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:6/23/2016)... , June 23, 2016 Research ... MEMS Devices Medical Market Analysis 2016 - Forecast to 2022" ... The report contains up to date financial data ... analysis. Assessment of major trends with potential impact on the ... analysis of market segmentation which comprises of sub markets, regional ...
(Date:6/23/2016)... , June 23, 2016 , ... on Thursday, July 7, 2016 , , , , LOCATION: ... , , , , EXPERT PANELISTS:  , , , ... Senior Industry Analyst, Christi Bird; Senior Industry Analyst, Divyaa Ravishankar and ... The global pharmaceutical industry is witnessing an exceptional era. ...
(Date:6/23/2016)...  Guerbet announced today that it has been named ... . One of 12 suppliers to receive ... support of Premier members through exceptional local customer service ... to lower costs. ... outstanding customer service from Premier," says Massimo Carrara ...
Breaking Medicine Technology:
(Date:6/24/2016)... ... ... Marcy was in a crisis. Her son James, eight, was out of control. Prone to ... , “When something upset him, he couldn’t control his emotions,” remembers Marcy. “If there ... my other children and say he was going to kill them. If we were ...
(Date:6/24/2016)... ... June 24, 2016 , ... Global law firm Greenberg Traurig, P.A. announced that ... chosen by their peers for this recognition are considered among the top 2 percent ... special honors as members of this year’s Legal Elite Hall of Fame: Miami ...
(Date:6/24/2016)... ... June 24, 2016 , ... Comfort Keepers® of San Diego, ... and the Road To Recovery® program to drive cancer patients to and from their ... to ensure the highest quality of life and ongoing independence. Getting to and ...
(Date:6/24/2016)... ... June 24, 2016 , ... People across the U.S. are sharpening their pencils ... an essay contest in which patients and their families pay tribute to a genetic ... 2016 National Society of Genetic Counselors (NSGC) Annual Education Conference (AEC) this September. ...
(Date:6/24/2016)... York, NY (PRWEB) , ... June 24, 2016 ... ... publication Haute Living, is proud to recognize Dr. Barry M. Weintraub as a ... that “the most beautiful women in the world, and the most handsome men, ...
Breaking Medicine News(10 mins):