Across our three business units Process Solutions, Life Science Services, and Science & Lab Solutions, our R&D teams continue to bring expertise and a diversified and relevant portfolio of products and services to our customers around the world.
As the fields of preventive and personalized medicine evolve, it will be essential to set the standard with robust, scalable, efficient processes for viral vector production, next-generation sequencing and autologous cell therapies. This in turn will support the expansion of disruptive cell and gene therapies to treat the most challenging and chronic conditions, including cancer, heart disease, diabetes, and muscular dystrophy.
To this end, a large number of engineers, chemists and biologists across five global hubs are focused on six strategic innovation vectors: building our core portfolio, factories and labs of the future, novel modalities, next generation biology, AI and digital, and sustainability. In 2023, we launched more than 8,500 products including products under our “faucet program” for antibodies, reference materials, chemicals, and nanomaterials).
Process Solutions*
In January, we introduced the Pellicon® Capsule with Ultracel® membrane, which meets the single-use tangential flow filtration (TFF) device requirements for the antibody-drug conjugate (ADC) manufacturing process. Engineered with operator safety in mind, the Pellicon® Capsule features for easy connection to a single-use TFF system. The capsules are resistant to organic solvents commonly used in the ADC manufacturing process.
In April, we launched Ultimus® single-use process container film, designed to provide extreme durability and leak resistance for single-use assemblies used for bioprocessing liquid applications. Ultimus® film is designed with a proprietary woven nylon structure and provides enhanced bag strength and resilience. This technology is now available in Mobius® 3D process containers.
In July, the Mobius® iFlex Bioreactor was launched as the latest addition to the BioContinuum™ Production and Harvest Platform, our integrated solution for perfusion process development and manufacturing. Alongside our portfolio of EX-CELL® Advanced HD Perfusion, Mobius® Breez Microbioreactor and Cellicon® Cell Retention Solution, the Mobius® iFlex Bioreactor enables customers to realize the efficiency gains and cost savings of production intensification and continuous monoclonal antibody (mAb) manufacturing.
In March, Medicine Maker recognized the Process Solutions business unit with its Best Biopharma Equipment Company award.
Life Science Services*
One key R&D investment for Life Science Services was the expansion of Contract Testing Development and Manufacturing Organization (CTDMO) Services with two new GMP-grade mRNA drug substance manufacturing sites in Darmstadt and Hamburg, Germany. Consequently, our offering is the first to encompass all key stages of mRNA technologies, lipids, lipid nanoparticles (LNP), and fill & finish, including key products and biosafety testing.
Life Science Services received three awards in 2023. In March, it was recognized at Life Science Leader’s 2023 CDMO Leadership Awards in five categories: capabilities, compatibility, expertise, quality, and service. In September, it received the API Development Award for ChetoSensar™ at the 2023 CPHI Pharma Awards as well as the Best Biologics CMO Award at the 2023 Asia Pacific Biologics CMO Excellence Awards 2023.
Science & Lab Solutions*
From nanomaterials enhancing battery performance to optimal media culture for producing lab-cultivated meat, the breadth, and depth of our Science & Lab Solutions portfolio highlights how life science innovation improves important aspects of our daily lives.
The lab of the future
One important driver for the Science &Lab Solutions business innovation is digitalizing the lab of future, with workflows through AI, machine learning, automation, and other solutions. It supports scientists at all stages with tools that can increase efficiency, safety and success rates of delivering new, safer therapies for patients. By combining expertise in small molecules, biologics and new modalities with AI and other digital tools, we are helping to redefine how drugs are discovered, developed and produced.
In December, we launched AIDDISON™ drug discovery software, the first AI-powered software-as-a-service platform that bridges the gap between virtual molecule design and real-world manufacturability through Synthia™ retrosynthesis software Application Programming Interface (API) integration. It combines generative AI, machine learning, and computer-aided drug design to speed up drug screening. Trained on more than two decades of experimentally validated datasets from pharmaceutical R&D, AIDDISON™ identifies compounds from more than 60 billion possibilities that have key properties of a promising active ingredient, such as non-toxicity, solubility, and stability in the body. The platform then proposes ways to best synthesize these drugs.
In February, we launched M-TRACE® All-in-One Computer solution, another example of how we are digitalizing the lab. M-TRACE® offers a cleanroom-friendly way to create test records used during sterility testing and other quality control workflows. Compliant with the QC sterility testing environment, it enables full data traceability.
In November, we launched ChemisTwin™, an online digital reference materials platform. It is a digital reference materials platform that can perform automatic analysis of samples’ purity, identity, and degradation of compounds through over 1,500 calibrated algorithm-based digital references. Reference materials ensure the quality and safety of medicines and other products (such as water, food and beverage) from the earliest stages of research and development through quality control and quality assurance testing.
Efficiency and productivity-enhancing tools
We continued to offer incremental and sustainable technologies that improve productivity challenges to address customers' key challenges. In June, we launched mPAGE® Lux electrophoresis gel, a product that decreases, from 90 to three minutes, the time-consuming and key step of gel casting for western blotting, a method for protein separation.
In December, we launched the Milli-Q® SQ-2 series systems. With eight patents for its innovative features, this ultrapure lab water equipment offers greater flexibility, autonomy and sustainability – with less energy and water consumption. The system does not require a direct connection to a water pipe, so researchers can draw ultrapure water via the equipment at the point of use without any intermediate installations.
The next frontier in cell culture
The launch of 3dGRO™ Patient-Derived Organoids (PDOs) is also opening up new possibilities for researchers. During 2023, we launched 20 pancreatic and 20 colorectal organoids, along with 3dGRO™Wnt3a conditioned media supplement used for organoids. These complex, multicellular 3-dimensional in vitro cell models used in biomedical research that closely mimic in vivo organs are a powerful way to study drug responses, disease progression, and more. An important tool in cancer research, organoids provide a more relevant, phenotypic model of cancer than traditional 2D cell culture models.
* The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically.