BioPharm International, August 2010 Issue (PDF)
Facilitate Cell Culture Process Development
Downstream Disposables: The Missing Link in the Disposables Chain
Although single-use systems are widely used in upstream unit operations, their acceptance in downstream processes has been slow.
Tug of War
Regulatory relief requires that regulators trust companies to know what they are doing, and to do it-consistently.
Spanning the Globe
This month, we catch up on major developments around the world and their implications for the contract services industry.
Technical and Economic Benefits of Membrane Chromatography During Polishing Steps
An analysis of flow rate, load density, viral clearance, and cost.
Meningitis Vaccine Purification: Quality Control of Ultrafiltration Membrane Porosity
How to balance porosity, plugging, and lot-to-lot variability in filters.
Myriad Decision Places Biotech at a Crossroads
In light of the new ruling, patent licensees may want to re-evaluate the strength of their licensed patents.
Manufacturing Compliance in the Spotlight
Plant closures, product recalls prompt FDA re-evaluation of GMP enforcement efforts.
Disposable Systems as a Platform Technology for R&D and Clinical Supply
How a Big Pharma company tackled the move to disposable bioreactors.
USP <63> Mycoplasma Tests: A New Regulation for Mycoplasma Testing
What you need to know about USP chapter <63>.
Development of a Novel Rolling-Tube Cell Culture Platform and Demonstration of System Feasibility
Rolling-tube system balances scale-up accuracy and thoroughput.