To find out more about the deal and the FDA’s approach to microbiology, we spoke to Foster Jordan, corporate senior vice president of CRL’s EMD business.
Contract Pharma: What services are you gaining through the Accugenix purchase, and how do they complement CRL’s existing portfolio?
Foster Jordan: My business unit provides products and services used at the tail-end of the drug development cycle, once the product is approved by FDA. Microbial and endotoxin testing is required on all raw materials, in-process samples and finished product as part of the manufacturing activity in pharma, device and dialysis companies. Our primary business today focuses on the endotoxin testing.
We are the market leader in that type of test. Endotoxin is really nothing but the dead cell wall of a Gram-negative bacteria, like E.coli or salmonella, that’s been destroyed either by chemicals or sterilization in the process. The cell wall is still toxic to people if it is injected.
The other major part of quality control from a microbial standpoint is the total viable organism count and identification. Most samples tested for endotoxin are also tested for viable organisms: bacteria and fungi.
If there is an over-the-limit detection of microorganisms in the manufacturing process, the FDA requires that you identify the organism and try to understand where it came from, in order to prevent it from happening again. And this is where Accugenix comes in. They can provide a very accurate identification of those organisms.
So we offer a full range of endotoxin testing products to our customers but they also conduct microbiological testing on those same samples. If the sample comes up positive for microorganism, then Accugenix can perform the bacterial ID. So it is the same customer, the same lab usually, and in many cases the same sample.
CP: How much overlap is there between CRL’s customers and Accugenix’s?
FJ: There is approximately 80% customer overlap. However, we have a much broader existing customer base in dialysis, nuclear pharmacy, and compounding pharmacy. Those areas require similar type of bacterial identification services as pharma, so we will be able to offer this service to them.
CP: How are you looking to integrate Accugenix into CRL’s EMD business?
FJ: Our goal is to offer clients a total solution to a company’s rapid endotoxin, microbial enumeration and identification program including: instruments, consumables, software and outsourced services. To support this goal, we have the same sales organization, the same field support service, and similar customer accounts. Ultimately, we’ll be adding other products to this same area.
CP: Was Accugenix looking at bidders, or was this a case of CRL aggressively looking to expand?
FJ: We are actively looking in the M&A area, for companies that could be attractive additions to our portfolio. We also have a list of services and products that we are developing internally, as well, to compliment our acquisitions.
Accugenix is a great move for us. It is recognized as the gold standard for bacterial identification in the pharma space. Our customers are very happy with this acquisition. Together, we are much stronger than we were apart. It’s a perfect platform to integrate the other solutions we are looking for in the rapid microbial space.
CP: How has the microbial testing field changed in recent years?
FJ: The biggest change, which affects everyone in pharmaceutical manufacturing, is the FDA’s focus on CAPA, corrective action and preventative action. The FDA wants companies to aggressively determine the root cause of the failure and aggressively fix the issue before manufacturing.
In the old days, if you made a batch and QC failed, you just went in and made another batch. Today, the FDA requires companies to understand the root cause, implement corrective action in a timely manner, and ensure that the problem is resolved.
So when you look at bacterial identification services, one of the reasons it is so important is that you can’t address the issue if you don’t know the organism. If it’s a Gram-positive organism, it is probably it was introduced to the product through your people. If it’s a Gram-negative organism, it is probably it came through your water system. That type of identification is very important in order to identify root cause of the contamination.
CP: What do you think has led FDA to get more strict about this?
FJ: The agency realizes that statistical sampling of your finished product is not a 100% solution. Under that model, companies can only test a certain number of samples of final product. For example, if you make 15,000 vials, you’ll sample some, but this model leaves room for error. The FDA wants companies to implement in-process controls, methods validation, and a CAPA system, to ensure a high quality final product.