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Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
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Understanding drugs, drug products, and their performance in pharmaceutical science is pivotal. Drugs, whether simple molecules or complex compounds, are designed to interact with the body's biological systems to diagnose, treat, or prevent diseases. Drug products include various delivery systems such as tablets, capsules, injections, and inhalers. The performance of these drug products is gauged by their ability to deliver the active ingredient to the desired site of action at the...
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Pharmacodynamic methods provide insights into a drug's effects on physiological processes over time and play a crucial role in understanding bioavailability and therapeutic efficacy. These methods can be broadly classified into acute pharmacological and therapeutic response approaches, each with distinct mechanisms and applications.The acute pharmacological response method directly correlates a drug's physiological effects, such as ECG or pupil diameter changes, to its time course in the body.
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Analysis of population pharmacokinetic data involves studying the behavior of drugs within diverse populations to understand their pharmacokinetic parameters. Traditional pharmacokinetic methods typically involve collecting samples from a few individuals and estimating these parameters. While these methods are commonly used, they have limitations in capturing the variability in drug response among individuals or heterogeneous populations. Population pharmacokinetics is employed to address these...
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Process analytics 4.0: A paradigm shift in rapid analytics for biologics development.

Dhanuka P Wasalathanthri1, Ruchir Shah1, Julia Ding1

  • 1Global Process Development Analytics, Bristol-Myers Squibb Company, Devens, Massachusetts, USA.

Biotechnology Progress
|May 26, 2021
PubMed
Summary
This summary is machine-generated.

Process Analytics 4.0 integrates advanced technologies like process analytical technology (PAT) and automation for biologics development. This framework enables real-time analytics, improving process understanding, agility, and sustainability in biopharmaceutical manufacturing.

Keywords:
automationcyber-physical systemsprocess analytical technologyprocess analytics 4.0

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Area of Science:

  • Biopharmaceutical Process Development
  • Analytical Chemistry
  • Industrial Automation

Background:

  • Biologics development faces challenges in analytical testing due to complex biomolecules.
  • There is a need for advanced process analytics tools for rapid analysis.

Purpose of the Study:

  • Introduce and define Process Analytics 4.0.
  • Review key features of PAT, automation, and data management in biologics process development.
  • Discuss business aspects and implementation challenges.

Main Methods:

  • Literature review focusing on Process Analytical Technology (PAT), assay automation, and cyber-physical systems.
  • Analysis of digitalization, automation, and real-time testing benefits.
  • Examination of robotics, liquid handling, and data management systems.

Main Results:

  • Process Analytics 4.0 combines technology (PAT, automation, IoT) with cyber-physical systems for real-time analytics.
  • Digitalization and automation offer significant technological and business advantages.
  • Robotics and automation enhance high-throughput testing capabilities.

Conclusions:

  • Systematic PAT implementation enables real-time analytics for better process understanding and sustainability.
  • Cyber-physical systems are crucial for data management within the Process Analytics 4.0 framework.
  • Implementation challenges exist but yield substantial benefits in biopharmaceutical drug substance development.