Contact: Matthew McRae
(781) 647-3700 ext. 446

Nova Biomedical Announces BioProfile® FLEX2 Cell Culture Analyzer Integration With the ambr® 15
cell culture Microbioreactor System from Sartorius Stedim Biotech

Waltham, MA –Nova Biomedical today announced a collaboration with Sartorius Stedim Biotech (SSB) for integration of the Nova BioProfile FLEX2 comprehensive cell culture chemistry analyzer with the ambr microbioreactor system. Under the terms of the agreement, technical experts from Nova and SSB collaborated to combine the cell culture analysis capabilities of the BioProfile FLEX2 with the automated sampling functions and control software of the ambr® 15 cell culture system. The measured cell culture parameters are directly incorporated into ambr data sets and users are able to implement them in the ambr experimental design and control strategies, including Design of Experiments (DoE).

Incorporating the analytical capabilities of the BioProfile FLEX2 has the potential to save time and reduce errors by dramatically improving laboratory workflows around ambr systems. It will deliver at-line chemistry, gas, cell density/viability, and osmolality monitoring, which will provide scientists with comprehensive analysis of critical cell culture parameters to enhance clone selection, media development, and culture parameter data to confidently optimize process productivity and product quality.

BioProfile FLEX2’s innovative design provides comprehensive analysis of 16 key cell culture chemistries including Gluc, Lac, Gln, Glu, NH4+, Na+, K+, Ca++, pH, pCO2, pO2, Osmolality by freezing point depression, and Total and Viable Cell Density and Viability by trypan blue dye exclusion method. FLEX2 incorporates Nova’s maintenance-free MicroSensor™ Card technology that eliminates sensor maintenance and maximizes workflow efficiency. Its very small sample volume enables automated cell culture analysis for small volume culture systems, such as ambr microbioreactor systems. Other sampling options include manual sampling and two modes for batch sampling: 96-well plates or the built-in 24-position tray.

“Based on customer input and market need, Nova Biomedical created the small volume BioProfile FLEX2 to offer the most user-friendly, maintenance-free system that maintains the flexibility and modularity of the first generation BioProfile FLEX analyzer,” said Matthew McRae, Biotechnology Sales Product Line Manager at Nova. “BioProfile FLEX2 will help to meet the sizable need for automated cell culture analysis for small volume culture systems like the Sartorius ambr microbioreactor systems. No other cell culture analyzer provides a complete cell culture test menu and modular and low maintenance design while providing automated sampling from microbioreactor cultures.”

Dr. Barney Zoro, ambr Product Manager at SSB, continued, “We're delighted to be collaborating with Nova to integrate comprehensive at-line analytics with our ambr platforms. When combined, these two technologies deliver a major advance in Process Analytical Technology (PAT) supporting high throughput bioprocess development workflows. This is a significant addition to Sartorius' ambr platform, further enhancing industry bioreactor DoE capabilities, delivering higher titers, speed to clinic and quality by design.”

Designed for small volume, early stage cell culture development through GMP manufacturing, BioProfile FLEX2 provides 21CFR Part 11 compliance, OPC connectivity, full networking functionality, and support with all validation needs.

About Nova Biomedical
Incorporated in 1976 and based in Waltham, MA, Nova Biomedical is a world leader in the development and manufacturing of state-of-the-art, whole blood, point-of-care and critical care analyzers, as well as providing the biotechnology industry with the most advanced instruments for cell culture monitoring. Nova is one of the fastest growing in vitro diagnostic companies in the world. Nova’s biosensor technology is incorporated in products ranging from handheld meters for glucose self- and point-of-care testing to critical care whole blood analyzers designed for rapid measurement of over 20 analytes. Nova’s biotechnology-specific BioProfile line has pioneered comprehensive cell culture testing, providing over 20 critical cell culture tests with over 12 unique instrument offerings for broad range of cell culture applications. Nova employs over 1,100 people worldwide and has wholly owned subsidiaries located in Brazil, Canada, France, Germany, Great Britain, Italy, Japan, and Taiwan. Certified by the International Organization for Standardization, Nova has manufacturing operations located in the U.S., Taiwan, and Brazil.

About Sartorius Stedim Biotech
Sartorius Stedim Biotech is a leading provider of cutting-edge equipment and services for the development, quality assurance and production processes of the biopharmaceutical industry. Its integrated solutions covering fermentation, cell cultivation, filtration, purification, fluid management and lab technologies are supporting the biopharmaceutical industry around the world to develop and produce drugs safely, timely and economically. Sartorius Stedim Biotech focuses on single-use technologies and value-added services to meet the rapidly changing technology requirements of the industry it serves. Strongly rooted in the scientific community and closely allied with customers and technology partners, the company is dedicated to its philosophy of "turning science into solutions."

Headquartered in Aubagne, France, Sartorius Stedim Biotech is listed on the Eurolist of Euronext Paris. With its own manufacturing and R&D sites in Europe, North America and Asia and a global network of sales companies, Sartorius Stedim Biotech enjoys a worldwide presence. Its key manufacturing and R&D site is in Germany. The company employs approx. 3,700 people, and in 2014 earned sales revenue of 683.5 million Euros.

ambr systems are designed and manufactured by TAP Biosystems (now part of the Sartorius Stedim Biotech Group) a leading global provider of automated cell culture and fermentation systems for life science research, development and production. The ambr systems are widely used for cell line development and process optimization at pharmaceutical, biotechnology and academic laboratories. They are proven to provide a reliable model and consistent scalability to a range of upstream processes.