BioPharm International, November 2011 - BioPharm International

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BioPharm International, November 2011
Features
CMOs Ratchet up use of Single-Use Devices to Improve Performance
By Eric S. Langer
Single-use systems continue to gain traction among biomanufacturers, especially CMOs.
Biobetters and the Future Biologics Market
By Niall Dinwoodie
Despite their difficult approval pathway, biobetters offer the potential for innovation and decreased healthcare costs.
Development and Commercialization of Biosimilars in India
By Anurag S. Rathore
The author explains the current status of India, the challenges, and recommendations that may alleviate these challenges.
Integrity Testing of Flexible Containers
By Vishwas Pethe , Mike Dove , Alex Terentiev
Defects as small as 10 μm can be detected without compromising product cleanliness using helium integrity testing.
Protein Engineering
By Trevor J. Hallam , Christopher J. Murray
Industrializing design, development, and manufacturing of therapeutic proteins.
From the Editor
Passion, Innovation, and Loss
By Michelle Hoffman
At a time when the industry is struggling with innovation, it might do well to learn a lesson from a few great innovators.
Regulatory Beat
Drug Shortages Create Crisis for Manufacturers, Regulators
By Jill Wechsler
Clamor mounts over compromised care and rising costs due to lack of crucial therapies.
Disposables Advisor
Focus on Standardization, Quality by Design, and Regulatory GMP
By Jerold Martin
In this quarter's column, highlights from the IBC Single-use Applications meeting, the PDA Single-use Workshop, and the BioProcess systems Alliance International Single-Use Summit are presented.
Perspectives on Outsourcing
Biosimilars' Technology Needs
By Eric S. Langer
Biosimilar manufacturers need better expression systems and analytical tools to compete.
Compliance Notes
Developing and Sustaining a Quality Culture
By Ian Uydess , Chet Meyers
In a culture of quality, it is important that employees adopt this mindset, not because they have to, but because they understand the importance.
Final Word
The Economic Challenge of Prescription–Diagnostic Combinations
By Gerry McDougall
With the rise in therapeutics comes more complex partnerships.

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