An Apology from FTI

Posted on May 8th, 2008 by Marv

Dear Reader:

On Wednesday, May 7th our company inadvertently launched a series of e-mail messages to a mailing list for our Technical Newsletter. I apologize for this transgression of our business relationship, in the knowledge that each and every one of you was inconvenienced in some way by this mistake. Both as an organization and as individuals we are embarrassed by this incident.

While the problem is now solved, please be assured that we are taking steps to ensure that this cannot happen again. First, we will remove all names and e-mail addresses that requested to be unsubscribed. We realize that some of you may have only been “following instructions” to unsubscribe and still wish to be in contact with FTI, but we feel the only correct thing to do in this situation is to err on the side of caution. Secondly, we plan to migrate in the near future to a new mail server that has additional security features, again with the express goal of ensuring the events of yesterday cannot be repeated. I am giving you my personal assurance that this will not happen again.

In the end, your opinion of our company is more important to me and my colleagues than the business we may or may not do together. We will work to regain your respect and trust, as it obviously may no longer be assumed. If you would like to share additional thoughts or concerns (or vitriol), we have set up a special e-mail address for you to use: feedback@fluorous.com. I assure you that each and every message has and will be read by me, and that if you request a response, you will receive a personalized one.

Humbly Yours,

Philip E. Yeske
President & CEO
Fluorous Technologies, Inc.

Fluorous Technologies QC: Problem Resolution

Posted on May 7th, 2008 by Jeff

This post is the last in a series that details our internal quality control processes. You can also read the first and second posts.

In Case of Error

Despite our efforts and protocols, mistakes are occasionally made. We appreciate being contacted when reactions do not work as planned and are glad to help. We stand behind our products and will work to meet your high expectations for quality. Here are some of the things that we will do when you contact us about a problem with one of our products.

We’ll first try to determine if we sent the correct product by checking the documentation created during production and order fulfillment. Did the purchase order list the desired product? Does the label on the bottle match the PO? Are the supporting documents correct? Did we send the correct quantity?

If you have obtained some analytical data then we’ll compare it to our Record of Analysis (or provide you with the Record). We’ll also re-analyze the lot if it’s still in stock. We can also run a test reaction or F-SPE to make sure that there’s not some unidentified problem that our analytical techniques are missing.

Replacement material can be quickly sent if it’s in stock, and the original problematic material can be returned to us at our cost if necessary. In general our response to customers is to assume that we made an error, to identify the error, and to correct that error. The next step, or course, is to try and put in place a process that will prevent that error from reoccurring.

If it seems like the problem is not related to any error on our part, but arose due to the chemistry involved, then we’re more than willing to help improve on your fluorous approach. We’re happy to enter into a confidentiality agreement if that makes it easier for you to disclose the exact nature of the problem.

As you have seen in the last three posts, we have a number of procedures in place designed to ensure that the “Lucky Bonus Pack” that Derek wrote about in his blog doesn’t happen. As a company, we’ve gotten much better at QC then when we first started about 5 years ago. Back then we would get an order, make it, and ship it. Not much more than that. Now we check, review, and document every step of the way and have dramatically cut our incident rate. We’re proud of that and hope that by learning more about our processes that you will have greater confidence when you order from us.

Fluorous Technologies QC: During Order Fulfillment

Posted on May 6th, 2008 by Jeff

This post is the second in a series that details our internal quality control processes. You can also read the first post and the last post.

During Order Fulfillment

When an order for an in-stock material is entered into our fulfillment system, the appropriate product bottle is pulled from our inventory and an order fulfillment checklist is followed. A chemist reviews the bottle and the purchase order to ensure that the proper material, name and product #, is being packaged and that the lot # and bottle barcode are recorded. The chemist also ensures that a Record of Analysis is on hand for that lot. The chemist informally checks the material to determine if it has degraded since it was last analyzed. This is typically a visual check, though it can involve additional instrumental analysis at the discretion of the reviewing chemist. If the ordered product is a chemical that we know can degrade, then we will re-analyze it prior to shipping. Once deemed ok, the reviewer initials our order fulfillment checklist.

A second person is involved in the bottling and packaging of the product. Their responsibilities include:

  • Ensuring that the details from the invoice (product number, quantity, etc.) match the bottle to be delivered
  • Proper labeling of the bottle, including product number, name, lot # and quantity
  • Including the correct MSDS with the order
  • Addressing any specific additional customer requirements
  • Preparing all shipping documents and labels
  • Generally acting as a “second pair of eyes”

Once these duties are completed, the order fulfillment checklist is initialed and the bottle is boxed for pick-up. The order fulfillment checklist is then stored with a copy of the purchase order, so that if any problems arise we can quickly retrieve the order history and resolve problems quickly.

As in the case of producing the material itself, a key element of this process is to make sure that two people are involved in the order fulfillment thereby reducing the chances of an error occurring.

Fluorous Technologies QC: During Production

Posted on May 5th, 2008 by Jeff

Derek Lowe’s recent post “The Lucky Bonus Pack“, in which he talks about receiving a bottle that does not contain the right material, prompted some discussion here at Fluorous Technologies. We’re chemists, too, and we hate it just as much as the next chemist when this happens. We’re also a chemical supplier. So in a series of posts, I’d like to detail some of the Quality Control processes that we use.

During Production

All of our products are analyzed for identification and purity. This usually means obtaining an 1H NMR spectra and GC chromatogram and comparing them to the reference data for the product. Occasionally, we’ll also take an LC-MS, 13C NMR, or FT-IR.

For products that we market as Scavengers or Reagents, we also check for non-fluorous impurities. This involves passing the product through a FluoroFlash F-SPE cartridge using our standard F-SPE conditions and analyzing the non-fluorous wash by 1H NMR with an internal standard for quantification purposes. The required standard is <1 mol% non-fluorous impurities.

Once we’re satisfied that we’ve made the right product, the batch is clearly labeled with the part number, structure, lot number and unique barcode. A Record of Analysis for the lot is created, listing the tests performed and the results of the test. All supporting data for the batch are attached to the Record of Analysis and are reviewed by a chemist not involved in the synthesis. The Record of Analysis is signed by both the issuing and reviewing chemists. Only when this is done is the material released for sale.

Copies of the Records of Analysis are always available to customers upon request.

The guiding philosphy during all this is that we have a process with some redundancies in place which will help ensure quality. Two analytical tests and two sets of eyes reviewing the data. In addition, by having the Records of Analysis available there is a built-in accountability should something go wrong.

Fluorous Proteomics

Posted on April 30th, 2008 by Marv

Back in 2005, Eric Peters and co-workers from the Genomics Institute of the Novartis Research Foundation (GNF) published the seminal paper on the use of fluorous tags in proteomics. There they described their work in using fluorous tags to enrich samples for specific peptide subsets. The proteins that these peptides originated from could then be ID’ed by peptide mass fingerprinting using MS/MS and standard programs such as MASCOT or SEQUEST. Since that time FTI and GNF have been working to refine the labeling and separation protocols and to expand the number of applications using fluorous tags.

For those not familiar with proteomics, here’s a little background. Proteomics is the study of the “product” of the genome, that is the proteins that are expressed by the genome. I’ll make the imperfect analogy of a supermarket. The genome would be all the ingredients in order listed on every product in that supermarket. The proteome would then be all products. As you can see there are a lot more products than there would be ingredients, due to the various sizes, brands, quantities, etc. of each product. The problem when studying the proteome, therefore, is often one of complexity. Estimates seem to bounce around, but once you take into account not only all the proteins the genome codes, but also all the post-translational modifications, you may be talking about 500,000 different compounds. Some sort of sample simplification, therefore, is usually needed to make things more manageable. Luckily there are a number of ways to do this. For example, if you digest all the proteins to peptides, then tag the cysteine containing peptides, and analyze them, you can still identify the proteins they originated from but have reduced the complexity of the sample by about 1.5 orders of magnitude. To carry the supermarket analogy a little further, it would be like clipping and scanning all the UPC codes and associating them with a product instead of trying to note every box in the store.

Methods to conduct this enrichment include affinity tags, with biotin or His tags being favorites. Biotin and it’s affinity partner, streptavidin, are probably still the gold standard, but there are problems, notably non-specific binding to streptavidin and getting the darn tagged molecules off the streptavidin. What Eric Peters’ group did was substitute the affinity tag with a fluorous tag then used a fluorous solid phase extraction to separate the non-tagged peptides from the tagged peptides. The fluorous tag has some nice advantages over other methods including low non-specific binding, ease of separation, and a mass defect. The last one is interesting since fluorine has a mass slightly below 19. Since C, H, N, O, and S all have masses slightly above the whole #, one can easily tell if a peptide is fluorous tagged using this mass defect.

Functionally, the fluorous tag is similar to an affinity tag. So much in fact that the Peters’ paper calls it “fluorous affinity”. That, however, is a misnomer since there is no affinity between fluorous groups. The separation is partitioning based which allows one to do things that you could not do with affinity tags. For example, they demonstrated that you could separate doubly tagged peptides from singly tagged peptides and they have also shown that you can separate peptide subsets with different length fluorous tags.

Sounds great, huh? So why hasn’t it taken off more? Well, there are some issues which need to be sorted out, such as labeling efficiency. FTI has secured an SBIR grant and in collaboration with GNF we are working on these issues and expanding into quantitative proteomics. At this point, we are closing in on a protocol that should be robust, simple, and above all, kit-able. We’ll keep you informed.