BioPharm International, November 2007 - BioPharm International

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BioPharm International, November 2007
Features
Increasing Lyophilization Productivity, Flexibility, and Reliability Using Liquid Nitrogen Refrigeration–Part 1 of 2
By Balazs Hunek, PhD , Alan Cheng, PhD , John Capettini
A History of the OOS Problem
By Steven S. Kuwahara
Contrary to popular belief, the out-of-specification problem started years before the Barr Decision.
What Follow-on Biologics Mean for the Future of the Biotechnology Industry
By Ajaz S. Hussain, PhD , Gillian Woollett
The industry needs a clear regulatory pathway for the approval of biosimilars.
Engineering Biopharmaceuticals
By Gary Walsh, PhD
An overall increasing proportion of future product approvals will be engineered in some way, either directly or indirectly.
Columns and Departments
Biotechnology and Life Sciences Education in China
By Eric S. Langer , Eliza Yibing Zhou
Biotechnology is definitely a hot topic in China—the country's administrators recently identified it as a "cornerstone of China's national economy by 2020." But most realize that getting there will require a better trained, specialized workforce than currently exists. The Chinese government has been pumping money into life sciences education as part of its plan to achieve a global biotechnological presence over the next 15 years.
Venture Funding Returns to Life Sciences
By Brian O'Connell
The biopharmaceutical sector can look forward to a financially flush venture funding environment in 2008
The Difficulty of Giving Things Up
By Laura Bush
The challenge is not in coming up with a list of activities to discard, but in finding a feasible way to stop doing them.
How to Develop a Pool of Talented People
By John W. Dobiecki
CMOs must take a proactive approach to ensure the availability of local talent
How to Make Improvement Programs Work
By Marc Puich
A true visionary leadership is required to drive the progress of operational excellence programs in biopharmaceutical organizations
FDAAA Boosts Fees, Broadens Disclosure
By Jill Wechsler
Congress postpones debate on follow-on biologics while adopting new policies likely to reshape drug development

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