All four areas in which the Bioscience business operates support evolving market needs across drug discovery, development and manufacturing. Our business covers For Further Manufacturing (FFM) Cell Culture Media, Discovery Solutions, Testing Solutions and Software / Informatics Solutions.
In the Discovery market, recent developments in Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) and non-viral, ex-vivo gene therapy are driving demand for alternative processes, such as nucleofection. At the same time, new applications in in vitro toxicology and immunotherapy are driving demand for liver cells and immune cells, supporting custom cell biology services.
Several developments and trends drive demand for offerings in the informatics and testing markets. Large biotech and pharmaceutical companies are actively adopting global, integrated and automated solutions in quality control and manufacturing environments. Traceability and data integrity within current good manufacturing practices (cGMP) are becoming a critical part of the manufacturing and release process for many of these companies. With cell and gene therapy on the rise, there is an increasing need for cost-effective and flexible IT systems, which can be rapidly deployed to improve decision making, quality and compliance needs.
Our Bioscience business is a market-leading provider of specialty raw materials and enabling technology solutions in core target markets including cell and gene therapy, injectable drugs, vaccines and bio-manufacturing.
We serve customers across the world in academic and government institutions, as well as in major biotech and pharmaceutical organizations. Our offerings provide our customers with tools to develop, manufacture and test therapeutics, from basic research to final product release. We are equipped with solutions, manufacturing capabilities and scientific expertise to work for our customers as they advance from research, through translation, to clinical production. Our global network ensures consistently high standards of quality, compliance and supply security, and provides access to a range of resources to partner with our customers for any challenge.
Bioscience Products Filed with Regulatory Agencies
Primary Cell Types
Key Production Sites
Scientific Publications Used a Lonza Bioscience Product in 2020
Our FFM Cell Culture Media business serves customers in the bioprocessing market. FFM Cell Culture Media are used at various stages in the development and production of therapeutics, including antibodies, antibody drug conjugates (ADCs), viral and classical vaccines, and cell therapy treatments including CAR-T.
Our Discovery Solutions support customers in disease research, drug discovery and development and cell and gene therapy. Our offerings include products and services targeting cardiovascular, respiratory, neurological, metabolic, cancer and other disease-research areas. Our Nucleofector® Transfection technology enables highly efficient transfection of human cell types that have traditionally been difficult to transfect. This enables customers to advance non-viral transfection methods for cell and gene therapy, and to leverage the transformative potential of CRISPR gene editing technologies.
Our Testing Solutions provide a complete portfolio for endotoxin and pyrogen testing, including traditional and sustainable methods with fully integrated automated solutions. Our products and platforms are applied for quality control testing and product release in the pharmaceutical, medical device and dialysate markets.
Our fully integrated Software / Informatics Solutions streamline quality control processes for biologics and cell and gene therapies, and offer insight into manufacturing operations, with quick access to management, compliance and trending data. Our MODA-ES® Platform is a comprehensive solution that bridges the current gap between manufacturing and quality control to provide a single batch record with an intuitive review and approval interface.
Our Bioscience business serves customers across the world with a network of seven key production sites.
Our Bioscience business experienced a solid level of organic growth from existing customers over the course of 2020. Our sites remained operational and the business reviewed its commercial operations to improve both customer experience and operational efficiency. We reported high single-digit sales growth for the year, along with margin gains, driven by efficiency improvements 1.
Forecasts for 2021 anticipate low double-digit sales growth. This will be supported by continuing digital investment and innovation to maintain and extend existing customer relationships. Looking to the future, we are confident in anticipating growth at around 10% to 12% 2 (versus 6% to 8%) 3 on an annual basis for the next three years (CAGR 2020 – 2023).
Comparison versus 2019 at a constant exchange rate (CER)
Based on volume; Source: Internal Analysis
Bioscience is strongly positioned to support the fight against COVID-19, with our extensive offering of cell biology products for respiratory disease research and development of treatments and vaccines. We were able to rapidly support an increased demand for our respiratory cell products and worked directly with our customers to optimize our offering to suit the quickly developing needs of the research community as they tackled this global pandemic.
COVID-19 presented a significant challenge to our Discovery Solutions customers in 2020, as many research labs were closed during the second quarter. However, our team found creative ways to support our customers as they continued to work remotely, by providing extensive online tutorials, virtual device demos and other initiatives that helped to keep projects running. This allowed a rapid increase in activity as scientists returned to their laboratories.
In 2021, we will celebrate the 20th anniversary of the Nucleofector® technology with a launch of next generation formats and products for use in clinical manufacturing workflows.
In 2020, we launched a new medium – the first chemically defined, non-animal origin medium, to enhance and accelerate the production of Adeno Associated Virus (AAV) in Spodoptera Fuigiperda (Sf9) insect cells. The TheraPEAK® SfAAV™ Medium accelerates cell growth, increases productivity and reduces process variability and costs, expediting time-to-market for safe, scalable, life-saving gene therapies.
We have also expanded our cell culture media portfolio with the addition of the GSv9™ Media and Feeds, providing a fully integrated solution specifically designed to optimize recombinant protein production using our GS Gene Expression System®. The new chemically defined, animal-free origin media and feeds are robust, easy to implement and enable greater batch-to-batch consistency. As a result, biopharmaceutical manufacturers can more easily develop streamlined and scalable bioproduction processes.
Last, but not least, various FFM cell culture media have been deployed throughout 2020 in support of multiple COVID-19 related projects globally.
In 2020, we expanded our extensive portfolio of endotoxin testing products, through a strategic partnership with Sanquin Reagents B.V. for the commercialization of a range of specialized reagents for pyrogen testing of parenteral pharmaceuticals and medical devices using the Monocyte Activation Test (MAT). The new partnership will facilitate global access to the sustainable, highly sensitive methodology for in vitro pyrogen testing. This is essential for the safety of parenteral pharmaceuticals during development, manufacture and release to market. As part of this partnership, we have launched PyroCell® MAT System, which combines Sanquin’s optimized MAT reagents with our media and accessories, providing customers with a complete testing solution.
Within our core testing products, we saw a strong uptake in WinkQCL® 6.0 Endotoxin Software upgrades arising from the launch and associated support contracts in the previous year. In addition, our fully automated and integrated PyroTec® PRO System extended its application to bring on board turbidimetric reagents. This automated solution continues to gain global traction with multi-site placements in mid to large pharmaceutical companies and to support an increase in testing volumes associated with vaccine release.
In Informatics, we expanded our MODA-ES® Platform and functionality with the launch of the ELogs module. The MODA-ES® – Electronic Batch Record Solution was also successfully implemented across two of our cell and gene therapy sites in the last 12 months, enabling the digitalization of cell and gene therapy manufacturing operations for greater operational efficiency. Already in use by many major vaccine manufacturers, the MODA-EM® Solution for paperless QC Microbiology was selected by The Vaccine Manufacture and Innovation Center (VMIC) in the UK to support its vision of a paperless facility and meet its ambitious timelines.