BioPharm International
July 01, 2012
Issue PDF
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A New Era in Cell Culture Media Development
July 01, 2012
Features
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Steven S. Kuwahara, PhD, principal consultant at GXP BioTechnology LLC, gives an update on "Engineering the Cell-System Interface."
July 01, 2012
Perspectives on Outsourcing
25
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Industry wants more innovation, but can suppliers meet customers' needs?
July 01, 2012
Features
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This article contains online-exclusive supplemental material for Malik's article entitled, "Allogenic Versus Autologous Stem-Cell Therapy."
July 01, 2012
Burrill on Biotech
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Collaborative R&D models coincide with new ways to fund translational research.
July 01, 2012
Compliance Notes
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Unnecessary analytical testing can lead to unnecessary costs.
July 01, 2012
From the Editor
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Although FDA cannot do anything to stop drugs from being discontinued, it can do something about supply and quality problems that lead to shortages.
July 01, 2012
Features
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The author discusses potential manufacturing costs & challenges of allogeneic & autologous stem-cell therapy.
July 01, 2012
Features
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Industry experts discuss methods for optimizing protein expression in bacterial and mammalian cell lines.
July 01, 2012
Boot Camp Business Guide
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Selection of the right cell line, culture medium, and bioreactor conditions is key to setting up the upstream portion of the biopharmaceutical manufacturing process.
July 01, 2012
Features
25
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Cell-line specific complex media supplements combine chemically defined media additives into a single supplement.
July 01, 2012
Regulatory Beat
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Multiple initiatives are moving forward to maintain US leadership in biopharm R&D.
July 01, 2012
Features
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The authors present scale-up from a 5-L fermentor to a 50-L pilot-scale using the criterion of constant power consumption per unit liquid volume.
July 01, 2012
Manufacturing Best Practices
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Harmonized regulations call for a risk-based and systematic approach to evaluating and selecting CPPs.