Downstream Processing

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.

Characterizing the higher order structure (HOS) of protein drugs increases manufacturers' understanding of stability and batch-to-batch variability, and may make it possible to link variants or aggregates to safety and efficacy. Yet at the January 24 CMC Strategy Forum in Washington, DC, regulators expressed concern that methods to characterize the three-dimensional structure of proteins are not routinely applied to biotechnology products.

Salt-tolerant adsorption and unique selectivity are the major advantages of mixed-mode materials over single-mode resins.

This alternative purification method to chromatography is readily scalable and fits a fully disposable downstream process.

To speed up the downstream process, you must get the right data, in the right amount, at the right time. Here's how.