Under the agreement, Lonza will sell and distribute Innosieve Diagnostics’ solid phase cytometry MuScan™ Instrument, Sieve-ID® Total Viable Count Kit and associated software to the pharmaceutical, biotechnology and medical device manufacturing industries.
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 that the bioburden remains low; however, a major challenge with conventional, growth-based bioburden testing is the lengthy time to 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 analyzed within one hour from collection; and up to six samples can be analyzed 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. 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.”
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.”
Innosieve will continue to offer its full range of products, including the MuScan™ System, to all other markets.