Setting the Stage

Much has already been written lately about addressing the so-called “downstream bottleneck(s).” A number of companies are leading the way toward developing products and platforms for reducing both the costs and the time required for downstream processing. Our task with this special issue was to provide a state-of-the-art update on these activities — but as always, within a limited number of pages allotted.

The primary issue behind this bottleneck debacle is to address purification challenges posed by aggregation in cell culture supernatants after cells are pushed to high antibody titers. This special issue therefore touches upon trends in single-use purification options, single-stage and turn-key harvest solutions, and cutting-edge innovations in chromatography.

Knowing that our coverage would only scratch the surface of the work being done, I polled members of BPI’s editorial advisory board. I asked them what sorts of articles they want to see more of related to current trends in downstream processing. The following list summarizes their responses. If you (or a colleague) would like to explore writing about any of these subjects for us, I welcome your comments!

Addressing the Bottlenecks: Topics of Interest

Is the DSP capacity constraint real? (Two opposing views would be interesting.)

What are some real examples of process optimization and scale up, characterization studies, using two chromatography steps instead of three, economics of downstream processing, and the future of downstream processing?

What is the current interplay between process and facility design to facilitate manufacture of multiple products per manufacturing site to maximize facility use?

New nonchromatographic purification unit operations could change the current issues with chromatography (cost and throughput limitations) — what are some of these cutting-edge technologies?

What platforms are being developed for non-MAb products (microbial, oligos)?

Are there yet design space case studies that describe the entire downstream process?

What are people are doing to purify some of the new molecular entities such as antibody fragments?

What is the impact of PAT on DSP development and efficiency?

What benefits are possible from Lean/Six Sigma implementation?

What disposable technologies are available for DSP, including some of the new resins and disposable cassettes? Who are the new players in the “bag business?”

What is the latest information on storage of BDS (base-deactivated silica) columns at ultra low temperatures?

What are considerations for FMEA risk analysis for downstream processing?

These topics are to be addressed in upcoming issues of BPI, but only with your help — as always, our readers are our authors, those of you at the forefront of the 21^st century biotechnology industry. Let us know what you think!