A drug’s journey from lab bench to medicine cabinet is arduous and likely doomed from the start. Of the nearly 20,000 compounds considered for a treatment, only 10-20 may actually produce the intended results. (1) As your laboratory embarks on this road, critical to your success is a clear understanding of each part of the process. Below, we lead you through the pharmaceutical product development journey, from R&D to clinical trials, and for the lucky few, to the shiny golden pot of manufacturing.
Research & Development
Research and development (R&D) usually begins when researchers begin working to understand the molecular mechanism underlying a specific disease’s development. Once they have identified a target, or molecule that can be manipulated to prevent or delay disease onset, the search begins for a compound that can act on this target. Once identified, the compound of interest undergoes intensive testing to determine its efficacy and safety, the two central measures of drug quality, particularly during the drug development process. Acceptance into clinical trials typically assumes successful preclinical testing in laboratory animals and cells. (2)
Before a potential drug can enter clinical trials, researchers must submit an Investigational New Drug (IND) application with the FDA. This application includes pre-clinical study results, manufacturing information, clinical protocols, and investigator information. (3) Application approval allows the drug to move into the following clinical trial phases:
- Phase 1: The goal of Phase I is to assess a drug’s safety. Researchers use a small sample population, approximately 10-20 people, to determine dosage limits, absorption mechanism, and overall body response.
- Phase II: Now that safety has been established, Phase 2 determines drug effectiveness. Slightly larger groups, approximately 20-40 people, are given either a single dose or varied doses across treatment groups.
- Phase III: Drugs that progress to Phase III have demonstrated both safety and efficacy, and are ready for testing among significantly larger sample sizes, typically hundreds to thousands of individuals. Phase III of clinical trials can last for multiple years, and when completed, the drug can be submitted for FDA approval.
Although many thousands of compounds are tested in the R&D phase and some even survive into clinical trials, only 1 per 5,000 potential drugs will enter manufacturing. The final stage of the drug development process, manufacturing is not the end of the road. Pharmaceutical companies must determine how to mass-produce their drug in a cost-efficient manner while still maintaining its quality. (4)
Pion: Scale-Up Homogenizers for Drug Development
The products that successfully traverse the journey from idea to consumer cabinet are few and far between. This is why it is critical that if you have a potentially successful product, it is scaled up into each new stage appropriately. Pion manufactures homogenizers that cater to each stage of the drug development process; therefore, as your drug progresses through R&D to clinical trials to manufacturing, its demonstrated safety and efficacy will be uncompromised.
Pion's BEE brand homogenizers that can yield a variety of relevant products, such as emulsions, suspensions, dispersions and lipids. Importantly, these products go on to make up the injectables, inhalants, anesthetics, and vaccinations that attain FDA approval for manufacturing. In addition, Pion has extensive experience assisting its product users as they transition through the drug development process.