Rapid bioburden testing distribution agreement made
Lonza Pharma & Biotech will sell and distribute Innosieve Diagnostics’ MuScan Instrument, Sieve-ID total viable count kit
The distribution agreement made between Lonza Pharma & Biotech and Innosieve Diagnostics will 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 1 hour from collection; and up to six samples can be analysed within 2 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.
