Downstream Column

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The Downstream Column is a blog and community for scientists and others involved in downstream biomanufacturing. It is a place to share expertise and best practices as well as discuss topics of interest to the community. The blog covers purification, formulation, fill/finish and QA/QC of biologics manufacturing.

Associated Content

Downstream Manufacturing of Gene Therapy Vectors

In summary, there is an increasing range of options to process and obtain high titers and high-quality batches of viral vectors. These new developments, particularly in the chromatography approaches, have improved downstream process options, which have in turn enabled gene therapy. There are much needed improvements, especially in the areas of upscaling and lowering cost. Nevertheless, the industry is advancing, and the future is open to new innovations and capabilities....Continued

FDA CDER Novel Biologic Drug Approvals 2016

The FDA released its report titled “Novel New Drugs 2016 Summary,” in which they discuss 2016 FDA new drug approvals. In 2016, the FDA’s Center for Drug Evaluation and Research (CDER) approved 22 novel new medicines. The number of approvals in 2016 was down from 2015 with 45 approvals and down from 2014 with 41 approvals. In fact, in looking at approvals over the past five years, 2016 had the lowest number of approvals overall, however the number of new drug filings remained consistent....Continued

Continuous Processing Optimization with Smarter Tools

While skepticism exists, the automation solutions available offer unique and innovative ways to overcome the platform’s biggest challenges, much as cruise control and auto parking have enabled for drivers of cars. Doing so requires not just knowledge but also the willingness to push the boundaries of modern technology to improve patient care. Innovative bio-pharmaceutical companies are already leading the way in this arena, as significant advances in bio-production efficiency are expected over the next three to five years....Continued

Utilizing UVC LEDs in Biotech and Pharma – Paving the way to better instrument design and better manufacturing methods

UVC LEDs are also increasing reliability in biotech processing as well as process monitoring in pharmaceuticals. UVC LEDs enable longer instrument life, higher reliability, and increased productivity while reducing overall costs for the end user. These new devices are driving innovations in instrument design for the life sciences to address key market trends around productivity, cost reduction, and miniaturization....Continued

Biomanufacturing Innovations are Plentiful at This Year’s BPI Conference

Every time I attend a big conference like BPI, one of my favorite things to do is wander the Exhibit Hall to see what companies are working on and what innovations are being developed to improve various aspects of biomanufacturing. This year’s BPI was no exception and featured many new and interesting products and services for biomanufacturing. I plan to cover as many as I can with this and upcoming blogs, but this is by no means an exhaustive representation. Please feel free to add additional innovations in the comments section....Continued

3D cell culture set for space HD

3D cell culture developed by Professor Stefan Przyborski from Durham University using funding from BBSRC is scheduled to journey to the International Space Station in late 2014....Continued

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