BioPharm International, July 2012 - BioPharm International

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BioPharm International, July 2012
Features
Scale up of Fed-Batch Culture to Produce Plasmid DNA in Escherichia coli (Peer Reviewed)
By Odalys Ruiz Hernández , Jorge Valdes Hernández , Willy Frometa Planche , Michel Diaz Martínez , Daniel Alvares Almiñaque , Marta Pupo Peña , Miladys Limonta Fernández , Dinorah Torres Idahody, PhD , Eduardo Martínez, PhD
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.
Optimizing Expression Systems
By Amy Ritter, PhD
Industry experts discuss methods for optimizing protein expression in bacterial and mammalian cell lines.
A New Era in Cell Culture Media Development
By Sally Grosvenor
Cell-line specific complex media supplements combine chemically defined media additives into a single supplement.
Allogeneic Versus Autologous Stem-Cell Therapy
By Nafees Malik
The author discusses potential manufacturing costs & challenges of allogeneic & autologous stem-cell therapy.
Supplementary Material for Allogeneic Versus Autologous Stem-Cell Therapy: Manufacturing Costs and Commercialization Strategies
By Nafees Malik
This article contains online-exclusive supplemental material for Malik's article entitled, "Allogenic Versus Autologous Stem-Cell Therapy."
A 25-Year Retrospective on Bio-Engineering
By Steven S. Kuwahara
Steven S. Kuwahara, PhD, principal consultant at GXP BioTechnology LLC, gives an update on "Engineering the Cell-System Interface."
From the Editor
The Truth About Drug Shortages
By Angie Drakulich
Although FDA cannot do anything to stop drugs from being discontinued, it can do something about supply and quality problems that lead to shortages.
Regulatory Beat
Biotech Innovation Gains Support in Washington
By Jill Wechsler
Multiple initiatives are moving forward to maintain US leadership in biopharm R&D.
Burrill on Biotech
Pharmaceutical Dealmaking Broadens its Partnering Base
By G. Steven Burrill
Collaborative R&D models coincide with new ways to fund translational research.
Compliance Notes
Reduce Analytical Testing and Costs Without Compromising Compliance
By J. Michael Rutledge , Chet Meyers
Unnecessary analytical testing can lead to unnecessary costs.
Perspectives on Outsourcing
Biomanufacturing Innovation
By Eric S. Langer
Industry wants more innovation, but can suppliers meet customers' needs?
Boot Camp Business Guide
Considerations for Successful Upstream Process Development
Selection of the right cell line, culture medium, and bioreactor conditions is key to setting up the upstream portion of the biopharmaceutical manufacturing process.
Manufacturing Best Practices
Using a Systematic Approach to Select Critical Process Parameters
By Thomas A. Little, PhD
Harmonized regulations call for a risk-based and systematic approach to evaluating and selecting CPPs.

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