Lonza and Sanquin partner for commercialization of specialized MAT reagents for accurate and reliable in vitro pyrogen testing

Press release

▪ Lonza Sales AG, through its Bioscience Division has joined forces with Sanquin Reagents B.V. to enable drug developers and quality control laboratories to take full advantage of the power of the Monocyte Activation Test (MAT)

▪ The new partnership will facilitate the global access to the sustainable, highly sensitive methodology for in vitro pyrogen testing essential for the safety of parenteral pharmaceuticals during development, manufacture and release to market

▪ Under the agreement, Sanquin’s cryopreserved pooled human Peripheral Blood Mononuclear Cell-based MAT method will be added to Lonza’s extensive portfolio of pyrogen testing products

▪ Advantages of the MAT assay are most prominent for complex formulations, such as human vaccines and biologics, where other common testing methodologies used to ensure product safety may display technical limitations

Archie Cullen, Vice President, General Manager Testing & Informatics Solutions, Lonza:
“Drug developers and manufacturers are increasingly turning to innovative new technologies that can facilitate accurate, reliable detection of pyrogenic contamination in their products to safeguard patient health. At Lonza, we are committed to delivering novel solutions that can effectively address this need. By expanding our QC testing portfolio with Sanquin’s state-of-the-art, sustainable MAT kits, we can now provide our customers with a complete toolkit they can rely on to ensure product safety.”

Dr. Harry Bos, Managing Director/CEO, Sanquin Reagents B.V.:
“By combining our scientific knowledge and technical expertise on MAT kit production and testing with Lonza's extensive reach and experience with endotoxin testing and data analysis, we will bring the benefits of this powerful technology to a wider audience across the pharmaceutical and biotechnology industries, and further improve the safety of parenteral therapeutics.”

Basel, Switzerland, 28 May 2020 – Lonza Sales AG, through its Bioscience Division and Sanquin Reagents B.V. have entered into a strategic partnership for the commercialization of a range of specialized reagents for pyrogen testing of parenteral pharmaceuticals and medical devices using the Monocyte Activation Test (MAT). This partnership expands Lonza’s extensive portfolio of endotoxin testing products, and enables drug developers and quality control (QC) laboratories to explore the full potential of the high-performing, sustainable MAT method to bring safe pharmaceuticals to the market.

Contrary to the conventional Rabbit Pyrogen Test (RPT), which works by measuring temperature changes in rabbits following administration of a test sample, the MAT does not involve the use of experimental animals. As such, it enables QC laboratories to comply with stringent animal welfare regulations and meet their sustainability objectives. Being a highly sensitive in vitro human cell-based assay, the MAT is capable of consistently detecting pyrogenic activity in even the most complex pharmaceuticals, such as vaccines and cell- and antibody-based biologics, where use of the RPT is limited.

Under the new agreement between Lonza and Sanquin, cryopreserved pooled human Peripheral Blood Mononuclear Cells (PBMCs) produced by Sanquin specifically for use with the MAT will bear the Lonza branding. The cells are developed in line with the requirements of the European Pharmacopoeia chapter 2.6.30, following an optimized donor selection, cell isolation and cell quality testing process. Compared to fresh PBMCs, cryopreserved pooled PBMCs eliminate the need to undertake cell isolation for each single test run. As a result, the cells are available on demand whenever a need arises and large number of vials from one batch guarantee a long term test consistency. Lonza will further distribute the Sanquin-branded PeliKine compact ELISA Kits that have been validated for use with the MAT assay. Together with Lonza’s testing hardware, media and accessory offering, drug developers and QC laboratories will now profit from a comprehensive and optimized MAT solution that is in line with regulatory requirements.

For more information about Lonza’s complete testing product offering, please visit https://bioscience.lonza.com/lonza_bs/CH/en/endotoxin-testing For information of Sanquin’s products & services offering, please visit https://www.sanquin.org/mat.

About Lonza
Lonza is an integrated solutions provider that creates value along the Healthcare Continuum®. Through our Pharma Biotech & Nutrition segment and our Specialty Ingredients segment businesses, we harness science and technology to serve markets along this continuum. We focus on creating a healthyenvironment, promoting a healthier lifestyle and preventing illness through consumers' preventive healthcare, as well as improving patient healthcare by supporting our customers to deliver innovative medicines that help treat or even cure severe diseases.

Patients and consumers benefit from our ability to transfer our pharma know-how to the healthcare, hygiene and fast-moving consumer goods environment and to the preservation and protection of the world where we live.

Founded in 1897 in the Swiss Alps, Lonza today is a well-respected global company with more than 100 sites and offices and approximately 15,500 full-time employees worldwide at the end of 2018. The company generated sales of CHF 5.5 billion in 2018 with a CORE EBITDA of CHF 1.5 billion. Further information can be found at www.lonza.com.

About Sanquin
Sanquin is responsible for the safe and efficient supply of blood and blood products in the Netherlands on a not-for-profit basis. The company also develops and manufactures advanced transfusion pharmaceutical products, conducts high-quality scientific research and provides a multitude of diagnostic reagents and services for blood transfusion and immunology. Further information can be found at www.sanquin.org.

Lonza Contact Details

Dr. Kristin Koehler
Investor Relations
Lonza Group Ltd
Tel +41 61 316 8782

Dr. Sanna Fowler
Head of External Communications
Lonza Group Ltd
Tel +41 61 316 8929

Sanquin Contact Details

Dr. Harry Bos
Managing Director, CEO
Sanquin Reagents B.V.
Tel +31205123599

Additional Information and Disclaimer
Lonza Group Ltd has its headquarters in Basel, Switzerland, and is listed on the SIX Swiss Exchange. It has a secondary listing on the Singapore Exchange Securities Trading Limited (“SGX-ST”). Lonza Group Ltd is not subject to the SGX-ST’s continuing listing requirements but remains subject to Rules 217 and 751 of the SGX-ST Listing Manual.

Certain matters discussed in this news release may constitute forward-looking statements. These statements are based on current expectations and estimates of Lonza Group Ltd, although Lonza Group Ltd can give no assurance that these expectations and estimates will be achieved. Investors are cautioned that all forward-looking statements involve risks and uncertainty and are qualified in their entirety. The actual results may differ materially in the future from the forward-looking statements included in this news release due to various factors. Furthermore, except as otherwise required by law, Lonza Group Ltd disclaims any intention or obligation to update the statements contained in this news release.