OSD

Many aspects of oral solid dose (OSD) drug development have been constantly evolving in recent years as companies strive to bring more innovative drugs to market.

However, navigating these changes comes with various challenges, including cost pressures and demands to reduce timelines, as well as the inherent scientific hurdles that accompany product development and preparing for robust clinical and commercial manufacturing.

To overcome these obstacles, pharmaceutical companies must explore more comprehensive and innovative analytical development strategies.

Fortunately, the latest advancements are set to make a significant impact in 2024, offering manufacturers better ways to streamline the path to OSD success. These include:

  • Strategies for complex formulations and analytical development: One of the primary challenges in drug development lies in the formulation of complex drugs such as biologics and combination therapies. These formulations require tailored analytical methods to ensure safety, efficacy and quality. Comprehensive analytical development strategies that encompass a wide range of techniques, such as modified phenotypic assays, new screening models and label-free technologies, are essential to analyse and characterise these complex formulations effectively.
  • Advancements in technology: The pharmaceutical industry is witnessing remarkable advancements in technology that are revolutionising drug development. Automation, robotic systems, data analytics and artificial intelligence are playing pivotal roles in expediting the drug discovery and development processes. These technologies optimise manufacturing processes, aid in patient identification for clinical trials and enhance the efficiency of data analysis, leading to better decision-making.
  • Harnessing the power of data science: Data science is becoming increasingly important in addressing OSD development challenges such as tech transfer and scaling. It continues to influence all aspects of drug production, from in silico development to facility planning and quality assurance. In routine production, data science reduces deviations, optimises planning and enables expedited timelines, ensuring vital medicines reach patients sooner.
  • Regulatory compliance and cybersecurity: As drug development becomes more complex, regulatory bodies are adapting their guidelines to ensure patient safety and efficacy. Compliance with evolving regulations is crucial for pharmaceutical companies to bring their products to market. Additionally, with the increasing reliance on digital platforms, cybersecurity is of paramount importance. Pharmaceutical companies must implement robust cybersecurity measures to protect sensitive patient data and maintain the integrity of their research.
  • Specialised technologies for in-depth testing: Specialised analytical techniques, such as inductively coupled plasma optical emission spectroscopy (ICP-OES), are gaining prominence in drug development. These techniques allow for in-depth testing and analysis, ensuring compliance with regulatory standards and the detection of trace impurities. By leveraging such technologies, pharmaceutical companies can enhance their quality control processes and provide safer and more effective drugs to patients.

 

Our experts recently shared their insights in a series of commentaries on the latest developments in the OSD space. Dive into them below to discover what we can expect from technological advancements in streamlining the journey to market in 2024 and beyond.

 

References:

https://www.worldpharmatoday.com/articles/the-broad-pharma-chain-2023-o…

https://www.lskh.digital/article/cphi-barcelona-round-table-discussion/

https://pharmaceuticalmanufacturer.media/pharma-manufacturing-news/late…