From Identification to Approval: How Automated Aliquoting Advances Drug Discovery Research
Modern medicine has made huge strides in the past century thanks to drug discovery research. This field of scientific research revolutionized healthcare with the introduction of antibiotics, antivirals, chemotherapy, and other forms of treatment. Scientists use biology, chemistry, and pharmacology in drug discovery to identify molecules that safely treat various infections and diseases. Drug discovery research leads to products that improve patients’ quality of life and in some cases, save lives, but it requires an intensive, lengthy process.
What are the stages of drug discovery research?
Target Identification and Validation
The first step in drug discovery is identifying a target, typically a protein, gene, or RNA implicated in a disease. Researchers use various techniques including genomics, proteomics, and bioinformatics to discover and study these targets. Experiments are conducted to validate that the target is relevant and can be influenced by a drug to produce a desired effect - typically stopping or reversing effects of a disease.
Hit Identification
Once a target is validated, the next step is to find molecular compounds that interact with it. This is often done through high-throughput screening where thousands of compounds are tested for their ability to bind to or inhibit the target. Compounds that present desired activity against targets in initial screenings will be identified as “hits.” There will typically be a small number of promising compounds that move on for further study.
Lead Optimization
Researchers will then modify the chemical structure of hit compounds to improve their potency and selectivity. Information will be gathered regarding absorption, metabolization, and excretion to determine best dosage and potential side effects. The goal is to develop a lead compound with the potential to become a drug candidate.
Preclinical Testing
Lead compounds undergo rigorous preclinical testing before introduction to patients. Cell cultures and animal models may be used to further evaluate the safety, efficacy, and pharmacokinetic properties. Researchers must determine how the drug will behave in humans, identifying any potential toxicity or harmful side effects. All findings will be reviewed to decide whether the drug should be tested in human patients.
Clinical Trials
If preclinical testing is successful, the drug candidate moves into clinical trials where researchers closely study effects in humans. This stage of drug discovery research is broken into three phases:
Phase I: Safety and dosage of the drug candidate will be tested in a small group of volunteers with the targeted disease or condition. Researchers answer questions related to how it works in the body, side effects associated with increased dosage, and how best to administer the drug. Goals are to limit risks and maximize benefits.
Phase II: Efficacy and potential side effects are further monitored in a slightly larger group of patients.
Phase III: The drug's effectiveness is tested in a large, diverse patient population. This pivotal phase provides the most safety data. Due to being larger and longer in duration, results are more likely to catch long-term or rare side effects.
Regulatory Approval
If clinical trials prove that the drug is safe and effective for intended use, the drug discovery and development team can file a New Drug Application or a Biological License Application to regulatory agencies such as the FDA (U.S.) or EMA (Europe). The agencies review the data to approve or deny the drug for public use.
Post-Market Monitoring
Even after a drug is approved and on the market, it is continually monitored to catch any limitations that may arise after wider use. Agencies will review reported problems and can add cautions or usage information as applicable.
Drug discovery research often takes years. A lengthy, multiphase study is necessary to ensure the safety of new drugs. Early stages can catch detrimental issues before ever being introduced to the public. However, while large amounts of safety and efficacy data are gathered in the beginning phases, it is impossible to have complete drug information at the time of clinical trials and even approval. The later phases of drug discovery and development, allow researchers to piece together the full picture of drug effects.
In addition to time investment, the rigorous process of drug discovery also requires high levels of precision throughout studies. Researchers cannot afford to waste time and materials with inaccuracies that often go hand-in-hand with manual tasks. Laboratory automation like automated aliquoting systems are frequently used in the beginning stages of drug discovery research due to the many benefits they bring to the laboratory table.
How is automated aliquoting successfully implemented in drug discovery?
Facilitating High-Throughput Screening (HTS)
During the stage of hit identification, thousands of compounds are tested for biological activity through HTS. Automated aliquoting systems significantly speed up the screening process by rapidly preparing pre-measured portions of each compound. Precision tools integrated into automation like the Scinomix AQ’s air displacement pipettor also reduce the potential for human error, increasing the chances of identifying promising drug candidates.
Compound Library Management
In addition to benefiting the creation of a compound library, automated aliquoting helps laboratory personnel organize and track samples. The Scinomix AQ Aliquoting System incorporates automated tube labeling along with aliquoting to ensure consistent, legible identifiers. Each compound can be easily retrieved for testing throughout the stages of drug discovery research.
Clinical Trial Compliance
This late stage of drug discovery requires precision and compliance with regulatory standards. Automation offers scalability, accurately managing the needs of Phase 1 trials to the large-scale demands of Phase 3. Many substances used in drug discovery, like biological samples, are sensitive to temperature, light, and humidity. Precise aliquoting reduces risk of degradation by reducing the number of times a bulk sample is exposed to these conditions. Automated aliquoting systems process multiple batches of samples in parallel with consistency, ensuring clinical data remains valid.
The outcomes of scientific research studies hinge on minute details. Automated aliquoting systems streamline sample management by improving reproducibility, minimizing contamination risks, and significantly accelerating the pace of drug discovery. Drug development teams can move efficiently through their process while eliminating the variability inherent in manual pipetting. Precise aliquoting directly influences the success of drug development and lays the foundation for advancement of life-saving drugs.
At Scinomix, we strive to simplify lab processes while ensuring top-quality results. Our innovative solutions in laboratory automation continue to eliminate repetitive and tedious tasks. By automating lab processes using efficient benchtop solutions, we help to free valuable time and resources, allowing researchers to focus on groundbreaking discoveries. We understand that data accuracy and quality are essential for scientific progress, and that is why we are dedicated to providing automation solutions that guarantee reliable and accurate results. With Scinomix, you can expect lab automation that simplifies processes and ensures quality results every time.
Learn how Scinomix’s all-in-one benchtop laboratory automation system benefits the drug discovery research process.