Recombinant

New Factor VIII Product

Laurie Kelley August 4, 2008

It’s not too often that a new factor VIII product comes along. I don’t pitch products, but I do announce new products and developments to keep our readers educated and up to date. So you should know there is a new factor VIII product called “Xyntha.” It’s pronounced “ZIN tha” and it’s manufactured by Wyeth.

Why another recombinant factor VIII? This one will replace ReFacto, Wyeth’s only recombinant FVIII product. ReFacto is first-generation recombinant FVIII; Xyntha is third generation, and will be competing with Advate, the first third-generation FVIII product.

So in a nutshell, hemophilia A factor VIII concentrate users have:

PLASMA DERIVED
Alphanate (Grifols)
Monoclate-P (CSL Behring)
Koate DVI (Talecris)

RECOMBINANT
First generation
Recombinate (Baxter)

Second generation
Kogenate FS (Bayer)
Helixate FS (CSL Behring)

Third generation
Advate
Xyntha

Which is best? How do you choose? Questions about Xyntha? That you need to discuss with your doctor! Please remember to go see your HTC at least once a year for clinic, more if you are under age 18 or have any complications of hemophilia bleeds.

Book I Just Read: Untamed Seas by Deborah Scaling Kiley

I went sailing this weekend, and most of the trip was haunted by a foreboding thunderstorm that seemed to chase the chartered ship. As thunder cracked right over our heads and lightening split the sky, I thought about this book I had just read. Untamed Seas tells the amazing story of five people who tried to sail the Trashman, a yacht owned by a wealthy businessman, to Florida in the fall of 1982. They never got passed the northern east coast. Caught in a gale, the ship sank and there the remarkable story of survival begins. Who lives and who dies? This is a study in discipline, leadership, teamwork and crisis over a span of only 5 days. Hard to put down, you might finish this in one night yet the story will never leave you. And us? We made it back fine, back to Gloucester harbor, where the true story (As told in the excellent 2000 movie “The Perfect Storm,” starring George Clooney) of the sinking of the Andrea Gail begins and was filmed. Three out of four stars.

Tour of Bayer Plant

Laurie Kelley October 23, 2006


I escaped the chilly Boston weather for a few days to visit some community friends along with representatives of Bayer in Berkeley, California for Bayer’s new Multidisciplinary Board meeting. This is the second meeting we have held this year. An eight-hour plane ride brought me to beautiful San Francisco, surely one of America’s prettiest cities. I caught up with Mike Rosenthal, formerly executive director of the Hemophilia Association (Arizona), who is still active in the community. Later, at dinner, our colleagues included Dr. Craig Kessler (Georgetown University), who was just elected chair of NHF’s MASAC, Kyle Callahan, president of Hemophilia Health Services, Sandy Oliver, director of Public Policy and State Government Affairs at Bayer, Paul Bedard, director of Kogenate FS marketing and Terry Tenbrunsel, vice president of Bayer. We also enjoyed the company of Harp Maan, a young business student with hemophilia who had just finished Bayer’s first leadership program. This is a 10-week internship that exposes the participant to all aspects of working for a pharmaceutical company, from marketing to production to patient activities.

On Friday we spent the morning learning more about Bayer’s products and providing feedback about the community’s needs. In the afternoon, we had a fascinating tour of the production facilities. We learned how Kogenate FS is made. This involved gowning up, which requires wearing special garments and layer and layers of protective plastic material so we do not contaminate any aspect of production. We had an escort at all times who explained the process scientifically, and also made sure we did not violate any procedure that would cause contamination. From fermentation to purification to packaging, it was an impressive look at how recombinant factor concentrate is made. Accompanying me was Mike Rosenthal and Paula Hackenjos, Terry’s executive assistant. An employee of Bayer for 20 years, this was Paula’s first tour of the plant, and she and I joked that we felt like we were wearing our pajamas as we paraded by the scientific machinery, cold rooms, and sterilization equipment.

I was deeply impressed with the manufacturing process and how it is designed to provide safety at every level. The staff were knowledgeable and warm, and so enthusiastic about their work! And you would not believe the steps and procedures it takes just to make one vial of factor!

That night we all reconvened for a lovely dinner, where we all became better acquainted, while overlooking San Francisco’s vast bay, glittering with lights strung from the bridges and twinkling from passing boats. Dr. Glenn Pierce joined us. You may recall Glenn was NHF president two times, is a doctor, a person with hemophilia, and now is vice president of Preclinical Development at Bayer. He is also a personal friend of both my husband Kevin and mine. Thanks to Terry and Bayer for the gracious welcome, dinners and chance to tour the plant. We appreciate the forum for airing our comments and concerns, and to meet with some dear friends in the community

HemaBlog Archives
Categories