By Cathy Yarbrough, Contributing Editor
The industry leader in developing antibiotics against “superbugs” and other multidrug-resistant bacteria is not a Big Pharma corporation, but Cubist Pharmaceuticals, headquartered in Lexington, MA.
By James Glenn and Claudia M. Huether
This application note describes the integration of a Thermo Scientific® Prima® dB Mass Spectrometer (MS) with DASGIP Parallel Bioreactor Control Systems implemented at Gevo®, Inc. in Englewood, CO. The availability of real-time MS data will aid in maximizing cell growth and isobutanol production.
By Marlin Frechette, Director, Regulatory Affairs and Quality Systems, Irvine Scientific
Protecting your raw materials is a vital part of your process — and one that should be taken seriously. Repercussions such as plant shut-downs and drug shortages — stemming from events such as virus contamination — can be far-reaching and difficult to overcome. To help safeguard your product, and to avoid potential adverse events, you can keep the following things in mind when sourcing media.
By Trisha Gladd, Editor, Bioresearch Online
As single-use systems continue to gain in popularity, so does the use of single-use bags. A single contract manufacturer can use thousands of bags per year. Gallus Biopharmaceuticals has used more than 40,000 bags in just the past decade. Due to the volume increases in some of these bags, the prevention of possible contamination issues has never been more important. More pharma manufacturers are now looking to perform point-of-use tests to ensure the integrity of the bags they are using.
By Linda Kim, General Manager, Marken Korea
As a professional working in the pharmaceutical research and development industry, Mrs. Tan was also a mother of twins. She found herself in search of a safe and secure means to transport expressed breast milk across Asian borders to her infants back home.
Featuring Carrie Magillivray, Program VP Mobile Services, M2M and Network Infastructure
New applications for tracking of cargo and assets that are time- and temperature-sensitive and of significant value.
By Milton Boyer, President, OSO Biopharmaceutical Manufacturing
The changing regulatory environment is shaping a new paradigm between drug sponsors and contract manufacturing organizations (CMOs). One key aspect is demonstrated quite nicely in a case study from February 2012 (read it here), when the FDA issued a warning letter to a contract manufacturing organization. The warning letter stated in part:
“In your response, you state that you have informed your clients on the importance of validating the methods, but they have chosen not to validate the methods. In addition, you state that you will inform them again in writing. Your response, however, is inadequate because you do not provide your firm's planned corrective actions for this cGMP violation. You are responsible for ensuring that the test methods used by your firm are validated.” (Emphasis added)