The Swiss contract manufacturer will sell and distribute a microbial diagnostic tool from the Dutch company
Lonza Pharma & Biotech has signed a distribution agreement with Dutch microbial test specialist, Innosieve Diagnostics, to offer increased availability of rapid bioburden testing technology.
Under the agreement, Lonza will sell and distribute Innosieve Diagnostics’ MuScan Instrument, Sieve-ID total viable count kit and associated software to the pharmaceutical, biotechnology and medical device manufacturing industries.
Dr Claus-Dietmar Pein, head of business development for Bioscience Solutions at Lonza Pharma & Biotech, said: “By expanding our QC testing portfolio with this rapid, easy-to-use bioburden testing method, we can help increase product safety, speed up processing time and reduce costs of bioburden detection as end-users will no longer have to wait several days for their results.”
Control of bioburden during the manufacturing process is a regulatory requirement for the manufacture of drugs and medical devices.
Bioburden testing is performed to assure the bioburden level remains low; however, a major challenge with conventional, growth-based bioburden testing is the lengthy time for results.
Innosieve’s MuScan Instrument and Sieve-ID Total viable count kit offer a non growth-based bioburden testing approach that enables a single sample to be analysed within one hour from collection; and up to six samples can be analysed within two hours.
The technology employs solid-state cytometry to detect stained microorganisms that are captured on the patented Sieve-ID filter. Innosieve’s new 21 CFR Part 11-compliant software then determines the number of viable cells present and records the results in an easy-to-read and auditable report.
Dr Michel Klerks, president and CEO of Innosieve Diagnostics, said: “Having received excellent feedback from our current customers, we are now working with Lonza to supply our innovative bioburden-testing technology to the pharmaceutical and biotechnology QC industries.”
The agreement expands Lonza’s offering of endotoxin products, services and software and will provide pharmaceutical testing professionals with a comprehensive set of quality control (QC) tools.