When the Immune System Attacks: Developing Biologics as an Alternative to Waiting It Out

Biologics Development

Biologic drugs, which are administered through IVs or via syringe, are a new class of therapy to treat autoimmune diseases. Can we develop more specific and potent biologic drugs?
Image source: Flickr user Lisle Boomer

Most people live in harmony with their immune systems. For them, the immune system is able to distinguish pathogens from the organism’s healthy tissue1 and can prevent disease by initiating non-specific or antigen-specific responses to pathogens. But for up to 50 million Americans, their immune systems become the source of disease when their cellular components begin to attack healthy cells.2 The most common types of autoimmune diseases include rheumatoid arthritis, Type 1 diabetes, multiple sclerosis and lupus.3 Though less prevalent, vitiligo is another well-known autoimmune disorder.

Each disorder is characterized by the organ system or body parts that are marked as foreign and thus subject to destruction. In rheumatoid arthritis it is the joints, whereas for Type 1 diabetes the pancreas is targeted and in vitiligo the melanin-producing skin cells are attacked. In general, to treat autoimmune disorders, medications are prescribed to control or inhibit the immune response.4 Immunosuppressive drugs, however, prevent patients from being able to mount an attack against infectious disease, leaving them susceptible to serious illnesses among other complications.5 Is there then another way?

Biologics as an Alternative to Immunosuppressive Drugs

Instead of nonspecific immunosuppressive drugs, the targeted therapy provided by biologic drugs is a powerful alternative. Essentially, biologic drugs are antibodies that are targeted against a specific component of the immune system that is overactive. Most biologic drugs function by targeting cytokines, B cells and co-stimulation molecules.6 Many have been developed for rheumatoid arthritis and biologic drugs such as Rituximab (Rituxan) and Ofatumumab (Arzerra) specifically target CD20, a protein expressed on the surface of B-cells which increases in concentration as the B-cells mature.7 Other popular targets for biologic drugs include TNF-alpha, a protein made by the immune system that can cause inflammation. Research is ongoing to determine more specific molecular targets for biologics in order to reduce off-target effects. Much work remains and research efforts must be dedicated to uncovering novel biologic drugs that work ever more precisely.

To facilitate this discovery process, companies interested in creating biologic drugs should consider how they can facilitate the identification and screening of potential therapeutic solutions. The experiments required in these processes, however, often generate large amounts of data that can easily descend into chaos if the discovery process is not organized into a workflow through which researchers can document experiments and analyze and manage information. Following are more specific components of the discovery process that researchers should consider as they determine how best to manage their data:

Antibody sequencing and modifications: As mentioned, currently available biologic drugs are modifications of antibodies that target components of the immune system. Importantly, there is often a high volume of antibody sequence data that must be acquired and analyzed in order to determine if and when a new antibody has been created or if modifications of existing antibodies could be made resulting in a profound effect on the potency and efficacy of biologic drugs.

Maintain cell line data: In the line toward discovery, the use of cell lines to test promising antibodies is essential. There must be a method by which researchers can test many different cell lines and if an opposite effect is discovered between two, for example, screen and sequence the cell lines to determine if the change is because of some alternative mechanism of action of the biologic drugs between samples. This could have important implications on the function of the biologic drug.

To support these goals and many more, researchers should consider utilizing software that enables them to store and manage large volumes of sequence and cell line data. Software may also include other features, such as registration systems, assay management and the maintenance of regulatory and compliance systems. To determine how the BIOVIA Biologics Solution can assist your firm in uncovering the next best biologic drugs, please contact us today.

  1. “Immune System,” September 13, 2015, https://en.wikipedia.org/wiki/Immune_system#Layered_defense
  2. “Autoimmune Disease, July 22, 2015, http://www.healthline.com/health/autoimmune-disorders#Types2
  3. “What are Autoimmune Diseases,” February 16, 2015, http://www.webmd.com/a-to-z-guides/autoimmune-diseases
  4. “Autoimmune Disorders,” http://www.nytimes.com/health/guides/disease/autoimmune-disorders/overview.html
  5. “Developing Strategies to Induce Tolerance in Autoimmune Diseases,” http://www.fda.gov/BiologicsBloodVaccines/ScienceResearch/BiologicsResearchAreas/ucm258777.htm
  6. “Biologic therapy for autoimmune diseases: an update,” 2013, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3616818/
  7. “CD20,” August 30, 2015, https://en.wikipedia.org/wiki/CD20

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