Technology Innovative technologies lead
to medical progress

Join us for a series decades in the making.

We explore millions of genetic codes, advance drug discovery through technology, identify powerful genes and triumph against the most challenging diseases.

Follow Regeneron's quest for Spectacular Science.

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The biotech industry uses innovation and science to create life-changing new medicines. Historically, this has taken years or even decades. At Regeneron, we’ve worked to accelerate this process, by making each step more efficient.

Here’s how our process typically works –

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First, we identify points of potential medical intervention by studying biological processes. This is known as a ‘target’.

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Then, we research further and generate animal models to confirm this target works the way we think it does, and that our medicine should work as intended.

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Next, we use our novel technologies to invent an effective medicine. At Regeneron, we make biologics – protein medicines made in living cells.

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We then test our drug candidates in animal models to evaluate if they’re effective, safe and tolerable before moving into human studies.

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Medicines that are demonstrated to be safe in animal studies are moved into clinical trials in human volunteers, where we again rigorously evaluate safety and efficacy.

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Once the investigational medicine has passed all these stages, we submit our data to regulatory authorities for review and approval, manufacture the medicine on a larger scale, and deliver it to people in need.

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Developing a new medicine is incredibly difficult: only 8% make it from candidate selection to treating patients; and even then, the process can take over 12 years and cost over 2 billion dollars.

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At Regeneron, we’ve identified bottlenecks in the drug discovery and development process, and developed VelociSuite, our own toolkit of innovative technologies, to address them.

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Our technologies provide a greater chance of producing effective medicines that benefit human health. We deploy them at all stages of the process; which has been instrumental in developing novel therapeutic antibody medicines for diseases, including COVID-19 and Ebola.

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Regeneron sits at the intersection of technology and biology, and our scientists have changed the way medicines are made. We have successfully produced nine FDA-approved medicines with dozens more in the pipeline – all furthering our mission of helping people in need by turning science to medicine.

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The drug discovery and development process is the way we use science to create new medicines. Once we identify a target, a protein or pathogen that may be involved in disease progression, we must ensure this target can be modified by a drug, in a process known as ‘target validation’.

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A common way to do this is to use genetically engineered mouse models to incorporate target-associated or disease-causing mutations identified in humans, or “knock out” specific genes. In this way, we use these models to understand how the target influences the progression or prevention of disease.

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Traditionally, incorporating these genetic alterations into a mouse model involves replacing the gene of interest in mouse embryonic stem cells, or ES cells, with its human counterpart. ES cells are the raw materials used to generate every cell in a mouse. Therefore, successfully engineered ES cells can be used to generate mice with the specific genetic changes to mimic human diseases. However, this method is inefficient, imprecise and time-consuming.

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To overcome these issues, we developed VelociGene a high throughput, largely automated technology to generate genetically engineered mice.

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VelociGene uses bacterial artificial chromosome vectors, or BACvecs, that enable the deletion or insertion of DNA into the mouse genome.

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We introduce these BACvecs into mouse ES cells and precisely and efficiently replace the target mouse gene. Finally, we screen to rapidly identify the successfully-genetically-altered ES cells.

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VelociGene allows us to generate mice bearing almost any genetic alteration in the gene of interest regardless of size or complexity, including expression of human genes. It streamlines the target validation process and has been instrumental in the development of medicines for a wide range of diseases.

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VelociGene was one of the first technologies in Regeneron’s VelociSuite portfolio, laying the groundwork for more technological innovations and creative applications.

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In the drug discovery process, once we identify a biological target that plays a role in human disease, the stage is set for therapeutic development. At Regeneron, we specialize in production of fully human monoclonal antibodies, medicines that utilize the natural properties of your immune system to provide a line of defence against the disease.

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Antibodies are naturally occurring proteins produced by B-cells in response to a foreign antigen. They consist of a constant region which interacts with components of the immune system and a variable region which recognizes and binds to its target with high affinity and specificity. These properties can be taken advantage of to address many different diseases. Therapeutic antibodies have been used for over 3 decades, with their production constantly evolving and expanding across therapeutic areas.

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The generation of therapeutic antibodies in mice is a common method that mimics the same natural process that occurs in humans. However, antibodies generated in mice are often not effective medicines as they do not last long in the human system and can stimulate unwanted immune responses. Therefore, we sought a way to modify these therapeutic antibodies to be fully human.

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At Regeneron, we utilized the power of VelociGene to create the VelocImmune mouse, currently recognized as the premier platform for generation of fully human antibodies, creating optimized antibody drug candidates efficiently from immunized mice. In VelocImmune mice, we precisely replace the 6 million base pairs of DNA that code for the variable region of antibodies with their human counterpart by utilizing the power of VelociGene. By keeping the constant region of the antibody gene of mouse origin, we allow the mouse immune system to naturally select the best response. Therefore, when the target protein is introduced into the VelocImmune mice the immune system is triggered to elicit a strong immune response, producing a broad diversity of target specific, high-quality antibodies with human variable regions.

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VelocImmune mouse is one of the largest genetic engineering projects ever undertaken in mammals and has been used to create multiple novel FDA- approved therapies.

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As we’re developing a new medicine, we must confirm that our investigational medicine binds to the target of interest; produces a response that can alleviate disease symptoms and will be safe in humans.

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A mouse immunization model is often used to generate therapeutic antibodies and due to the natural diversity of the immune response, these mice produce antibodies with varying characteristics – making them useful therapeutic tools.

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At Regeneron, our VelocImmune mice generate high quality human antibodies that bind to our target of interest. But they also produce millions of other antibodies that do not bind to the target or may interact in a suboptimal way.

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We developed VelociMab to sort through the vast range of antibodies generated by our VelocImmune mice.

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VelociMab works by labelling VelocImmune mouse antibody-producing cells with fluorescent dyes to mark the best ones so we can more easily sort the cells that generate thousands of potential therapeutic antibody candidates for a particular disease. To increase the scale of antibody generation, we copy the DNA from the selected mouse cells to our proprietary cell lines designed for industrial scale production.

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About two weeks after we transfer DNA to these cell lines, we choose the strongest candidates from the thousands of potential antibodies to produce at large scale including the high quality antibodies we then test and prepare for clinical trials in humans.

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During the DNA transfer, we make the antibody fully human: replacing the mouse constant region of the antibody with a human constant region so that no trace of mouse sequence is left, thus avoiding an unwanted immune response in humans.

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VelociMab allows us to efficiently sort through massive pools of antibodies making it a pivotal tool in the identification of new therapeutic antibody medicines.

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At Regeneron, we continually push the boundaries of science to discover life-changing, innovative medicines that improve human health.

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To solve the human body’s most complex mysteries, we must continually build upon our existing technologies while also exploring new applications and approaches, like VelociBi and CRISPR.

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Antibodies have two heavy chains and two light chains. Bispecific antibodies, are antibodies that can bind to 2 different targets simultaneously because they have different arms.

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To create bispecifics, chains of 2 different antibodies need to be paired. To overcome common issues that can arise when creating bispecifics such as aggregation, undesired immune responses or instability in vivo, Regeneron developed VelociBi. Using VelociBi, we introduce natural substitutions into the heavy chain on one side of the antibody’s tail, to allow efficient purification of the bispecific antibody and to create more natural bispecifics that are more likely to be accepted by the human immune system. To maximize this approach, both antibodies must utilize the same light chain. To do this, we create VelocImmune mice that only express 1 universal light chain, so that any two antibodies made in these mice that bind to different targets could be combined into a bispecific.

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Our VelociBi approach enables us to create high quality bispecifics at faster speeds.

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Another way we are continually evolving our scientific approach is by tapping into new technologies developed by collaborators, like CRISPR-Cas9. CRISPR can be programmed to cut and modify specific sites in isolated DNA creating a powerful tool for the potential treatment of genetic diseases. As a relatively new technology, CRISPR in humans is still being studied to ensure its safety and effectiveness.

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In collaboration with Intellia Therapeutics, Regeneron is developing CRISPR-based in vivo medicines, including a potential therapeutic for people with Transthyretin Amyloidosis polyneuropathy, a multisystem, debilitating disease. Our recent early clinical results in this disease were the first-ever to look at the safety and effectiveness of in vivo CRISPR genome editing in humans.

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Our scientific exploration of the genetic drivers of disease doesn’t stop there. We are investigating viral gene delivery of an antibody-guided enzyme-replacement therapy to potentially treat a class of genetic diseases. Through our collaboration with Alnylam, we are also exploring innovative approaches to turn off, or silence, disease-causing genes using short interfering RNA. At Regeneron, we are scientific trailblazers. Our proprietary technologies are vital to our mission of discovering and developing important medicines that improve human health. We’ll continue to push the boundaries of science and technology to help people in need for decades to come.