Lonza Pharma & Biotech and Innosieve Diagnostics announced an exclusive distribution agreement for rapid bioburden testing technology. This agreement expands Lonza’s 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’ 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.
Innosieve Diagnostics, a Dutch company, develops applications for the detection of micro-organisms.