At Kymos, recognized leader in comprehensive laboratory testing, we are privileged to have an entire department dedicated to microbiological testing for sterile and non-sterile API’s and drug products. Karen Reboulaz, Manager of the Microbiology Department, shares with us a deeper insight in her team’s work and the reasons why a significantly increasing number of clients choose Kymos for meeting their microbiology needs:
“Microbiological testing plays an essential role in pharmaceutical manufacturing and drug product release. According to Pharmacopeia, microbiological investigations are mandatory for pharmaceutical quality control. As a matter of fact, our company is well placed to offer all necessary quality control tests, including physico-chemical and microbiological assays. This comprehensive analytical offer makes pharmaceutical companies select Kymos for quality control and batch release of their products. Kymos services include external quality control, as well as backup services, to partner with limited microbiology department resources.”
Regarding the subject of full package services, microbiology usually contributes to projects led by other departments as part of our general Chemistry, Manufacturing & Control (CMC) analytical services:
“Having a Microbiology laboratory, using innovation and performance, adds a lot of value to our services”, Karen Reboulaz explains. “Our collaborative team has a great synergy with our colleagues from Analytical Development, Stabilities and Quality Control, because most of their analytical studies require microbiology. Our microbiology services complement the analytical development of antibiotics since we can develop and validate microbiological methods for assay determinations. Likewise, we participate in ICH stability studies and carry out in-use stability studies of multidose products and injectables that must be reconstituted. Ultimately, our services complete the batch testing and CMC studies of drug substances and drug products including biologics. We support this integrated process by optimizing laboratory workflows, streamlining repetitive tasks, increasing productivity, improving traceability, and reducing contamination and error rates. This strategy ensures the integrity and accuracy of test results.”
Indeed, Kymos provides a wide range of microbial testing for GMP-compliant quality control including both small and large molecules. Mrs. Reboulaz further comments on that:
“In the early days, our team worked mainly with small molecules. Over the years, the demand for assays with biologic sterile injectables has increased dramatically”, she states. “At present we are authorized and fully equipped to conduct assays quickly and accurately for a broad range of products, including non-sterile and sterile drugs for both human and veterinary use, investigational medicinal products (IMPs) as well as medical devices, phytopharmaceuticals, dietary supplements and cosmetics. Our facilities feature a clean room, laminar flow cabinets and safety cabinets, and an Isoflex-S® isolator equipped with a Steritest® pump and H2O2 sterilizer for microbial testing.”
Being asked about new developments, Karen confirms that Kymos is committed to continuously invest in the extension of its services range:
“We are well-known for our flexibility on the ever-changing market needs and for our knowledge to adapt the analytical demands towards new trends. We already entered the market of bacterial endotoxin testing but given the increased demands for such services, we are currently reinforcing our endotoxin offer with a new Nexgen Endosafe® instrument for high-throughput Kinetic Chromogenic LAL assays. Moreover, we have also implemented the Gel Clot method since it is a very extended method and recommended by the European Pharmacopoeia.”
Altogether Ms. Reboulaz strongly believes that being recognized as a reliable partner for microbiology testing also has to do with the day-to-day delivery. She concludes with a final statement:
“Within its financial and resource boundaries, my team understands perfectly well that the successful execution of microbiological diagnostics heavily depends on careful validation, on accurate and timely communication of results, and on real-time quality monitoring. This is our ambition, this is our goal, this is what we are working on for our customers, every day…”
