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Final Word: Political Will is the Backbone of Regulation Enforcement

May 1, 2007

Lax enforcement arising from a lack of political will creates the potential for a loss of public confidence.

Analytical Testing to Support Biopharmaceutical Products

April 2, 2007

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.

Match.Contractmanufacturing: Finding The Perfect Match

April 2, 2007

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?

April 2, 2007

The greatest benefits of outsourcing are realized when a company takes a strategic approach rather than a tactical approach.

The Importance of Project Management

April 2, 2007

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?

Successful Steps for Outsourcing the Manufacture of Clinical Trials Materials

April 2, 2007

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.

Outsourcing Virtually Everything: Making the Semi-Virtual Model Work

April 2, 2007

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.

Quality: Design Space for Biotech Products

April 1, 2007

Process monitoring ensures that the process performs within the defined acceptable variability that served as the basis for the filed design space.

Filtration:Vendor Notes: The Effect of Flux Decay on a 20-nm Nanofilter for Virus Retention

April 1, 2007

Although contaminants and other parameters may be main causes of filter breakdown, some nanofilters still remove viruses at high Log Reduction Value (LRV).

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