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.