Upstream Processing

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.

Method for integration of transgenes.

How to produce Plasmid DNA in a high-cell-density culture.

Through metabolomics, the metabolic underpinnings of cellular changes can be rapidly pinpointed, directing process development scientists to key areas for cell culture optimization.

By considering stability as part of the cell line selection and cell banking paradigm, we can ensure that instability problems are not observed during clinical or commercial manufacturing.

ACF medium sped up cell-line development.

Microbial systems such as E. Coli and yeasts are most effective for producing antibody fragments.

A prove-free system monitors accurately at very small scale.

New expression systems compete for attention.

With all of the new expressions systems being developed, companies must decide what improved production and yield are really worth.

What will it take for the industry to embrace new hosts?

Are disposable bioreactors effective for cell culture?

Understanding the relationship between the process and CQAs.

No time for QbD? How to convince management to make it a priority.

Using multivariate experiments to define acceptable ranges.

There could be a serious glut of commercial scale mammalian cell culture capacity over the next five years. Then again, there could be a significant shortage. It all depends on how things develop in expression technology, the new product pipeline, and corporate strategies.

A centralized quality control strategy may be the best solution.

There are a number of specific characteristics to be considered when developing and manufacturing live bacterial vaccines.

The year 2007 witnessed the approval of fifteen biopharmaceuticals in the United States and European Union.

Avoid manufacturing failures by effective viral inactivation.

To achieve the right balance between disposable and reuseable options, companies must consider important technical and economic factors.

There are several challenges associated with protecting patents for personalized medicines.

How to implement a risk-based approach to eliminating viruses.

A review of some recent contributions in process chromatography.

A discussion of past achievements and future expectations of recombinant protein production yields from mammalian cells.