BioPharm International, September 2007 - BioPharm International

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BioPharm International, September 2007
Features
Evaluation of an Instantaneous Microbial Detection System in Controlled and Cleanroom Environments
By Vishvesh K. Bhupathiraju , Brandon Varnau , Jerry R. Nelson , J. P. Jiang , Chuck Bolotin
Columns and Departments
Street Talk: Summer No Picnic for Investors
By Brian O'Connell
Closer examination shows there's a strong bond between the biotech market and the unraveling credit markets.
Outsourcing: Robust Market Testing CROs' Ability to Deliver
By Jim Miller
Meeting service levels is a major challenge for pharmaceutical services providers because the requirements of their client base vary widely.
Final Word: In the Quest to Manage Capacity, Biology Trumps Stainless Steel
By Michael E. Kamarck
From the earliest days of the biotechnology industry, companies have grappled with the complexities of making innovative biopharmaceuticals on a large scale. Success in manufacturing begins with process science, since biotech production requires perfection in maintaining living organisms in a sterile environment under controlled physiological conditions. But unless companies can solve the challenge of planning for and managing manufacturing capacity, they will not be able to achieve the full potential of promising biotech products.
FDA Leglislation Tackles Safety Issues
By Jill Wechsler
The new legislation authorizes the use of fee revenues for drug safety oversight and assessment throughout a product's lifecycle.
From the Editor: Issues of Scale
By Laura Bush
In analyzing the industry's current challenges, let's be careful before extrapolating about what they mean.
IP Briefs: The Shifting Landscape of Patent Licensing
By Jennifer Carter
In light of these recent decisions, patent holders must devise new strategies for patent enforcement and licensing.

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