The evolution of therapeutic modalities drives the adoption of single-use technologies.
Despite a growing number of biosimilar approvals, market uptake remains a challenge.
Given the criticality of fill/finish processes, it is clear that automation is the next technological step.
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.
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.
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.
