Upstream Processing

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.

Plant-derived hydrolysates can be used as valuable and practical tools to improve cell culture performance.

Computational fluid dynamics can resolve performance problems.

Computational fluid dynamics is a powerful tool to optimize processes.

Gaining a license can be a complex process, but a few key tips can help you avoid common pitfalls and patent infringements.

How to reduce plasmid-mediated metabolic burden for higher yields.

Automated in-line dilution can help solve capacity, financial, and quality concerns that biopharmaceutical manufacturing plants may be facing.

To assess current trends in fermentation and cell culture equipment, BioPharm International turned to Geoff Hodge, managing director of process technology, Xcellerex, Inc.; Günter Jagschies, senior director of strategic customer relations, life sciences, biotechnologies, GE Healthcare; and Rich Mirro, product manager, New Brunswick Scientific.

To select the right partner for media design and optimization services, several key factors must be considered.

Select the best approach to determine critical quality attributes.

Companies often wait for a critical mass before adopting new technologies. But if no one takes the risk, critical mass will never be reached.