Downstream Processing

The author describes recent developments to help overcome the downstream-processing bottleneck.

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

Reliably detecting low amounts of high molecular weight impurities during process development and characterization of biopharmaceutical products.

Insights from real-time ranking of global biomanufacturing capabilities.

The authors present a case study identifying a contaminant.

The authors discuss an alternative to traditional Protein A resins.

Rapid microbial screening provided by contract laboratories can save companies time and money.

The authors outline qualification procedures for a process-critical piece of equipment.

Newer classes of biotherapies will require innovations in processing technology.

A high-performance anion exchange resin performs well compared with membranes. In addition, the resin offers greater flexibility and cost savings.

This summary provides an introduction to our special issue on Separation and Purification.

Careful analysis of an unusual precipitate identifies defects.

The authors developed a test for defects in filter membranes.

Making chemically defined media work.

Release testing involves both standard potency assays and unique assays (particle size, NA activity) developed to ensure the physical, chemical, and biological stability of this type of vaccine.

Adjuvant activity can be greatly improved by appropriate formulation of cytosine-phosphorothioate-guanine oligodeoxynucleotides (CpG ODNs).

Filterability and bacterial retention must be verified very early in process development to ensure successful sterilizing filtration validation.

Adjuvant activity can be greatly improved by appropriate formulation of cytosine-phosphorothioate-guanine oligodeoxynucleotides (CpG ODNs).

Can vendor-user partnerships overcome the typical wait-and-see attitude toward new technologies?

Develop a relevant design space without full factorial DoE.

Although single-use systems are widely used in upstream unit operations, their acceptance in downstream processes has been slow.

An analysis of flow rate, load density, viral clearance, and cost.

How to balance porosity, plugging, and lot-to-lot variability in filters.

Biomanufacturers and vendors are now exploring more cost-effective purification technologies.

We all know that experience is the best teacher. With H1N1, we have a great opportunity to learn important lessons.

How to use risk assessment strategies to integrate operations.

A systematic approach facilitates formulation component selection.

HTPD allows rapid screening of chromatographic parameters.