Agreement Expands Availability of Rapid Test for Bioburden

A distribution deal with Innosieve Diagnostics (Wageningen) has enabled Lonza Pharma & Biotech (Cologne) to offer an alternative to growth-based bioburden test which can also make the procedure faster. 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. 

Control of bioburden during the manufacturing process is a regulatory requirement for the manufacture of drugs and medical devices; a major challenge with conventional, growth-based bioburden testing is the lengthy time to results. 

Innosieve’s non-growth-based testing approach, is said to enable a single sample to be analysed within one hour from collection and up to six samples within two hours.

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.