Extractables and Leachables: Standardizing Approaches to Manage the Risk [eBook]

15-3-March-eBookThe implementation, maturation, and benefits of single-use technologies in biopharmaceutical development and manufacturing are well documented and understood. As analytical methods and testing services also rapidly improve, it is clear that management of risk associated with extractables and leachables also must evolve. Standardization is universally accepted as a goal; how to define, implement, and educate the industry is where debate resides.

The container–closure segment has had more experience dealing with leachables and extractables than those implementing single-use process components do — they’ve just been doing it longer. BPI takes a closer look at relevant guidance and regulations and examines how groups such as BPSA, ELSIE, ISO, and USP are helping users make sense of it all.

This eBook reviews the industry’s approach to leachables and extractables to address an underlying question: How close are we to making standardization a reality?

Read an excerpt from the eBook below:

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What are the current challenges in Bioprocessing?

Here at the Bioprocessing International European Summit, we asked a number of leading industry experts from across all sectors of the industry what are the biggest challenges they are currently facing in their work, and what is being done to resolve and overcome these challenges.

Parrish Galliher, Chief Technology Officer for Upstream, GE Healthcare outlines his thoughts on current challenges.

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LISTEN: Melema Single-Use Mass Flow Meter

In the latest product podcast, Alan Young, CTO of Malema Sensors in California takes you through their family of single use flow meters, and for anyone who is using a flow meter right now or may need one, I think you’ll find this very interesting.

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Bringing it all Together for Commercialisation Pt.2

Brian Caine, co-founder and publisher of Bioprocess International Magazine sets out the topic of discussion for the fireside chat, “Bringing it all Together for Commercialisation – perspectives from every stage” and introduces the panel of experts, with conservatively over 100 years of experience between them,

Opening the discussion, Brian explores the problem of cost and time inefficiencies currently causing the industry pain.

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The Story of BPI Europe 2016 in Photos

The BioProcess International European Summit 2016 took place in Vienna last week. We’ve gathered together some of the best photos from the conference; if you were there, this is your chance to relive it; if you weren’t, then see what you missed.

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WATCH: Highlights from BPI Europe 2016

After a fantastic week in Vienna, we’re back from this year’s BioProcess International Europe. A very big thank you to everyone who attended; it was great seeing so many familiar faces, as well as meeting lots of new ones. Try and spot yourself in the highlights video above, or if you couldn’t make it, see what you missed out on and hopefully we’ll see you next year.

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Vienna Area Guide: Restaurants & Points of Interest Near BioProcess International European Summit

With less than a week until the BioProcess International European Summit in Vienna, we have put together a handy guide to the restaurants, places of interest and taxis in the area. We hope you find these recommendations useful during your time spent in the city.

Casual Restaurants


Wohlmutstrasse 23, Vienna 1020
Phone Number: 676 35 95 174

This restaurant can be found just 500m from the conference venue, and can be walked in 6 minutes. The Wohlmutstueberl “combines traditional Viennese cuisine with delicacies for the health conscious” and has an extensive a la carte menu that can be viewed here.

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