... Burn Boot Camp, a nationwide health & ... Their Muscle” philanthropic event, and seventh year since the company’s inception, to support ... dystrophy, ALS and related neuromuscular diseases that severely weaken muscle strength and mobility. ...
Breaking Medicine Technology:
(Date:7/17/2019)... ... 17, 2019 , ... Becker's Healthcare is pleased to recognize ... men and women included on this list lead organizations regularly recognized for patient ... well as the construction of satellite clinics and strategic partnerships with local healthcare ...
(Date:7/17/2019)... MESQUITE, Texas (PRWEB) , ... July 17, 2019 , ... ... partnership with the Smiles for Everyone Foundation . Over 50 underserved patients were ... extractions , and more while celebrating the summer season. Individuals were referred to ...
(Date:7/17/2019)... ... July 16, 2019 , ... A medical home care program ... need is key to better care for seniors. While this may not sound surprising, ... Home (LAJH) through its Brandman Research Institute (BRI) uncovered several surprising outcomes based on ...
(Date:7/13/2019)... ... July 13, 2019 , ... ZALO , the leading luxury ... rechargeable vibrator and clitoral massager. To view the product and its accompanying video click ... most advanced, personal massagers to people around the world,” said Mara Epstein, director of ...
(Date:7/13/2019)... ... July 12, 2019 , ... China Focus ... Center , sponsored by Hangzhou Investment Promotion Bureau, Fox Rothschild LLP, MORE Health ... The conference attracted Fosun Pharmaceuticals, WuXi Biologics, Kelun Pharmaceutical, Harbin Pharmaceuticals, Fountain Medical, ...
Breaking Medicine News(10 mins):