Lonza & Innosieve Diagnostics Announce Exclusive Distribution Agreement

Lonza Pharma & Biotech and Innosieve Diagnostics recently 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 ensure 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.

Lonza is one of the world’s leading and most-trusted suppliers to the pharmaceutical, biotech and specialty ingredients markets. As an integrated solutions provider, Lonza is boosting its value creation along and beyond the healthcare continuum with a strong focus on patient healthcare, consumer preventive healthcare and consumer’s healthy environment.

Lonza harnesses science and technology to create products that support safer and healthier living and that enhance the overall quality of life. With the recent Capsugel acquisition, Lonza now offers products and services from the custom development and manufacturing of active pharmaceutical ingredients to innovative dosage forms for the pharma and consumer health and nutrition industries.

Benefiting from its regulatory expertise, Lonza is able to transfer its know-how from pharma to hygiene and fast-moving consumer goods all the way to coatings and composites and the preservation and protection of agricultural goods and other natural resources.

Founded in 1897 in the Swiss Alps, Lonza today is a well-respected global company with more than 100 sites and offices and approximately 14,500 full-time employees worldwide. The company generated sales of CHF 5.1 billion in 2017 with a CORE EBITDA of CHF 1.3 billion. For more information, visit www.lonza.com.

About Innosieve

Innosieve Diagnostics BV is a product company operating through its R&D facilities in Wageningen, The Netherlands.

Innosieve Diagnostics is focused on development and sales of simple, Rapid Microbial Methods, including optical devices in the pharmaceutical, biotech and industrial sector. The rapid and direct microbial diagnostics of Innosieve Diagnostics are mainly applied for process monitoring, end product testing and hygiene screening. By combining diagnostic expertise with Rapid Microbial Method development, Innosieve Diagnostics offers customized solutions of high quality for its customers. For more information, visit www.innosieve.com.