BioPharm International Supplements, April 2007 - BioPharm International

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BioPharm International Supplements, April 2007
Articles
Outsourcing Virtually Everything: Making the Semi-Virtual Model Work
By Harry Atkins
Partnering with a surging number of CROs, CMOs, CSOs, and other niche providers, biopharm companies in 2007 will have an estimated spend of more than $7 billion on international clinical trial outsourcing alone.
The Importance of Project Management
By Magdalena R. Mejillano , Chris Lively , Stacey Miller
Are the deadlines for your outsourced projects often not met? Are you unsure of the status of your project at any given time? Is the original budget of your study typically exceeded?
Match.Contractmanufacturing: Finding The Perfect Match
By Max Horn
The contract manufacturer must have sufficient capacity so it can absorb possible surge in demand, and back-up capability in case of a power failure or other event.
Outsourcing: What is the Path Forward?
By William Kerns
The greatest benefits of outsourcing are realized when a company takes a strategic approach rather than a tactical approach.
Analytical Testing to Support Biopharmaceutical Products
By Jon S. Kauffman, PhD
A tremendous amount of analytical testing is required to support a biopharmaceutical product from discovery, development, and clinical trials, through manufacturing and marketing. Numerous methods are used to fully characterize large molecules because of their complexity—characterizing them is significantly more difficult than it is for small molecules. Biopharmaceuticals are produced via living systems, i.e., E. coli, yeast, or mammalian cells, which require additional testing matrices.
Successful Steps for Outsourcing the Manufacture of Clinical Trials Materials
By Susan Cameron
Consider the number of patients, the dose each will receive (and how this dose is calculated), the number of doses per patient, and what overage is needed to allow for vial breakage.

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