Upstream Processing

Development of the ideal DNA vaccine requires the optimization of delivery strategies and plasmid vectors.

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.

How to strike a balance between site autonomy and global coordination.

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

Cell concentrations and resulting protein concentrations are higher in a concentrated fed-batch process than in a standard fed-batch culture system.

A recent industry survey shows keen interest in improving bioreactors and cell-culture media.

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

An overview of applications in the analysis of nutrients and metabolites.

A plant-based expression system could provide greater speed and capacity at a comparatively low cost.

A hollow fiber matrix allows for efficient harvest of secreted proteins.

The authors discuss an alternative to traditional Protein A resins.

The authors developed a test for defects in filter membranes.

The authors examine several issues that will help streamline negotiations between a service provider and a cell-culture medium consumer.

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

The authors describe an industrialized process for the manufacture of iPSC-derived human cardiomyocytes.

Comparing the economic feasibility of a typical glycosylated protein.

A case study to compare the performances of several types of mixing in disposable bags with stainless steel bioreactors.

These new analytical methods can reduce analysis and product development time.

Use it label-free, or add labels to detect contaminants in solution.

How current economic conditions affect your build-or-buy decision.

Develop a relevant design space without full factorial DoE.

By providing information on the relative accessibility of locations within a protein, HDX by mass spectrometry opens new windows into the higher order structure of biomolecules.

Biomanufacturers should follow a risk-based approach to decide which methods to use to characterize their products.

Spectroscopic methods such as circular dichroism can detect subtle differences in higher order structure before and after changes in process and formulation.