From the Editor May 2011

BPI Contributor

May 1, 2011

2 Min Read

Bonjour! I am writing this from Nice, France, on the last day of the eighth annual BPI European Conference and Exhibition organized by our London-based Informa Life Sciences colleagues. Despite the attraction of some exquisite spring weather (a welcome respite for me from the rain-drenched Pacific Northwest), sessions were well attended till the very end, and discussions were lively and productive.

This event was organized into five tracks: manufacturing strategies, process optimization, economics and QbD; cell culture and upstream processing; recovery and purification; formulation strategies, aggregates, subvisible particles; and analytical methods, ADCs, prefilled syringes, and PAT. It has been impossible for me to cover it all, but I hope I can share many of these presentations with you as technical papers.

Along with the chance to meet new people, this is one event each year that helps me stay up to date on issues affecting the European regulatory environment. It is natural for people to spend more time in their individual comfort zones than is necessarily wise, so I welcome the complementary perspectives and the challenge to bring this information into the magazine. Please let me know what you would like to learn specific to evolving harmonized regulations — and if you have recent experience seeking product approval in Europe, consider writing for us!

Another element of the US and European BPI Conferences is a Best Poster award. Winning posters are announced in the magazine, and the authors receive complimentary placement in our annual Poster Hall supplement. If you haven’t had a chance yet to view the posters from this past November’s supplement, go to for the online experience.

This week, members of the conference advisory board and I selected two winning posters: one from a supplier and one from an end-user. The supplier poster we honor this year is from Masahiro Funaki and Kazunobu Minakuchi of Kaneka Corporation with offices in Brussels, Osaka, and New York City. Titled “Protein A Cellulose: A New MAb Purification Platform,” it reports on Kaneka’s use of alkaline-resistant genetically engineered Protein A ligands in developing MAb capture media based on highly crosslinked cellulose.

The winner of the end-user poster is a team of authors from Sanofi-Pasteur. Virginie Fabre and colleagues presented “When Downstream Process Is Able to Withstand Upstream Changes: An Example of Clarification Sequence Optimization in Viral Vaccine Production.” This is not only a timely topic given renewed interest in vaccine development, but the poster was designed around clearly presented examples.

Our thanks to all those who presented posters and/or spoke at this year’s event in Nice. And I congratulate our UK colleagues for having offered such an excellent program once again. Please plan to join them next year (18–19 April 2012) at the Clarion Congress Hotel Prague as BPI Europe returns to the Czech Republic.

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