The role of process development in drug discovery
Key strategies in process development
Applications in drug discovery
Commercial relevance
Summary
Designing an efficient platform is crucial for any industrial process. This design process is known as process development, and it has become increasingly important in the pharmaceutical industry at all stages of the drug discovery and design journey.
Robust process development is key to optimizing methods for drug manufacturing and testing, playing a critical role in bridging the gap between early-stage drug discovery and commercial production.
Efficient and well-designed process development accelerates drug discovery timelines, saves costs, and ensures higher-quality clinical and commercial outcomes. Moreover, it can help maintain regulatory compliance and improve the quality of pharmaceutical products.1 This article will explore this subject.
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The role of process development in drug discovery
Designing robust production methods can often be a rate-limiting factor in drug design and development.2 A clear approach is therefore necessary to provide the benefits of process development for clinical research teams, pharma companies, and, most importantly, patients.
Process development strategies provide multiple benefits across all stages of the drug design and development process, from initial discovery to regulatory approval and market release.
Many researchers in recent years have highlighted the need for standardized process development strategies that can streamline workflows in the drug development laboratory from initial compound screening to clinical trials. Speed is an important consideration in the process development process, as this can save money and improve the efficiency of introducing therapeutic targets into clinical trials.2
A generic, templated approach can greatly reduce the resources and time allocated to process development in the pharma industry. This approach also needs to be flexible enough to be relevant for the myriad of therapeutic targets and the diverse clinical conditions and diseases they are intended to treat.
Furthermore, a robust and streamlined process development strategy provides benefits to scalability, allowing drug development to transition seamlessly from small-scale laboratory studies to industrial-scale production of the final therapeutic product.
Another vitally important part of the drug development process is ensuring consistency and regulatory compliance. The results of clinical trials must be reproducible for a drug to meet stringent regulatory and quality standards, and streamlined, data-driven processes can help researchers and companies achieve this.
The Drug Discovery Process
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Key strategies in process development
Several key strategies are employed in pharmaceutical process development. Recent process development efforts in multiple research projects in the pharma industry have significantly improved the drug development process.
Chemists have improved and refined synthetic pathways in drug discovery and development, increasing yields, reducing waste, and enhancing efficiency. As a result, new drugs are brought to market more quickly than in previous decades.
Emerging technologies and processes in bioprocess engineering have also had an impact on the drug development process. Cell line development, advanced bioreactors, and fermentation technologies have all become central elements of pharma research. Micro bioreactors, for instance, can streamline cell line evaluation and upstream development.3
Advanced analytical techniques are also employed in process development. The main benefits of these techniques are ensuring the purity, stability, and performance of drug candidates. This helps to streamline the drug discovery process, saving costs and resources and ensuring that drug candidates become viable pharmaceutical products at the end of the process.
Additionally, emerging Industry 4.0 technologies such as AI, machine learning, robotics, automation, and data-driven simulations and computer models are accelerating process optimization in the pharmaceutical industry. Indeed, AI and machine learning have emerged as indispensable tools, unraveling complex and intricate factors such as the kinetics of synthesis routes.4
AI and ML’s ability to “learn” from streams of clinical data improves the efficiency and speed of the drug discovery process. Robotics and automation can work more efficiently and around the clock, saving resources and time and optimizing the drug development process. Why these emerging technologies have become indispensable process development tools can clearly be seen.
Applications in drug discovery
As can be seen, process development is becoming an increasingly central part of drug discovery and development, providing benefits across multiple stages of the journey.
In early-stage development, for example, this approach aids in the identification of viable candidate molecules, optimizing their chemical and physical properties. During preclinical and clinical trial phases, process development ensures sufficient drug supply and compliance. Finally, ensuring the consistent production of high-quality and safe market-ready drugs is crucial for their commercialization.
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Commercial relevance
Optimizing the production process by leveraging tools such as AI, bioreactors, and powerful analytical tools gives pharmaceutical companies a competitive edge and reduces waste, costs, resources, and time.
Drug development timelines are traditionally slow and sluggish, and by streamlining drug manufacturing processes, drugs, and therapeutics can be brought to the market much faster.
This gives companies clear economic advantages over their competitors. Pharmaceutical development has notoriously low margins and profits. Therefore, any resource, time, and cost savings made possible by robust production process optimization translate positively to a more favorable economic environment for a pharma company.
Furthermore, by ensuring regulatory compliance, process development strategies give pharma companies an extra competitive and economic advantage be improving adherence to GMP (Good Manufacturing Processes) standards and traditionally complex regulatory frameworks.
In Summary
In summary, process development can provide significant benefits for drug discovery and development. Target molecules can be identified faster and, therefore, enter the preclinical and clinical trial stages sooner. Scalability can be improved.
Commercialization, quality assurance, and regulatory compliance are benefits, and robust process development gives companies a clear competitive edge.
This approach, which incorporates collaboration between different researchers and commercial enterprises and is being transformed by emerging technologies such as automation, AI, and machine learning, is transforming drug discovery outcomes, providing benefits for pharma companies and, most importantly, patients themselves.
However, the continued success of this approach in the pharmaceutical industry will depend on leveraging future innovations to meet the growing complexity of modern pharmaceuticals.
While many challenges lie ahead, multiple researchers and pharmaceutical companies have laid the groundwork for future development in this area.
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Further Reading