This Day On The Street
Continue to site
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

CMC Biologics Achieves Authorization For CGMP Commercial Manufacturing By The Danish Medicines Agency

COPENHAGEN, Denmark and SEATTLE, Oct. 15, 2013 /PRNewswire/ -- CMC Biologics has received renewal of its manufacturing and importation authorization (MIA) for Good Manufacturing Practice (cGMP) production of clinical and commercial manufacturing from the Danish Medicines Agency (DKMA), a division of the Danish Health and Medicines Authority. The DKMA inspected CMC Biologics' optimized manufacturing and testing facilities in Copenhagen, Denmark in late May, and issued the certificate based on the positive outcome of the inspection.   

"This important regulatory milestone helps drive our strategy to satisfy our customers' growing clinical and commercial cGMP manufacturing requirements, and takes this site to the next level as a global leader in commercial production of protein therapeutics," said Patricio Massera, General Manager of CMC Biologics Copenhagen.  "We are committed to the highest quality standards and extremely pleased with the results of the agency's inspection."

CMC Biologics made an important capital investment in its biopharmaceutical manufacturing facility which optimizes segregation of unit operations and improves flow of materials and personnel. The enhanced layout now maintains a fully unidirectional return corridor and exit airlocks to achieve exceptional manufacturing quality standards. The updated MIA is available on the EudraGMP database at http://eudragmp.ema.europa.eu; authorization number 26415.

Massera adds, "Our vision is to be considered the global market leader of customer satisfaction for contract biopharmaceutical process development and manufacturing services. This facility expansion and successful regulatory inspection represents another step toward making that vision a reality."

About CMC Biologics

CMC Biologics is leading the industry among CMO's in reliability, technical excellence, and quality – Right and On Time.  With three facilities in the USA and Europe, the Company provides fully integrated biopharmaceutical development and manufacturing solutions to clients globally. 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 commercial 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' facilities are located in Copenhagen, Denmark; Seattle, Washington; and Berkeley, California. More detailed information can be found at www.cmcbiologics.com.

SOURCE CMC Biologics

Copyright 2011 PR Newswire. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
SYM TRADE IT LAST %CHG

Markets

Chart of I:DJI
DOW 16,491.28 -151.73 -0.91%
S&P 500 1,974.78 -14.09 -0.71%
NASDAQ 4,786.4570 -41.8680 -0.87%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs