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Inductively coupled plasma (ICP) is the common plasma source used in atomic emission spectroscopy (AES), a technique that detects and analyzes various elements in a sample. This method is often called inductively coupled plasma atomic emission spectroscopy (ICP-AES).
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The quadrupole mass analyzer consists of four cylindrical metal rods arranged in a diamond carrying a DC voltage and a radio-frequency AC voltage. The motion of ions through the quadrupole depends on the field strength, causing only ions of a certain m/z to resonate successfully and strike the detector at a given field strength. Though the transmission rate for these analyzers is high, the exact elemental composition of the sample is not determined because of low resolution; however, they are...
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The mass analyzer is a crucial component of the mass spectrometer. In the ionization chamber, the vaporized sample is bombarded with a high-energy electron beam to generate a radical cation and further fragment into neutral molecules, radicals, and cations. A series of negatively charged accelerator plates accelerate the cations into the mass analyzer. The mass analyzer separates ions according to their mass-to-charge (m/z) ratios and then directs them to the detector. The common types of mass...
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Accelerating attribute-focused process and product development through the development and deployment of autonomous

Chao-Hsiang Richard Wu1, Becky Chan1, Zac Sarich1

  • 1Attribute Sciences, Process Development, Amgen Inc., Thousand Oaks, California, USA.

Biotechnology and Bioengineering
|February 8, 2024
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Summary

This study introduces automated systems for real-time biopharmaceutical analysis, accelerating process development and ensuring product quality. These innovations enable faster testing and release in manufacturing environments.

Keywords:
Quality by Design (QbD)automatic assay preparation platform (A2P2)micro sequential injection (µSI)process analytical technology (PAT)

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Area of Science:

  • Biopharmaceutical Manufacturing
  • Analytical Chemistry
  • Process Engineering

Background:

  • Real-time monitoring and control are crucial for biopharmaceutical manufacturing to ensure desired product quality attributes.
  • The Quality by Design (QbD) approach necessitates processes that consistently deliver high-quality products, but offline analytical testing causes delays.
  • Accelerating process development requires the deployment of advanced analytical technologies.

Purpose of the Study:

  • To develop an automated, online, real-time sample acquisition and preparation platform system for biopharmaceuticals.
  • To address the unmet need for rapid in-process monitoring, control, and product release.
  • To enable faster analytical testing in both laboratory and manufacturing settings.

Main Methods:

  • Development of a micro sequential injection process analyzer.
  • Creation of an automatic assay preparation platform system.
  • Integration of these systems for automated sample handling and analysis.

Main Results:

  • Successful development of integrated automated systems for sample acquisition and preparation.
  • Demonstration of the systems' capability for online, real-time analysis.
  • Validation of the systems for deployment in laboratory and good manufacturing practice (GMP) environments.

Conclusions:

  • The developed automated systems significantly accelerate biopharmaceutical process development and product release.
  • These innovations support an attribute-focused Quality by Design approach by providing real-time quality insights.
  • The systems offer a versatile solution for rapid analytical testing, enhancing efficiency and quality assurance in biomanufacturing.