Manufacturing Systems, Single-Use

There is no harmonized guidance on pre-use integrity testing of sterilizing filters, prompting discussion among users as to whether such testing is necessary.

A review of key industry shifts and promises for the future.

Industry experts discuss significant achievements. Plus: What's in store for the future.

The authors describe a new assembly for bulk and final drug product filling operations.

Demonstration of large-scale stem-cell scale-up.

This article is the second in a two-part series on extractables and leachables.

This article outlines methods, validation standards, and documentation of sterilization of single-use products using gamma irradiation.

This month, we rewind to "Separations Technology Outlook, Part II: Improved Recovery and Greater Purity."

The author describes automated equipment that uses functionally closed disposables.

Readers react to the economic turmoil of the past year and look longingly forward to 2012.

The authors compare the environmental impact of monoclonal antibody production using fixed-in-place processing and single-use systems.

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

With careful analysis to mitigate risk, disposable technology and process closure can enable adaptable designs and reduced costs.

New technology is designed to improve production efficiency by taking advantage of the properties of single-use bags.

Single-use manufacturing may seem like a new trend, but it has actually been around for almost 30 years, beginning in the early 1980s when filter manufacturers began to make small process-scale plastic filter capsules to replace "junior" size stainless-filter housing assemblies.

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

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.

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

Developing a quality agreement template for single-use systems.

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.

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

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

Single-use conference roundup.

An off-the-shelf, single-use perfusion system.

The authors discuss the use of single-use bioreactors.