Articles on disposables: implementation, validation, cost-benefit analysis - BioPharm International


The advantages and disadvantages of disposables, along with cost-benefit analyses, validation strategies, and implementation approaches.

The Evolution from Fixed to Single-Use Systems

November 2, 2011

An overview of applications for disposable components and important property considerations.

Focus on Standardization, Quality by Design, and Regulatory GMP

November 1, 2011

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.

CMOs Ratchet up use of Single-Use Devices to Improve Performance

November 1, 2011

Single-use systems continue to gain traction among biomanufacturers, especially CMOs.

Integrity Testing of Flexible Containers

November 1, 2011

Defects as small as 10 μm can be detected without compromising product cleanliness using helium integrity testing.

Single-use Technology: Balancing the Risks and Rewards

September 2, 2011

Developing a quality agreement template for single-use systems.

Navigating the Biosimilars Market

September 2, 2011

The market landscape for biosimilars is in flux, with limited penetration now, but with the potential for growth for those who can navigate the market. Plus: A SWOT analysis of biosimilars by Anjan Selz.

Particulate Quality of Single-Use Filling Systems

August 1, 2011

The author looks at strategies to minimize particle levels in the finished product when using single-use technologies downstream of final capabilities.

Biopharmaceutical Manufacturing Using Blow–Fill–Seal Technology

July 1, 2011

The authors give special consideration factors affecting blow–fill–seal technology.

Single-Use Technologies World Tour

June 1, 2011

Single-use conference roundup.



Click here