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BioPharm International-05-01-2008
BioPharm International
An Underfunded FDA Fights Back
May 01, 2008
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The FDA is under attack from all sides. Many influential members of Congress either don't trust the agency to monitor the industry appropriately, or have found it politically expedient to keep sounding alarms about inadequate oversight of food and drug safety and clinical research. The good news is that there seems to be a growing consensus that FDA needs a major infusion of cash to regain its stature as an effective science-based regulatory agency.
Impact of Lot-to-Lot Variability of Cation Exchange Chromatography Resin on Process Performance
May 01, 2008
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Understanding the impact on process performance.
India's Clinical Trials Market Accelerates
May 01, 2008
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Most local and global clinical research organizations (CROs) consider an operational presence in India as key to their overall business plans. India is clearly on course to become the next hub for clinical trials.
Straightforward Guidance
May 01, 2008
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In the context of process validation, the confirmation of a belief must be checked repeatedly, throughout the product lifecycle.
Coming to Biotech Near You: Quality by Design Part 1: Its Applicability in Biopharmaceuticals
May 01, 2008
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The principles of QbD can be applied to biotech development and manufacturing to help resolve many common issues. QbD scientifically provides a greater understanding of the complex relationships among product quality attributes, the manufacturing process, and clinical safety and efficacy by determining the various permutations of critical input variables that will keep the product within specification.
Biomanufacturing Pendulum Swings Toward Overcapacity
May 01, 2008
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The current overcapacity situation in the bio/pharmaceutical industry is a reminder that CMOs need to come up with business models and value propositions that are based on more than just selling capacity.
Harvest and Recovery of Monoclonal Antibodies from Large-Scale Mammalian Cell Culture
May 01, 2008
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A comparison of primary harvest techniques.
Managing the Global Supply Chain
May 01, 2008
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Recent problems with food and pharmaceutical ingredients sourced from China highlight a major disadvantage of our complex international supply chains for food and drug ingredients. A global supply chain offers more opportunities for accidental contamination as well as intentional adulteration and counterfeiting. Sticking to minimal requirements may not be enough.
Cumulative Sum Charts for Problem Solving
May 01, 2008
Features
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CUSUM charts are easy to create in Excel and can reveal when a change occurred.