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When a supplier switches

At the end of last year, The Scientist editors spotted a linkurl:warning notice;http://www.quantabio.com/bio-rad.php on the Quanta Biosciences Web site that their supply relationship with Bio-Rad had been terminated. In particular, certain PCR reagents that Quanta had been manufacturing for Bio-Rad were no longer the same and Bio-Rad was now making its own formulations. The key question is: Are the reagents any different? If so, how? The answer, so far, has proved elusive. I heard from severa

By | March 31, 2008

At the end of last year, The Scientist editors spotted a linkurl:warning notice;http://www.quantabio.com/bio-rad.php on the Quanta Biosciences Web site that their supply relationship with Bio-Rad had been terminated. In particular, certain PCR reagents that Quanta had been manufacturing for Bio-Rad were no longer the same and Bio-Rad was now making its own formulations. The key question is: Are the reagents any different? If so, how? The answer, so far, has proved elusive. I heard from several researchers, and Bio-Rad clients, that they had never been informed about the switch in reagent formulations until a sales rep from Quanta's new distributor had come to their lab and informed them. "I was shocked that [Bio-Rad] changed the formulations and never said anything," says Sherri Wood, an immunology lab manager at the University of Michigan, who learned of the switch in the fall of last year when a sales representative from VWR -- Quanta's new product distributor -- came by the lab. She hasn't noticed a change in any experimental results, but says it would be difficult to tell since they had redesigned their experiments recently, and many experimental factors have changed. But the new reagents could have potentially had an effect, she adds. (The price also dropped, from about $700 dollars in May, 2007, to about $500 in November.) Hardly a day goes by that William Geist, vice president of sales and marketing at Quanta Biosciences, says he doesn't get an email from a former client inquiring whether a change has been made to a reagent or requesting a sample. Since VWR began visiting laboratories and telling researchers of the switch, Geist has received dozens of sample request forms. But most clients still don't know about the switch, he says. I emailed Bio-Rad representative Ron Hutton to ask how the reagents had changed, and received an official statement that said: "We have made no changes in the performance and quality specifications of our PCR reagents." Hutton declined to tell me how many clients Bio-Rad supplies reagents to, or speculate on how many experiments may have been affected after the change was made. The company also refused to say which, if any, steps it took to inform clients of the change in reagents. Bio-Rad is one of the top five suppliers of PCR reagents. For four years, Quanta Biosciences produced the reagents for Bio-Rad, which sold the reagents and labeled them as "Bio-Rad iScript cDNA synthesis kit," or "iQ SYBR green supermix" for example. At the end of 2006, however, Bio-Rad ended the relationship with Quanta, and began making their own reagents. Quanta sent out Emails to some of Bio-Rad's biggest clients, and in some cases followed up with a phone call. But the labeling on the Bio-Rad containers remained the same, and the item ordering number stayed the same, says Geist. Randy Davis, manager of the lab facility that provides real time PCR to 100 investigators at the University of California, San Francisco, Cancer Center, says that a change in an enzyme could have a big impact on experiments. When he heard from colleagues that the reagents had been switched he started running tests to see how the two products compared. So far he has only tested the new Quanta reagents (he is not funded by either company.) "If I was Bio-Rad I might tell people my [reagent] had changed," he says. "I might do it in a way saying 'I like my new enzyme better, I'm dropping the old enzyme,' and provide some data." Quanta's Geist, for one, is saying that the reagents are different. The company is in the process of analyzing data from comparison tests of the new Bio-Rad and Quanta reagents, run by an independent company. Geist said in an Email that preliminary data show differences, but he declined to send me the data. Geist says he knows that some labs have left Bio-Rad and are now getting their reagents from Quanta, including the New York Department of Health. I called Katherine Zdeb, director in the office of education and outreach at the Wadsworth Center (one of research centers at the New York Department of Health), and she told me that they don't want their scientists to comment on products. I asked Geist for more examples of labs that had switched to Quanta because Bio-Rad's reagents do not work as well. He forwarded me an email that a research group in Northwestern had sent him last November, whose contact information he had blocked out, asking for a test sample of the Quanta reagents because they had noticed changes in their results. But Geist declined to provide a contact at the Northwestern group, and he said the researchers told him they did not want to comment. Hutton said that the decision to end the relationship with Quanta was part of Bio-Rad's plan to "consolidate and internalize our supplier relationships" on various products, reagents being one such product line. In its official statement, Bio-Rad said: "Our company interacts with thousands of suppliers on an annual basis. We constantly re-evaluate sources." So it remains unclear how the reagent formulations have changed, and whether the changes could affect users' experiments. Heard anything? Tell us -- anonymously, if you'd prefer -- by posting a linkurl:comment;http://www.the-scientist.com/forum/addcomment/54514/ to this blog, or sending an email to: mail@the-scientist.com.
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Comments

Avatar of: Li Chen

Li Chen

Posts: 10

March 31, 2008

Clearly, this might have a huge impact on PCR based diagnosis and/or risk assesment. At least, new calibration is required for sensitivity and specificity of the running test.
Avatar of: anonymous poster

anonymous poster

Posts: 2

March 31, 2008

For most researchers not connected with either Qiagen or BioRad, this question is outside the scope of their research programs, and addressing it openly would definitely not amuse their program sponsors. For others, the spectre of either Qiagen's or BioRad's lawyers digging into their results (and every other possible aspect of their work histories and laboratory environment) might loom as a nightmare-in-waiting. \n\nThe lab I worked in took on Sigma-Aldrich some years ago over a product problem, and we paid some serious freight unrelated to the facts of the case. I'd do it again today, but then, I'm still a romantic idealist after all these years. Good luck!
Avatar of: anonymous poster

anonymous poster

Posts: 1

April 7, 2008

customers about the switch unless customers asked outright. They did little validation and created the new formulations in a matter of a few months. Customers were slow to notice the change because Bio-Rad bought a six+ month supply of reagents to ease through the change. Bio-Rad rep claimed they had to end the relationship with Quanta when they finally licensed their PCR machines from ABI. Quanta has a excellent reputation for quality reagents, so the change was not made due to supplier issues.
Avatar of: Libby Yunger

Libby Yunger

Posts: 1

April 8, 2008

If the following three assumptions are correct:\n1) Quanta was producing the PCR reagents under contract to Bio-Rad and with a formulation and to specs set by Bio-Rad. \n2) When Bio-Rad changed the location of production of their branded reagent from Quanta to their own facility, they were using the same formulation and the same specs that Quanta had used - only the place of manufacture changed. \n3) Bio-Rad has QC data showing that the product made at Quanta and the product made at Bio-Rad are identical in composition and performance.\nthen it is probably not necessary to inform customers of the change in manufacturing location. Under these circumstances a change in the formulation would only have occurred if Quanta was adding something to the formulation that was not specified by (and therefore, unknown to) Bio-Rad. Contract labs lose contracts all the time - Quanta should get over it.\n\nOn the other hand, if Bio-Rad did change the formulation as well as the manufacturing facility, they really must inform those customers who have validated the Bio-Rad product for laboratory or manufacturing use so that the product can be revalidated.
Avatar of: anonymous poster

anonymous poster

Posts: 1

April 9, 2008

As someone who WAS a loyal Bio-Rad user, I can address the assumptions made by Libby.\n\nSome Background: Our group used Bio-Rad's iScript and iQ SYBR reagents beginning in 2003. \n\n1. Bio-Rad does NOT know the formulations. According to Quanta's literature, they did not share the formulations with Bio-Rad. When I heard about the change through my VWR rep I asked the Bio-Rad rep about this and he confirmed that the formulatios had changed. Prior to this we had noticed slightly different results in our SYBR kit performance that we could not explain. The new formulation worked but it was different. The iScript kit was fine (we eventually confirmed with the lot number that this was still Quanta's formulation).\n\nOur group no longer trusts Bio-Rad because they made no attempt to inform us of the change. They risked compromising our experiemental results. \n\nWe now purchase Quanta's "Bio-Rad" formulations through VWR.\n\n2. Bio-Rad changed the formulations AND the location of production. We got the "new" SYBR formulation last fall. So the change occured around then. \n\n3. The formlations are different. Showing a QC spec with a few genes is not really convincing. We have evaluated a lot of kits and while most "work", the results are rarely "identical"...and they shouldn't be because they are all different formulations!\n\nOn your last point, you are correct.
Avatar of: anonymous poster

anonymous poster

Posts: 1

June 18, 2008

Our lab used the SyBR Green Supermix from Applied Biosystems but I recently received new product samples from Quanta and BioRAD and I tested these three SyBR Green Supermix. The SyBR Quanta is the most sensitive but the least specific (easiest to make primer dimers); the Applied SyBR is the least sensitive and with an occasional non-specificity; the BioRAD's iTaq SyBR (not iQ, I suppose the iTaq is a newer product) gives the same sensibility than Quanta for more than 100 copies in the well, it failed to detect 10 copies per well (but I used a fragment I diluted one year ago and conserved at -20C so I dont exclude the degradation factor) but not a single primer dimer observed, the baseline is as low as Applied (Quanta gives very high base line), but it gives the Ct as early as Quanta (even sligtly earlier) for more than 100 copies per well. So if we have a perfect pair of primers, the Quanta's SyBR is a good choice, but if we have many genes to test and for some of them we have not a perfect pair of primers but functions perfectly with the BioRAD's SyBR, I can't choose the Quanta's SyBR Green. One more detail, the Quanta's enzyme is active during longer time than the BioRAD's enzyme (the Applied's one the least). If we consider the final quantity of amplied fragment, we can choose Quanta. I was ready to purchase the BioRAD's iTaq SyBR before I read this blog. I trust my result, I believe that the BioRAD's SyBR Green I tested is my best choice but if they dont inform changes in their products I'll be afraid.

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Mettler Toledo
BD Biosciences
BD Biosciences