Navigation Links
CMC Biologics Achieves Successful Pre-Approval European GMP Inspection by MHRA for Commercial Manufacturing
Date:6/18/2012

SEATTLE, June 18, 2012 /PRNewswire/ -- CMC Biologics, a leading contract manufacturing organization (CMO) known for its technical excellence in process development and cGMP manufacture, has received a Certificate of Good Manufacturing Practice (GMP) Compliance for commercial manufacturing issued by the Medicines and Healthcare products Regulatory Agency (MHRA).  The MHRA inspected CMC Biologics' manufacturing and testing facilities in Bothell, WA in late March 2012 and issued the certificate based on the positive outcome of the inspection.  

(Logo: http://photos.prnewswire.com/prnh/20110502/SF93356LOGO)

"We are extremely pleased with the results of the recent inspection of our world class manufacturing facility in Bothell.  Our continued commitment toward compliance and high quality systems resulted in the success of this important regulatory milestone," said Gustavo Mahler, Ph.D., Chief Operations Officer of CMC Biologics.  "This achievement demonstrates the viability of our manufacturing, process, and quality systems, which is the foundation for our customers' clinical and commercial success."

In response to the growing demand of customers, CMC Biologics expanded its state-of-the-art stainless steel biopharmaceutical manufacturing facility.  This expansion added significant production capacity to accommodate additional cGMP manufacture of biopharmaceuticals and to support added demand for commercial manufacturing in a multi‑purpose facility.

About CMC Biologics

CMC Biologics is a leading contract development and manufacturing organization that provides fully integrated biopharmaceutical development and manufacturing solutions to clients around the world, from its facilities in Europe and the USA.  The company has proven expertise in delivering custom solutions for the scale-up and cGMP manufacture of protein-based therapeutics for pre-clinical, clinical trials and in-market production.  The company's wide range of integrated services includes cell line development, bioprocess development, formulation and comprehensive analytical testing.  Clients can also benefit from CMC Biologics' proprietary CHEF1® expression system for mammalian production.  CMC Biologics has fully segregated microbial fermentation and mammalian cell culture suites and offers both fed-batch and perfusion production processes.  CMC Biologics is located in Copenhagen, Denmark, and Seattle, Washington. Visit www.cmcbio.com  to learn more.


'/>"/>
SOURCE CMC Biologics
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Chinese Compulsory Immunization Program for Livestock Creates Massive Opportunity for Animal Vaccines and Biologics Developers
2. Avaxia Biologics Announces Appointment of Michael D. Rivard as VP Corporate Development
3. CSL Behring Announces FDA Filing of Biologics License Application for 4-Factor PCC for Urgent Reversal of Vitamin K Antagonist Anticoagulant Therapy
4. Avaxia Biologics is Awarded U.S. Patent for Method to Treat Radiation Damage to the Digestive Tract and Mucositis Caused by Radiation
5. Synthetic Biologics Appoints Carol Reed, M.D., as Senior Vice President of Clinical & Regulatory Affairs
6. Althea Technologies Appoints Dr. Kristin DeFife, Director, Biologics Manufacturing And Jack Wright, VP, Sales and Marketing
7. Acuo Technologies Grows European Business and Achieves Successful Connectathon Results in Bern, Switzerland
8. Greenville Hospital System Achieves Dramatic Improvement in Hand Hygiene Compliance Rates Using New Technology from DebMed®
9. Pharmos Corporation Announces Successful Completion Of Proof-of-concept Clinical Trial Of Levotofisopam For The Treatment Of Gout
10. AXIOS™ Stent and Delivery System Study Demonstrates Successful Treatment of Pancreatic Pseudocysts and Acute Cholecystitis
11. Novelos Therapeutics Successfully Completes First Cohort In Phase 1b Solid Tumor Trial With I-131-CLR1404 (HOT) Cancer-Targeted Molecular Radiotherapeutic
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/29/2016)... ISELIN, New Jersey , April 29, 2016 ... Omnichannel Software Suite for Life Sciences, Product Development ... and Global Life Science Customer Base . ... healthcare solutions provider, today announced the acquisition of ... is a global leader in adaptive sales enablement ...
(Date:4/29/2016)... April 29, 2016 Glycotope GmbH, ... today announces the appointment of Dr. Alfredo Zurlo ... is an oncologist with many years clinical experience and ... industries. His last role was at Mologen AG where ... Executive Board. Previously Dr. Zurlo held various positions at ...
(Date:4/28/2016)... April 28, 2016   Click here for ... Inc. (NYSE: DPLO), the nation,s largest independent specialty ... definitive agreement to acquire Valley Campus Pharmacy, Inc., ... a leading specialty pharmacy that provides individualized patient ... . In 2015, TNH generated approximately $400 ...
Breaking Medicine Technology:
(Date:5/1/2016)... ... , ... ProBrand Reveal Volume 2 is a set of versatile and smooth logo reveals built ... users can easily create a unique logo reveal in just a matter of minutes. Custom ... these title presets to add a uniquely animated logo to any photos or videos. , ...
(Date:4/30/2016)... ... May 01, 2016 , ... Serenity Recovery, a substance abuse ... produced a new video that focuses on one of the more popular of their ... clips from interviews with a participating patients and the Yoga class instructor, this video ...
(Date:4/30/2016)... , ... April 30, 2016 , ... ... announced RANKED Health , a program to critically evaluate and rank health-focused ... of the program is to provide independent, unbiased and accurate information to help ...
(Date:4/30/2016)... ... April 30, 2016 , ... ... 4th, 2016 questioned the use of the HyProCure sinus tarsi implant. ( ... procedure.” EOTTS-HyProCure is a minimally invasive procedure performed, when indicated, to correct ...
(Date:4/29/2016)... ... 30, 2016 , ... World Patent Marketing , a ... an automotive invention that improves the storage features of a pick up truck. ... Scott Cooper, CEO and Creative Director of World Patent Marketing. "Over the next ...
Breaking Medicine News(10 mins):