Friday, February 7, 2014

Highlights from the Flexible Facilities Podcast Featuring Adam Goldstein's podcast features Adam Goldstein, Principal Scientist, Global Manufacturing Sciences, Genentech.Goldstein discussed the implementation of single-use technologies for biotech, unit operations, and new applications. Check out our highlights below:

Single-use technologies show their benefit in the workplace for biotech. What are some of the biggest concerns for implementation?

Adam: Some of the biggest concerns are actually quite varied. While single-use technologies have been well adopted over the last several years, as they grow in their varied uses in upstream and downstream and now gaining dramatic popularity in drug products as far as disposable fill systems go, there are a couple of different issues or concerns for implementation – a couple that are well known, such as extractables and leachables. While we believe we have a good handle on extractables leachables, which many companies have their own program for determining what those acceptable limits or values may be and/or risk assessments are capable of managing, as we are continuing to use the disposables and unit operations, there are some surprising side effects of our findings that are directly from leachables – from the process.

What are some of the newer innovations you’ve seen coming out to the marketplace? 

Adam: Some of the newer innovations that I continue to see innovate that are particularly close to me in the work that I’m working on that I will probably review with you on the talk will be bulk freeze applications. So, there are a number of new applications coming out that are having end-to-end solutions from small scale, somewhere around 1 to 2 to 5 liter freezes up to 12, 16, 20 liter freezes and now up to 300 liter freezes in a disposable bulk-free system. Those innovations, while novel, also are not without their risks and we can review some of those risks as well, during the talk.

Download the full podcast.

Join Adam February 24-25 at IBC's 2nd annual Flexible Facilities. To learn more, download our brochure. Register with code FLEX14BLOG and save 20% off of the standard rate. We hope to see you in Berkeley, CA!

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