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Coming to Biotech Near You: Quality by Design Part 1: Its Applicability in Biopharmaceuticals
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Conrad J. Heilman, Jr., PhD
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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.
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Managing the Global Supply Chain
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Paula J. Shadle, PhD
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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.
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India's Clinical Trials Market Accelerates
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Eric S. Langer
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Faiz Kermani, PhD
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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.
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Straightforward Guidance
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Laura Bush
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In the context of process validation, the confirmation of a belief must be checked repeatedly, throughout the product lifecycle.
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An Underfunded FDA Fights Back
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Jill Wechsler
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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.
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Biomanufacturing Pendulum Swings Toward Overcapacity
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Jim Miller
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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.
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