We are a leading global provider of tools, chemicals, and equipment to academic labs, biotech and pharmaceutical manufacturers, and the industrial sector. Together with our customers, our purpose is to impact life and health with science. With a strong focus on innovation, we are committed to delivering the products, services, and digital platforms to create a sustainable future for generations to come.
Across our Life Science business sector, we collaborate with the global scientific community to deliver breakthrough innovations supported by a broad and deep portfolio of more than 300,000 products. In early 2022, we announced the reorganization of the sector, with several organizational changes and a new operating model to support Life Science’s long-term growth strategy and to better serve our global customers’ evolving needs.
The changes comprised the following: the existing Contract Development and Manufacturing Organization (CDMO) and Contract Testing (CTO) services were split from the Process Solutions business and consolidated into one global, fully integrated Life Science Services organization for traditional and novel modalities, including monoclonal antibodies, high-potency active pharmaceutical ingredients (HPAPIs), as well as antibody-drug conjugates and viral and gene therapies including mRNA. In addition to manufacturing, Life Science Services includes sales and marketing, research and development, and supply chain operations. In the fall of 2022, we launched a new brand encompassing our integrated services offering Millipore® CTDMO (Contract Testing, Development and Manufacturing Organization) Services to support clients with fully-integrated services from pre-clinical phases to commercial production. Millipore® CTDMO Services operates facilities throughout Europe, the United States, and Asia. Our Contract Testing Services remain under the BioReliance® brand.
The Process Solutions business will continue its focus on delivering our leading product offering for pharmaceutical development and manufacturing, including filtration devices, chromatography resins, single-use assemblies and systems, processing chemicals, and excipients.
The Research Solutions and Applied Solutions business units were combined into one organization called Science and Lab Solutions. This business unit serves the pharma and biotech, industrial and testing, academic and government, and diagnostics sectors, providing customers a more seamless experience and access to a broad portfolio including reagents, consumables, devices, instruments, software, and services for scientific discovery, in addition to lab water instruments, consumables and services, microbiology and biomonitoring products, test assays, analytical reagents, and flow cytometry kits and instruments.
Also announced was the newly created position of Chief Technology Officer, reporting to the Life Science business sector CEO. This leader is responsible for shaping the technology roadmap and long-term R&D strategy, systematically exploring emerging opportunities that lead to breakthrough innovations. Functions such as Integrated Supply Chain and Operations, the Transformation Office, Strategy, Business Development and Sustainability, Quality and Regulatory, and other Group functions remain unchanged.
A key goal for the Life Science business sector is to support customers that manufacture drugs, from small to large innovator companies, and bring safe and effective life-enhancing therapies and vaccines to millions of patients worldwide. To that end, we continued to leverage strategic opportunities to enhance our capabilities and expand our products and services offering.
In 2022, Life Science generated 47% of Group sales and 51% of EBITDA pre (excluding Corporate and Other).
In April, we announced the acquisition of the MAST® (Modular Automated Sampling Technology) platform from Lonza. The MAST® platform, now part of our BioContinuum™ Platform, is a leading automated, aseptic bioreactor sampling system developed in Bend, Oregon, USA. With this acquisition, we add automated sampling to our bioprocessing portfolio, enabling us to become the first provider of a fully integrated ecosystem for advanced process technologies.
In August, we launched the VirusExpress® 293 Adeno-Associated Virus (AAV) Production Platform, making us one of the first CDMOs and technology developers to provide a complete viral vector manufacturing offering including AAV, Lentiviral, CDMO, CTO, and process development. This new platform enables biopharmaceutical companies to increase the speed of clinical manufacturing while reducing process development time and costs. It is an extension of our VirusExpress® offering, which can reduce process development time by up to 40%, based on our experience as a CDMO. In the same month, we also launched Pellicon® capsule manifolds for single-use tangential flow filtration (TFF) production. Uniquely designed for faster installation and safer handling of filtration areas, Pellicon® Capsule manifolds offer ease-of-use for scale-up from clinical to small-volume production of biomolecules.
In December, we acquired Massachusetts-based Erbi Biosystems, a developer of the two milliliter (mL) micro-bioreactor platform technology known as the Breez™. The deal strengthens our upstream portfolio by enabling scalable cell-based perfusion bioreactor processes from 2 ml to 2,000 L with rapid lab-scale process development. It also offers future development opportunities in novel modality applications.
Life Science Services*
In January, we strengthened our CDMO services across the mRNA value chain with the acquisition of Exelead. Exelead specializes in complex injectable formulations, including Lipid Nanoparticle-based drug delivery technology. We plan to invest more than € 500 million in the technology scale-up of Exelead over the next ten years. This will further enable us to capture the significant potential of the fast-growing market for mRNA therapies by providing leading CDMO services to our customers.
In June, we doubled our high-potent active pharmaceutical ingredients production capacity with the expansion of our facility in Verona, near Madison, Wisconsin, USA. This new € 59 million, 6,500 square meter facility brings 50 new jobs to the area.
In October, we announced the opening of a new commercial facility to support our new Millipore® CTDMO Services offering at our site in Martillac, France. The 2,700 square meter facility will support our clients as they work with our global CTDMO network, including templates for drug development, manufacturing, and commercialization, to accelerate molecules to market.
In November, we entered into a collaboration with Biotheus, a China-based biotech company focused on developing treatments for cancer and autoimmune diseases. This collaboration will help accelerate the drug submission and approval process for the biopharmaceutical industry in China using our first-to-market Blazar® Rodent Panel for virus testing, reducing animal testing through molecular-based technology and biosafety turnaround time by up to 80%.
Science and Lab Solutions*
In February, we collaborated with Waters Corporation to build and expand an Extractables and Leachables (E&L) Reference Library to include ion mobility measurements. The library will enable analytical labs to identify potential extractables and leachable compounds in their samples by using Waters’ ion mobility-enabled liquid chromatography-mass spectrometry (LC-MS) instruments and then confirm the identity and quantity using our Supelco® reference materials. The library is cross-linked to our Life Science business sector’s online product catalog to provide users access to reference materials to confirm their results.
We also expanded our ZooMAb® recombinant monoclonal antibodies product portfolio with 72 new products and added 23 new products to the ColorWheel® flow cytometry antibodies and dyes portfolio. ZooMAb is the first-ever antibody to receive the ACT label designation and received the lowest environmental impact factor (EIF) scores in the chemicals and reagents category.
In the Life Science business sector, our dedication to the customer experience extends from the lab to our primary e-commerce platform, sigmaaldrich.com, which connects tens of millions of visitors in nearly every country around the world with the products, services, and technical expertise needed to advance their discovery, research, and development further and faster. We have accelerated our rate of eCommerce innovation by improving our site speed, expanding our product document library, and making it easier for customers to find what they need with new, differentiating user experiences.
Investments to expand capabilities and production*
In April, we announced a € 100 million investment for our first Asia-Pacific Mobius® Single-Use Manufacturing Center in Wuxi, China. This investment supports the fast-growing biotech innovation sector in China and is realized in close collaboration with the Administrative Management Committee of the Wuxi National High-Tech Industrial Development Zone to jointly cultivate and enhance the life science ecosystem in the Wuxi area and throughout China.
In May, we announced an investment of approximately € 440 million to increase membrane manufacturing capacity in Carrigtwohill and build a new manufacturing facility at Blarney Business Park, both in Cork, Ireland. The investment, the largest in a single site ever for the Life Science business sector, will create more than 370 permanent jobs by the end of 2027.
In July, we broke ground at our site in Sheboygan, Wisconsin, USA, for our first lateral flow membrane production facility in the United States. Lateral flow membranes are vital in rapid diagnostic test kits for various applications, ranging from Covid-19 to other infectious diseases. The new facility is supported by a € 121 million contract award from the U.S. Department of Defense on behalf of the U.S. Department of Health and Human Services. The Sheboygan location further supports our competitive advantage by providing improved supply security and reduced lead times for global customers.
In September, we announced an investment of more than € 130 million to strengthen our manufacturing capabilities for single-use assemblies, a key technology for the production of Covid-19 vaccines and other lifesaving therapies, in Molsheim, France. The investment is the largest ever in the 50-year history of the site and will create more than 800 jobs by the end of 2028.
Also in September, we opened a new viral clearance (VC) laboratory as part of the first building phase of our new € 29 million Shanghai-based China Biologics Testing Center. The 5,000 square meter center, the first of its kind for our company in China, is designed to meet the double-digit demand for VC testing services in the country. Customers will now be able to locally conduct viral clearance studies from pre-clinical development to commercialization, a critical step in drug development required by regulatory agencies to complete clinical trials necessary to move to commercial manufacturing. The second phase of the center’s facilities will open in late 2023 and offer cell line characterization and lot release testing services.
In November, we announced a € 290 million investment in a new facility to support the increasing demand for biosafety testing services at our Rockville, Maryland, USA, site. The new 23,000 square meter facility will consolidate the multi-building campus into one facility that will open in 2024 to significantly increase our biosafety testing capacity, creating over 500 new jobs in the region. This is the largest testing investment in company history.
From pandemic to endemic*
As the Covid-19 pandemic devolves into an endemic, we continue providing customers with products and solutions that empower scientists to study long-term effects, detect and characterize viruses, and develop and manufacture vaccines and therapies. We have supported more than 35 testing solutions across RT-PCR, antigen, and antibody diagnostics for both high-throughput centralized and distributed point-of-care settings; more than 80 different vaccine programs, consisting of several platforms that include DNA, Inactivated, Live Attenuated Virus, Viral Vector, Protein Subunit and mRNA; and more than 50 monoclonal antibodies, plasma-derived products, and antiviral treatments.
* The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically.