Upstream Processing

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.

Simple methods can characterize polysaccharide vaccines and recombinant cytokines at high resolution.

Intact protein LC–MS detected a mass variance of 62 Da and peptide mapping located a difference of two amino acids.

Rolling-tube system balances scale-up accuracy and thoroughput.

Identify the best experimentation methods for the data you need.

The HMS174 strain, in the absence or presence of excess phosphate, can metabolize acetate efficiently.

An exponential feeding strategy coupled with automation doubled protein yields while reducing fermentation time by 25%.

Two case studies show how advanced information technologies make process development more efficient.

Wet testing of microbial fermenters allows for a greater understanding of the equipment's capabilities.

The quest for increased productivity and better process control combined with patient safety has encouraged biopharmaceutical companies to use chemically defined media for cell culture.