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Separation & Purification: Endotoxin Reduction Using Disposable Membrane Adsorption Technology in cGMP Manufacturing

May 1, 2007

Membrane-based chromatography technologies sometimes offer advantages over resin-based technologies.

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?

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.

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.

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.

Regulatory Beat: FDA Moves to Streamline Manufacturing Supplements

April 1, 2007

The challenge will be to design a system that is flexible, yet appropriate, for the broad range of biological products and the varying quality control capabilities of different manufacturers.

Manufacturing: BioPharmaceutical Operations Roadmap 2007

April 1, 2007

Scale-up issues leading to long development times and deviations in the commercial facility is a critical challenge.

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