Demand for rapid microbiology in the biopharma industry is at an all-time high, with the market estimated at more than $600 million, according to recent research conducted by Strategic Consulting, Inc. One of the main drivers in this burgeoning market is regulatory concern about product safety.
 
Foster Jordan, Charles River Senior Vice President, Endotoxin and Microbial Detection (EMD) Products, has led the growth of the EMD business, as well as developed key technologies. He discusses drug safety testing, technologies and processes, contamination issues, and complexities and inefficiencies impacting the lab through to manufacturing. –KB
 
Contract Pharma: What methods and technologies are being developed to alleviate environmental monitoring complexities and inefficiencies? How do they pertain to manufacturing practices and Process Analytical Technology (PAT) guidelines?

Foster Jordan: The rapid, point-of-use, and on-line technologies for environmental monitoring as well as in-process testing, which are key to driving regulatory compliant efficiencies in pharmaceutical manufacturing, are being implemented. In addition, it is essential to develop 21 CFR Part 11 compliant software solutions that can effectively manage a decentralized quality control testing environment. The combination of technologies that provide rapid, accurate (quantifiable) results coupled with complaint data management solutions that allow confident decisions to be made are helping companies meet the goals of PAT.  
 
CP: We’re hearing a lot about drug product recalls and contamination issues. What assessment techniques and testing can be done to avoid this? What are some of the critical issues impacting manufacturing?
 
FJ: Quality of manufacturing is only assured when you use adequate process validation methods supported by the appropriate real-time testing. The largest single impact in pharmaceutical manufacturing today is both historical and cultural. Due to the high regulatory oversight of drug manufacturing, pharmaceutical companies tend to move much more slowly than the semiconductor, food or consumer products industries. The FDA recognizes this and has recently been more proactive in supporting new technologies by publishing guidelines on validating these technologies. The big hurdle right now is developing processes and procedures that support real-time assessment and decision-making rather than the traditional and episodically driven conditions.
 
CP: What shifts in drug safety testing are you seeing from the lab through to manufacturing?
 
FJ: There is incentive for companies to invest in quality by design in the manufacturing process and in process controls and less reliance on the final batch release testing alone. This is due in large part to the cost associated with producing very large batches of advanced therapeutics. Engineering controls, clean room design, continuous monitoring, and rapid in process testing at critical steps provides early detection of contamination events that could result in batch release failures. Early detection allows manufacturers to stop production and reduce unnecessary waste and in some instances this early detection provides critical investigational information to understand the root cause of failures and prevent recurrence.
 
CP: Have there been any regulatory changes with respect to control of microbiological contamination?
 
FJ: There’s considerable focus on environmental monitoring, in-process testing and timely response to out-of-specification microbial results, in addition to heavy emphasis on conducting thorough investigations, determining root cause and implementing effective corrective and preventive action across all areas of manufacturing, specifically microbial contamination events. While regulations pertaining to control of microbiological contamination have remained fairly constant over the last decade, the warning letters related to this topic have increased steadily. Every aspect of production is at continual risk of being a vector for microbial contamination of product. Consequently, advances in aseptic controls, environmental monitoring, sterilization methodology and other production improvements are necessary by an industry that continues to grow.
 
CP: In what markets are you seeing an increased demand for drug safety testing? What has contributed to this growth?
 
FJ: Asia is the biggest regional area of growth across all methods, especially in biological drugs. In the U.S. and Europe, we’re seeing growing interest right now in rapid micro methods (the fastest product segment), biologics and personalized medicine such as cell therapy.   
 
 
Foster Jordan joined Charles River Laboratories via the acquisition of Endosafe Inc. in 1994.  Mr. Jordan joined Endosafe as R&D Director in 1991 and was responsible for the development of our FDA-licensed in vitro endotoxin detection test kits.  Mr. Jordan became Director of Technical Operations in 1994 and in 1997, became General Manager of Charles River Endosafe and assumed responsibility for global In Vitro operations.  He became Executive Director in 2001, Corporate Vice President in 2006, and Corporate Senior Vice President of Endotoxin & Microbial Detection in 2008.