Manufacturing

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.

An evaluation of the technologies needed to develop a safe, effective, and economically efficient vaccine. This article is part of a special section on vaccines.

A Q&A with Rick Hancock, president of Althea Technologies. This article contains bonus online material.

A survey provides insight into drug companies' plans for spending on outsourced services. This article contains bonus online material.

The authors provide insight into microRNA biology, and the simplicity of anti-miR oligonucleotide drug delivery.

The International Society for Pharmaceutical Engineering (ISPE) will soon publish an update for its guide to sterile-product manufacturing facilities. The new publication will replace the original guide, ISPE Baseline Guide: Sterile-Product Manufacturing Facilities, and contain practical information about technological advances in sterile manufacturing.

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 re-examine environmental controls in the context of technical advances in manufacturing.

Incorporating regulatory requirements into the product life cycle is crucial.

The authors describe challenges faced in transfer and scale-up of a fermentation process.

Plasmid DNA-encoding proteins offer many advantages, which are now being used in clinical trials.

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

Single-use conference roundup.

The authors present a case study identifying a contaminant.

Clear documentation and open communication are essential for effective technology transfer.

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

Addressing supply-chain challenges.

Nigeria Looks to Simple Packaging Controls and International Cooperation to Curb Counterfeit Drugs

Supply-chain analytics can lead to increased profitability.

The authors present lessons learned from a case study of the transfer of a cell culture biotherapeutic process to a CMO.

The authors discuss the use of single-use bioreactors.