Pioneers in Antibody Research
Antibodies at work
Antibodies are Y-shaped proteins produced by the human body as part of a normal immune response to foreign molecules. Molecules from invading organisms – such as viruses, bacteria and other harmful organisms – are called “antigens” and prompt the body’s B-cells to make antibodies by the billions. Each antibody has two antigen-binding sites (one on each arm of the Y) and works to neutralize these invaders.
Antibody medicines are designed to emulate this natural disease-fighting process and, with the help of scientific innovation, do much, much more.
Antibodies as medicines
Antibody medicines are based on key principles of biology and mimic the natural defenses and pathways of the human body and immune system. Scientists look at how antibodies work in order to replicate and optimize them against specific disease targets. Now antibody medicines can be created in a lab and given to people who need them for a specific medical purpose. These antibody medicines are derived from living organisms, not from chemical processes like most pills. Because antibody medicines specifically target disease-causing antigens, they are designed to avoid unwanted effects on other cells in the body.
Antibody medicines have been proven to change lives and have altered the course of the treatment of serious diseases like asthma, cancer, heart disease, severe eczema, Ebola and COVID-19 over the past several decades.
Antibody creation: The Regeneron approach
At Regeneron, we know that not all antibody medicines are created equal. Antibody medicines are discovered, developed and tested through a rigorous process that can take up to 20 years, and require special expertise. At Regeneron, our innovative technologies have accelerated and improved this traditional process. We are antibody pioneers. Our deep scientific expertise has allowed us to discover, develop and manufacture many antibody medicines – and antibody-targeted medicines – from beginning to end.
Follow each step to see our approach in action
Target discovery and validation
Through researching human biology, our scientists identify targets that can be linked to the onset, progression or even prevention of a disease. After a target is identified, it is often validated through further research in animal models.
Regeneron’s process starts with our deep belief in the power of genetics and our fundamental understanding of basic biology. In the early 2000s, we generated one of the first “knockout” mice in biotech history, which allowed us to study how certain genes (or the absence of certain genes) affect health and disease.
Our continued leadership in mouse genetics capabilities – a key stepping stone for the development of antibody medicines – resulted in the development of our VelociSuite® technologies, starting with VelociGene® and VelociMouse® for superior disease modeling and target exploration.
We continue to push the frontiers of genetics research with the Regeneron Genetics Center® – one of the largest and most ambitious efforts to pair human DNA sequences with deidentified health records to find rare people who are resistant to disease so that we can identify new drug targets and facilitate better treatments.
VelociGene rapidly tests and validates drug targets in mice and, in 2006, was selected as the technology of choice by the National Institutes of Health in the “Knockout Mouse Project,” an unprecedented effort to determine the function of thousands of unknown genes.
VelociMouse dramatically shortens the timeframe needed to engineer genetically modified mouse models, while reducing cost and improving precision.
Therapeutic development and preclinical research
Once a target is validated, a specific antibody is identified, developed and optimized. After a viable antibody is discovered, it is tested in preclinical disease models to measure its effects and safety. In order to test the medicine, it’s necessary to find a way to increase production of the antibody in small but consistent batches.
Regeneron's core capabilities for the discovery and development of antibody medicines are enabled by VelociMab® and VelocImmune®, which efficiently produce a multitude of optimized fully human antibody medicine candidates.
VelociMab enables high-throughput screening of potential therapeutic antibodies and the rapid generation of cell lines for recombinant human antibodies, a necessary step to arrive at the production scale needed for clinical testing.
VelocImmune is the leading platform for the efficient production of fully human antibodies. The genetically modified VelocImmune mouse is extraordinarily productive at generating antibodies that can be rapidly reformatted into medicines.
While VelocImmune mice have been genetically modified to produce human antibodies, their immune systems have been precisely maintained to operate as those in normal mice. This enables a process of natural selection to produce optimized antibody candidates that are well-suited to become medicines, thereby increasing overall efficiency in the drug-development process.
Clinical development
Only the safest, most precise and effective antibody medicines move on for testing in people. Researchers work with regulatory authorities to design clinical trials that answer specific questions related to a medicine’s safety, optimal dosing and efficacy. Clinical trials typically follow a three-phased process and grow in scale over each phase. This process can take several years to complete. The resulting data are shared with regulatory authorities around the globe who will independently assess the safety and efficacy of the antibody medicine.
Our innovative mindset extends beyond the labs, as we seek to make clinical trials safer, more efficient and more informative.
Learn more about our robust pipeline of investigational product candidates that strive to address a broad range of serious medical conditions.
Manufacturing for commercial use
Antibody medicines must be manufactured on a large scale in order for them to be available for appropriate patients. This is a highly integrated bioengineering process that requires consistency and reliability to meet regulatory requirements.
At Regeneron, we don’t believe that all antibody medicines are created equal. We take pride in our superior manufacturing processes, facilities and Industrial Operations and Product Supply (IOPS) team, which enable the reliable, safe and consistent creation of antibody medicines. We are constantly seeking improvements to enhance the elegance and efficiency of these processes.
Antibodies of the future
Antibody medicines are an established class of treatment that are only getting better with the help of cutting-edge science. Regeneron is leading the way, developing new technologies to help discover better and novel antibody medicines. While most of our approved medicines are fully human monoclonal antibodies, we are exploring newer types of antibody medicines, including bispecific antibodies and antibody drug conjugates (ADCs).
Advancing the science of bispecific antibodies
Bispecific antibodies are engineered to bind two different molecular targets – meaning each arm of the “Y” reaches out to attach to something different. For example, one arm may attach to a tumor cell while the other captures a T-cell. The antibody medicine activates the T-cell to attack and destroy the harmful tumor cell.
We are applying our powerful development platforms to design minimally engineered, fully human bispecific antibody medicines that resemble naturally occurring antibodies as closely as possible. Veloci-Bi® allows for the generation of full-length bispecific antibody medicines that can be made via standard manufacturing techniques with the goal of having favorable properties similar to natural antibodies.
Retargeted antibodies
Tapping into our deep expertise in antibodies, Regeneron is uniquely suited to select exquisitely specific antibodies paired with genetic editing tools to deliver the tools directly to the tissue. Delivery of genetic editing tools – gene editing like CRISPR, gene silencing or siRNA, and gene therapy – is a particularly challenging part of genetic medicines, making our retargeted antibodies a useful delivery mechanism for this approach.
