08.14.14 -- How To Prepare A Facility For The Biopharmaceutical Revolution; What You Missed From The FDA Last Week
Are You Properly Selecting Your CMO Partners? By Ed Miseta, Chief Editor, Outsourced Pharma and Clinical Leader
Angie Green, an external manufacturing and supply chain leader with 16+ years of experience, has a remarkable understanding of the sponsor/CMO relationship. Her presentation on the steps sponsors should follow when selecting CMO partners is so informative and are echoed in many of the conference sessions for Outsourced Pharma West Conference.
For more insight on outsourcing strategies and CMO partners, Register Today for Outsourced Pharma West Conference and Exhibition.
By Trisha Gladd, Editor, Pharmaceutical Online and Bioresearch Online
Drug discovery is an inherently inefficient process. It takes thousands of failed compounds before one can get approved as safe and efficacious, and this effort does not come at a low cost. Because of this, the industry is constantly looking for ways to bring safe, compliant, and profitable drugs to market faster and cheaper. The Patheon facility, in Brisbane, Australia, exemplifies the facility needed to survive the future of pharma. But how did they do it?
By Frank Bieganousky, Founding Member, Montesino Associates, LLCBy Frank Bieganousky, Founding Member, Montesino Associates, LLC
Whether it comes from the global market or a national regulatory body, implementing a track-and-trace system is a complex, expensive, and resource-intensive endeavor. It is complex since there are numerous technical and design challenges, expensive since it can involve many and varied pieces of equipment, and resource intensive since it needs cross-functional teams and top management involvement.
By Tara S. Hundley, Anton Paar USA
For those of you who work with any analytical, lab, or process instruments, you know that staying in compliance with global regulations has become burdensome in the past decade. Everyone is fixated on streamlining production processes and reducing the bottom line. This means getting new instruments into the workflow as soon as possible; but to do so you need to know everything there is to know about equipment and instrument qualification. In the overall pharmaceutical manufacturing process you may be just one cog on the gear of productivity, but without some help, you could go from cog to clog very quickly.
By Jean Bédard, President and CEO, Infitrak
As pharmaceuticals have become more and more regulated, companies have had the need to build or evaluate their cold chain processes and packaging to comply with those regulations and minimize risk.
The 12th Cold Chain Global Forum, taking place September 29 to October 3 at the Hynes Convention Center in Boston, MA, gathers more than 750 supply chain stakeholders for the largest worldwide event covering all temperature ranges and life sciences products. Life Science Leader subscribers receive 20 percent off standard rates with code 12CCGF_LIFESCILEAD. Learn more.