Charles River Labs recently acquired Celsis International for $212 million, expanding its Endotoxin and Microbial Detection (EMD) position with rapid endotoxin testing and bacterial identification systems for biopharmaceutical manufacturing.

Celsis provides rapid bacterial detection systems for quality control testing that are principally used for product-release testing to help ensure the safe manufacture of drugs and consumer products. The comprehensive EMD and Celsis portfolio is expected to drive increased adoption of EMD’s quality control testing solutions across both sterile and non-sterile applications.
  
Contract Pharma discusses the strategy behind the acquisition and the increasingly important area of quality control testing with Foster T. Jordan, corporate senior vice president, endotoxin and microbial detection, Charles River Laboratories. –KB

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Contract Pharma: What was the strategy behind the Celsis acquisition?
Foster T. Jordan: Our strategic plan is to establish the most comprehensive set of rapid quality control testing solutions in our core pharmaceutical market as well as the adjacent non-sterile consumer care industries. The Celsis acquisition is a significant milestone in achieving our goal, in addition to doubling our current market opportunity.

CP: What’s the gap that Celsis helps Charles River fill?
FJ: Celsis is a leading provider of rapid microbial testing systems for both non-sterile and sterile applications, making it an excellent fit with our existing EMD business. EMD provides endotoxin testing and microbial identification solutions for biopharma activities. In 2014, we introduced PTS-Micro for rapid bioburden testing, which is complementary technology to that of Celsis, and established our initial presence in rapid microbial testing.

We’re seeing that for both sterile and non-sterile applications, rapid testing methods are replacing traditional methods because they reduce risk, cost and time. Together, we believe EMD and Celsis will provide one of the most comprehensive solutions for rapid QC testing available, not only to the biopharma industry but also the consumer products industry.

CP: On the flip side, what benefits does the Celsis team see from this acquisition, besides the obvious? 
FJ: The Celsis team is extremely excited about becoming part of the Charles River EMD family. Not only does this give them access to our vast global distribution network, but also allows them to provide their customers a full portfolio of endotoxin and bacterial ID testing products and services.

CP: Had you done any projects with them previously?
FJ: No, we had not.

CP: Quality has been a hot topic with respect to drug shortages. What have you seen with respect to services in this area?
FJ: Drug shortages arise as a result of many factors. Quality issues related to sterility (such as bacterial or fungal contamination or the presence of foreign particles) are one of them and when this problem occurs it can slow down manufacturing and distribution of the product.

To mitigate these problems, manufacturers of biopharmaceuticals have been shifting the safety testing location for biologics raw materials away from the lab and to the manufacturing floor. Controlling the quality of raw materials used in cell culture-based biotech manufacturing processes is a complex process that needs to be measured consistently. Biologics also have a much higher value than small-molecule drugs; shifting to the manufacturing floor allows you to obtain quicker results.

CP: What range of services will the combined company offer?
FJ: The acquisition complements Charles River EMD’s offerings of rapid endotoxin testing and bacterial identification for biopharmaceutical manufacturing. The addition of Celsis, with its Advance II, Accel, and Innovate systems for non-sterile applications, will complement EMD’s recently introduced PTS-Micro, a rapid bacterial (bioburden) detection system for sterile biopharmaceutical applications. We expect our enhanced portfolio to drive increased adoption of EMD’s quality control testing solutions across both sterile and non-sterile applications as clients seek a single provider for their rapid product-release testing needs.

CP: What is the size of the combined company?
FJ: CRL has approximately $1.4 billion in annual revenues (2014). With the addition of Celsis, EMD now represents about 13% of our sales.

CP: In what other areas is Charles River looking to grow, either internally or via acquisition?
FJ: Charles River is always working hard to expand our products and services offerings to better support our clients. We do this through a combination of internal R&D, technology licenses, partnerships, and acquisitions.