Where has that antibody really come from?

The definition of OEM (Other External Manufacturer or Original Equipment Manufacturer) is ‘when one company makes a part or subsystem that is used in another company’s end product’. Essentially this means that the manufacturer sells its product to another company to help build another product, such as the use of Bosch fuel injectors in a Ford car. This happens all over the place from the automotive industry to the antibody industry.

The reseller may sign a license agreement with the manufacturer so that it can take the product in-house and produce more of it, or the manufacturer may continue to be the only producer and sell to the reseller at a discount. It is this second option that has become a more significant factor in the research antibody industry.
 
Initially, antibody firms would create all of their antibodies in-house, or pay huge sums of money to sign license agreements with researchers in academic labs. But somewhere along the way bright biotech entrepreneurs began to realise that they didn’t have to invest in manufacturing, as someone else could do all the hard work for them. Instead, they agree a discounted price with the manufacturer and relabel the antibody as their own product. This practice has now permeated the industry.
 
And hey presto! Today we have over 300 antibody vendors of whom some only manufacture and sell their own products, some only buy in other company’s products and others that do a little bit of both. Of course, none of these companies are doing anything at all wrong, in fact they may even be making your life easier – with proteins coded by 17,294 genes often it is easier just to buy from a single store, much like at Amazon.
 
A recent sweep of the Biocompare antibody catalogue by Jan Voskuil of Everest Biotech showed some interesting insights into the commercial antibody world of OEM. As he explained at the recent 1st International Antibody Validation Forum searching the Biocompare online catalogue for antibodies to the stem cell marker OCT4 returned 582 listings from 41 different vendors. When he looked at these different listings further, through examining their product sheets and the data associated with them, he found that only 30 different antibodies were actually listed, the rest were repeats of each of these listings. The same thing with antibodies to the transcription factor FOXP3, where 1055 antibody listings in the catalogue from 47 different vendors, on closer inspection were revealed to be just 31 different antibodies.
 
The way this situation occurs is that an antibody made by company x can be sold at a low cost to company y to put in their catalogue. Company z may then come along and buy the catalogues from company x and y. Instantly, we have a situation where 4 antibodies are listed on a site like Biocompare when in actual fact only one antibody exists, but is available through different vendors.
 
As a consumer you would think this may lead to better pricing and increased competitiveness, but there isn’t much evidence of that. What it does cause is much confusion (link is external). Confusion in buying antibodies and confusion in using antibodies. When buying antibodies you have to make sure that any you may want to trial are actually different and not just differently labelled versions of the same thing all coming from the same manufacturer. This can be done through comparing the antigen used and the antibody formulation. Though different vendors may sell the same antibody
 
Confusion in using the antibody is a different matter. When a vendor buys in antibody products to sell as their own, they are not required to use the original QC data. Many generate data in-house or obtain data from their customers to make the antibody look different from the original sold by the manufacturer. The same antibody can now be seen on different catalogues with different data associated with it.
 
A problem arises when the original batch of antibody being sold by the manufacturer runs out. Batch-to-batch variation can be significant with polyclonal antibodies and though not to the same extent, natural drift in hybridomas means that this variation exists for monoclonal antibodies too. The manufacturer may issue new data with the new batch of antibody, but if the antibody is a good seller not all vendors will be keen to change the associated product sheet. This lack of transparency could lead to scientists purchasing antibodies that are not correctly listed on their product sheet and that no longer function at the listed concentrations or in the specified applications. Antibodies that may once have worked fine in the researchers hands, but now inexplicably seem to fail.
 
Avacta Life Sciences are the only manufacturer of Affimer reagents and biotherapeutics, so our customers can rest assured on consistent, high quality products.