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Lonza and Innosieve Diagnostics Announce Exclusive Distribution Agreement

hits:139     Date:06/05/18
Lonza and Innosieve Diagnostics Announce Exclusive Distribution Agreement for Rapid Bioburden Testing Technology
 
Cologne (DE) and Wageningen (NL) 04 June 2018 鈥 Lonza Pharma & Biotech and Innosieve Diagnostics announced today an exclusive distribution agreement for rapid bioburden testing technology. This agreement expands Lonza鈥檚 extensive offering of endotoxin products, services and software and provides pharmaceutical testing professionals with a comprehensive set of quality control (QC) tools.
 
Under the agreement, Lonza will sell and distribute Innosieve Diagnostics鈥 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鈥檚 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鈥檚 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, 鈥淏y 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.鈥
 
Dr. Michel Klerks, President and CEO of Innosieve Diagnostics, said, 鈥淗aving 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.鈥
 
Innosieve will continue to offer its full range of products, including the MuScan™ System, to all other markets.
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