Apart from scientific problems encountered during R&D, another drug challenge is varying classes of medicines, e.g. small molecules, biotherapeutics, and vaccines are usually characterised by systemic scientific challenges. Solutions for one drug class may not be applicable for other drug classes that the technological focus is fundamentally different.
Biotherapeutic medicines are derived from proteins and other compounds produced by living organisms, such as cells, viruses, and bacteria. Biotherapeutics aim to closely mimic compounds that are naturally produced in the human body. R&D in this area is often more complicated than small molecules research because underlying organism’s genetic and molecular makeup must be fully understood in order to induce production of therapeutic compounds.
Like small molecules development, biotherapeutics R&D begins the with discovery, formulation and medicine interaction. The discovery process generally involves mapping biotherapeutics interactions. However, biotherapeutics are complicated because it is produced from living organisms, protein folding, and functional group orientation. Therefore, they are very sensitive to experimental conditions e.g. temperature, pH, etc. In addition to understanding the aforementioned process, researchers must genetically map living organisms to produce therapeutic compounds.
Although the research is successful, companies still face the problem of scaling up production to launch to market. This process is completely different from small molecules. Having living organisms as the underlying compounds, it is difficult to mass produce this type of medicine.
Vaccines are biological products that help build human immunity. Vaccines are derived from antigens which are surface proteins of living organisms. With the right amount of antigens, vaccines aim to stimulate antibody production in patient’s immune system so that the immune system is equipped to combat future infections that exhibit corresponding antigens.
The discovery of vaccine focuses on identifying pathogenic antigens. This process involves studying a pathogen’s surface proteins and identifying candidate antigens that can be further developed. Next, it is to study the antigen safety. Since the antigen will eventually be injected to human body, antigen safety studies are essential to determine whether immunological responses are proportional to the introduced antigens, for example, viral vaccines e.g. influenza, can utilize whole virus, split virus, surface virus, or live attenuated antigens. Therefore, there is no “one size fits all” answer for vaccine use.
When appropriate and safe antigens and vaccines are found, the R&D shifts to scaling up the production of antigen and formulating effective and safe inoculations. Similar to biotherapeutics R&D, it is difficult to scale up the production because of the living organisms used to produce antigens. Meanwhile, other research focuses on formulating appropriate inoculations. The goal is to produce a preparation that is relatively stable in a variety of “in the field” conditions for vaccine needs.