Across our three business units, Research Solutions, Process Solutions, and Applied Solutions, our R&D teams of more than 2,000 employees continue to bring expertise and a diversified and relevant portfolio of products and services to our customers around the world. In 2020, our Life Science business sector focused on delivering the promise of accelerating access to health for people everywhere by collaborating with the global scientific community.
As such, we launched more than 18,300 products in 2020, including those launched through our “faucet program” for antibodies, reference materials, chemicals, and nanomaterials. These included key innovations from all our business units, such as our GenElute™-E Single Spin DNA kits, MILLIPLEX® immunoassay kits and ZooMAb® recombinant antibodies from Research Solutions; the sodium-acetate granulated, Bio4C™ Orchestrator, our perfusion-ready bioreactor, Cellicon™ perfusion device and controller, and VirusExpress™ Lentiviral production cells from Process Solutions; and the Milli-Q® IX 7003/7005/7010/7015 Type 2 water purification system from Applied Solutions.
The engine behind the solutions for Covid-19
As a global life science tools and equipment supplier, we are committed to providing the critical research and diagnostic tools, products, and reagents, therapy manufacturing and vaccine development products, as well as biosafety testing that can aid the global scientific effort to fight this novel virus. We continue to support many of our customers working on Covid-19 projects through our products and services, providing for more than 35 different testing solutions across RT-PCR, antigen and antibody diagnostics for both high-throughput centralized and distributed point-of-care settings; more than 50 different vaccine candidates, consisting of several platforms that include DNA, inactivated, live attenuated virus, viral vector, protein subunit and mRNA; and more than 20 monoclonal antibody, plasma products, and antivirals.
We remain conscious of ensuring ease of access to our broad product portfolio, especially amid the rush to develop solutions for Covid-19. Leveraging our industry-leading e-commerce website, www.sigmaaldrich.com, we created a dedicated Covid-19 webpage that provides a one-stop-shop of more than 200 products and corresponding information for scientists working on Covid-19 research and potential vaccines. In doing so, we continue to support the significant increase in research of Covid-19, coronaviruses and related immune responses, much of which uses our products such as enzyme-linked immunosorbent assays (ELISAs), ZooMAb® recombinant antibodies, and MILLIPLEX® multiplex panels to study Covid-19-related serological and immunological responses.
To expand our capacity for manufacturing Covid-19 related products and critical therapies, in November, we invested US$ 47 million in a combined expansion of our facilities in Jaffrey, New Hampshire, USA, and Danvers, Massachusetts, USA. Both sites supply critical products to customers developing life-saving therapies, including Covid-19 vaccines, such as single-use and virus filtration technologies.
Collaboration remains an important focus for the Life Science business sector as we work to drive innovation and solve the industry’s toughest problems, especially those related to Covid-19. While delivering on our own portfolio and capabilities, we also seek to collaborate with other key players in the industry to work toward our shared goal of bettering and increasing access to health globally. As such, we joined Oxford University in the United Kingdom in their announcement that they laid the foundation for large-scale production of the Covid-19 vaccine candidate, ChAdOx1 nCoV-19, which leveraged our previous collaborative work to develop the manufacturing process for a rabies vaccine candidate. Our support enabled the development of the manufacturing process, which would normally take at least six months to a year, to take place in just two months’ time, saving valuable time for the vaccine developer.
We also announced an extension of our ongoing collaboration with Baylor College of Medicine in Houston, Texas, USA, which previously focused on vaccine development for tropical disease outbreaks, to now advance a vaccine manufacturing platform for Covid-19. Our joint work supports the accelerated transition to Phase I clinical trials, optimizing the production process to advance two Covid-19 vaccine candidates, including the CoV RBD219-N1 vaccine candidate originally developed to target SARS. Additionally, our new collaboration with the Massachusetts Institute of Technology’s (MIT) Center for Collective Intelligence and Community Biotechnology Initiative began with the release of a report detailing potential paths to solutions for pandemic response. The report summarizes the results of a three-week collective intelligence exercise conducted with more than 180 science, healthcare, and policy experts from around the world, which generated suggestions to combat Covid-19 via transmission control, diagnostics, and monitoring, and accelerating access to vaccines and therapies, among other technical topics.
We announced another new collaboration with Mammoth Biosciences Inc., of San Francisco, California, USA, for the development, scale-up and commercial production of their CRISPR-based DETECTR BOOST™ SARS-CoV-2 Reagent Kit. Once this new test isapproved by the FDA, Clinical Laboratory Improvement Amendments labs in the U.S. will be able to significantly improve capacity to regularly perform testing. Mammoth recently secured funding from the National Institute of Health’s RADx program to scale its CRISPR-based testing workflow and we will serve as contract manufacturer for this high-throughput Covid-19 test.
Additionally, we have worked with academic partners to license or co-develop ELISAs, monoclonal antibodies, MILLIPLEX® panels, and proteins and scaled up those tools to become more broadly available to the research community.
Further, we are empowering virtual R&D by leveraging smart technology to collaborate with our customers and stakeholders. Our teams provided virtual offerings and interactions, including a self-service portal for audit stakeholders, a global pilot study of Emprove® Smart Glasses Kits, and digital collaborations and trainings at our M Lab™ Collaboration Centers using cutting-edge tools like Microsoft Surface Hub that allow customers to get a first-hand view from the lab floor and explore solutions virtually.
Throughout the year, our R&D teams have demonstrated exceptional agility while navigating the impacts of the Covid-19 pandemic. Our colleagues have worked swiftly and diligently to accelerate necessary product launches, pause on others and bring new, innovative ideas into the pipeline and launch within months.
In September, we launched the MILLIPLEX® SARS-CoV-2 antigen panels for IgG, IgA and IgM. These panels utilize multiplexing technology to simultaneously detect the presence of different antibody classes against four different SARS-CoV-2 protein antigens in a single reaction from human serum or plasma samples. These panels were developed in close collaboration with academic researchers to deliver excellent sensitivity and specificity.
We continue to support the significant increase in research about Covid-19, coronaviruses, and related immune responses, much of which uses our products such as enzyme-linked immunosorbent assays, ZooMAb® recombinant antibodies and MILLIPLEX® multiplex panels to study Covid-19-related serological and immunological responses. We also collaborated with academic partners to apply our retrosynthetic analysis software for novel synthesis of critical antiviral drugs with cheaper or alternate starting materials, alleviating supply chain problems. Furthermore, we focused on delivering critical raw materials for use in antiviral drug synthesis or for Covid-19 diagnostic kit manufacturing.
Our major launches in 2020 include the Scepter™ 3.0 handheld cell counter, Genelute™-E Single Spin DNA kits, a full DNA Encoded Library (DEL) technology, proteolysis targeting chimeras (PROTACS), MILLIPLEX® kits, and an additional 200 ZooMAb® recombinant antibodies.
Over the course of the year, we continued to deliver solutions for today’s biomanufacturing processes while developing leading-edge technologies for the factories of the future. In April, we unveiled our Bio4C™ Software Suite, a first-of-its kind digital ecosystem that combines process control, analytics and plant-level automation. It includes two browser-based platforms: the Bio4C™ ProcessPad, which will allow users to acquire, aggregate and analyze data from disparate sources such as equipment, batch records, databases and historians across the bioprocess; and the Bio4C™ Orchestrator, which will provide remote access to systems, recipes, reports, user accounts, and alarms from a holistic process dashboard. Part of our expanding BioContinuum™ Platform, this transformative software suite allows users to look across the entire manufacturing process versus individual operational units, giving biomanufacturers complete process control and deep insights, bringing Bioprocessing 4.0 to the here and now.
With this launch and others, our BioContinuum™ pipeline continues to drive the biopharmaceutical industry on a journey to evolve and digitize the next generation of bioprocessing to increase speed and reduce costs. Additional launches from this year include our BioContinuum™ Buffer Dilution 30L System, part of the BioContinuum™ Buffer Deliver Platform; our perfusion-ready bioreactor, Cellicon™ perfusion device and controller for seed train intensification with optimized process control; and the Cellvento® 4CHO-X expansion medium.
In October, we announced our collaboration with D1Med, a Shanghai-based biopharmaceutical startup and precision-medical company, to advance the application of three-dimensional (3D) cell culture technology in China. As part of the collaboration, we will provide D1Med with 3D cell culture products and application support, including local and global expertise to co-develop the 3D cell culture protocol for PDO applications, which come from humans and mimic the biological characteristics of the original tumor as tools to study cancer development, drug screening and disease modelling.
Additionally, in November, we announced our collaboration with Transcenta, a global biotherapeutics company, to advance continuous biomanufacturing with strategic technology implementation. The collaboration will co-develop a first-of-its-kind, single-use, flow-through polishing system for GMP operation. The first phase of this multi-year partnership will focus on developing and designing the process technologies, single-use system and automation, while the second phase will focus on an expanded scope of process and digital technologies to optimize a continuous manufacturing process.
With more than 35 years of experience in the development and manufacturing of small molecules, biologics, and antibody-drug conjugates (ADCs), we offer extensive experience in both clinical and commercial manufacturing. In September, we continued investing in ADC technologies with an expansion of our manufacturing capacities at our site in Madison, Wisconsin, USA, marking another critical advancement of increasingly potent compounds for therapies that have the potential to treat cancer.
To further advance our portfolio of gene-editing and novel modalities, in October, we launched the VirusExpress™ Lentiviral Production Platform to bolster our viral vector manufacturing capabilities and offer a simplified upstream workflow that makes processes easier to manage, adjust, and scale. This new platform helps to overcome lentiviral production challenges and can reduce process development time by approximately 40%, based on our experience as a contract development and manufacturing organization. In addition to accelerating process development, the VirusExpress™ Platform’s suspension culture format allows each batch of virus to be larger, yielding more patient doses while being amenable to true scale-up and less labor-intensive. The chemically defined medium also eliminates the safety, regulatory, and supply chain concerns related to animal- and human-derived materials. This marks the latest of our continued investments in the rapidly growing cell and gene therapy market.
Our company has 16 years of experience in genome editing, from early development to manufacture. Our portfolio now includes 28 patents for CRISPR technology, granted worldwide, including six additional patents granted in 2020. We were awarded our second U.S. patent for CRISPR-chrom technology and two U.S. patents for foundational CRISPR-Cas9 technology. In June, we joined 10x Genomics, a single-cell and spatial genomics technologies company, in announcing our development of two linked technologies: single-cell transcriptomics and pooled CRISPR screening. This is the first solution for simultaneous gene perturbation measurement and unbiased single-cell gene expression. Further, in October, we announced our agreement to license CRISPR technology to two companies: PanCELLa, a cell therapy firm based in Toronto, Canada, and Takara Bio USA, Inc., a biotechnology company based in Mountain View, California, USA. The licenses aim to accelerate drug discovery leading to development of new therapies.
The growing potential of CRISPR technologies also raises scientific, legal, and social questions. We support genome-editing research only after careful consideration of ethical and legal standards. Our work is guided by our Bioethics Advisory Panel, an independent panel made up of a diverse group of international biomedical experts that provides guidance for research in which our businesses are involved.
We also announced a global licensing agreement with ReForm Biologics, a pharmaceutical technology company in Woburn, Massachusetts, USA, for excipient development and commercialization. The collaboration will accelerate R&D activities and GMP manufacturing for ReForm’s excipients, making them available to our customers for use in biologic formulations.
Since 2018, 63% of drugs in the pipeline were being developed by biotech start-ups focused on innovative therapies, including those intended to treat niche diseases with small patient populations. Our global health commitment focuses on these companies and supports bringing their drugs to market through our grant programs. Grants provide selected companies with access to our products and services to help accelerate market entry for new therapies. Through our Advance Biotech Grant Program, which we run in North America, Europe, and Asia, we announced two grant recipients for 2020, selected based on the scientific and societal merit of their respective therapies in development, as well as process challenges and expertise gaps. Additional finalists were also announced.
To continue strategically advancing our core capabilities, in May, we launched the Milli-Q® IX 7003/7005/7010/7015 Type 2 water purification system, a redesigned version of our benchtop pure water system that provides laboratories with a reliable and consistent source of high-quality pure water. This is a smaller and more intuitive and ergonomic device than previous generations of the water purification system. For half a century, we have been the partner of choice for water purification systems and services for lab scientists who need to ensure their water is free of contaminants. This new system goes a step further to incorporate a range of sustainable purification technologies and design features aimed at minimizing environmental impact. Additionally, in January, we launched the new Milliflex Oasis® System to provide enhanced result reliability, increased productivity, and advanced traceability. The system offers enhanced benefits for pharmaceutical bioburden and water testing, including 96 new features, while streamlining the bioburden testing workflow.
Life Science has more than 30 years of experience in the diagnostics space, and our products and capabilities have played a significant role in Covid-19 testing efforts, as evidenced by our collaboration with Mammoth Biosciences. Covid-19 developments and other advancements in the area of innovative personalized medicines have resulted in an increased demand for more rapid sterility testing solutions to support the development and release of these products. Additionally, we continue to establish new growth opportunities and capabilities in contract development and manufacturing services. In February, we announced that our business was selected by Elypta, a molecular diagnostics firm in Sweden, as the contract manufacturer for their Research Use Only (RUO) clinical diagnostic liquid biopsy kits. Once validated and commercialized, the kits will be intended to improve the accuracy of cancer diagnoses by analyzing metabolites deregulated in several cancer types. The kits will be manufactured at our facility in St. Louis, Missouri, USA.
We remain focused on advancing digitalization, especially our offering of digital lab productivity tools. To continue growing our laboratory informatics solutions to create the labs of the future, in February, we introduced the BrightLab™ platform. The tool brings Internet of Things (IoT) integrations to R&D, meeting the increasing demand for data automation and accessible, real-time monitoring of centralized and synched lab data. Additionally, in March, we launched the LANEXO™ system. This first-to-market digital lab informatics solution offers radio-frequency identification (RFID) labels, cloud-based integration, mobile and web applications for easily accessible digital data capture and real-time documentation. These solutions recognize the increasing demand for data automation that can be easily set up and rapidly integrated into existing lab workflows to ultimately help speed up the discovery process.
Increasing digital tools while adding to our titration portfolio, in March, we launched a new SmartChemicals technology that uses Supelco® SmartTitrants and Supelco® SmartStandards to transfer data seamlessly to a titrator. With this new technology, an RFID label is embedded on our Titripur® volumetric solutions, Certipur® volumetric standards and all Aquastar® Karl Fischer titrants and standards. These RFID labels store all relevant data from the Certificate of Analysis, which helps eliminate time-consuming steps and errors by transferring data wirelessly and instantly to titration instruments.
Recognized for award-winning innovation
To begin the year, Life Science received a 2020 CMO Award from Life Science Leader and Outsourced Pharma, an honor determined based on primary market research and customer feedback. The award honors outsourcing respondents who exceed customer expectations with their capabilities, compatibility, expertise, quality, reliability, and service.
In July, our DOZN™ green chemistry tool won Environment + Energy Leader’s Top Project of the Year award. The award recognizes excellence in environmental, sustainability, and energy management. With more than 300 active, registered users, the DOZN™ system helps customers make data-driven decisions to increase environmental sustainability by evaluating the relative greenness of chemicals and chemical processes against the 12 Principles of Green Chemistry. Additionally, in recognition of our continued effort to create safer, more sustainable solutions, our Stericup®E and Steritop®E filtration devices were awarded New Product of the Year by Business Intelligence Group through its BIG Awards for Business program.
Also in July, we were recognized with two awards at INTERPHEX 2020, which honors the future of pharmaceutical, biotech and device development and manufacturing innovation. Our BioReliance® Blazar™ Platform won the Editor’s Choice Award while our BioContinuum™ Buffer Delivery Platform, one of our BioContinuum™ Platform’s newly launched building blocks, received Best in Show. We received two additional awards at the 2020 Asia-Pacific Bioprocessing Excellence Awards. Our BioContinuum™ Platform was awarded Best Bioprocessing Innovation of the Year, and the Life Science business sector was awarded Best Bioprocessing Supplier of the Year in Downstream Processing.
Our Blazar™ platform was honored with two additional awards in 2020. First, the CPhI’s Excellence in Pharma award for its analysis, testing, and quality control, which recognizes innovations for and dedication to driving the pharmaceutical industry forward. Second, the Blazar™ platform also won a prestigious R&D 100 Award for analytical and testing capabilities, recognizing the global best that are pioneering revolutionary ideas in science and technology. Bio4C™ ProcessPad, part of our expanding BioContinuum™ Platform, also made the shortlist for the 2020 CPhI Awards.
We also received the CiteAb award for Innovative Product of the Yearfor our ZooMAb® Recombinant Antibodies. This new range of recombinant monoclonal antibodies is manufactured using a proprietary expression system as well as with less preservatives and freeze-dried, making shipping easier and giving long-term stability. Further, our LANEXO™ system won the Gold German Design Award for excellent communications design apps, recognizing how helpful digitalization can be in boosting efficiency, optimizing safety, and simplifying compliance in the regulated analytical and research laboratory.
* The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically.