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Related Concept Videos

Development of Analytical Methods01:21

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An analytical methodology can be divided into four sequential steps: technique, method, procedure, and protocol. A technique is a scientific principle that rationalizes a specific phenomenon through chemical measurements. Adapting a technique for analyzing a sample of interest is termed a method. The procedure outlines the directions for performing the analysis via an analytical method. The protocol is the detailed guidelines on the procedure, which should be strictly followed to obtain the...
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Rational drug product design integrates knowledge of the drug’s physicochemical properties, formulation components, manufacturing techniques, and intended route of administration. Each factor influences the drug’s performance, including how it is released, absorbed, and eliminated in the body.The physicochemical properties of a drug—such as solubility, stability, and particle size—affect its compatibility with excipients and the choice of dosage form. Excipients, though...
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Drug discovery is a multifaceted process involving extensive screening, testing, and optimization of lead compounds to identify potential new drugs for therapeutic use. It combines several approaches, including screening large numbers of natural products, chemical modification of known active molecules, identification of new drug targets, and rational design based on biological mechanisms and drug-receptor structure. These approaches are carried out in both academic research laboratories and...
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In vitro dissolution and drug release tests assess how quickly and how much of a drug is released from its dosage form into an aqueous medium under standardized laboratory conditions. These tests are essential tools in pharmaceutical development and quality assurance, offering insight into the drug's performance before clinical use.During formulation development, dissolution testing identifies incomplete or inconsistent drug release issues. It also supports decisions on selecting the optimal...
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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Using Analytical Platform Technologies to Support Accelerated Product Development-Concept Review and Case Study.

Stephan O Krause1

  • 1AstraZeneca Biologics, Gaithersburg, MD Stephan.Krause@astrazeneca.com.

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|October 19, 2021
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Summary
This summary is machine-generated.

Analytical platform technologies (APT) can streamline biological product development. This approach reduces analytical life cycle steps, accelerating the delivery of critical medicines through efficient chemistry, manufacturing, and controls (CMC).

Keywords:
AnalyticalCMCDevelopment AccelerationPlatform TechnologyQualityRegulatoryValidation

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Area of Science:

  • Biopharmaceutical development
  • Analytical chemistry
  • Regulatory science

Background:

  • Increasing number of biological products for serious conditions eligible for expedited development programs.
  • Need for efficient strategies to support accelerated drug development timelines.

Purpose of the Study:

  • To present an industry perspective on reducing analytical life cycle steps using analytical platform technologies (APT).
  • To support accelerated biological product development and associated Chemistry, Manufacturing, and Control (CMC) processes.

Main Methods:

  • Conceptual review of life cycle strategies for APT methods within the CMC acceleration framework.
  • Detailed case study illustrating initial method validation and subsequent APT verification.
  • Discussion of APT implementation considerations.

Main Results:

  • Reduced method qualification, transfer, and validation studies are feasible if the initial test method remains unchanged.
  • A case study demonstrates practical considerations for APT validation and verification.
  • Guidance on submitting APT information in regulatory filings is provided.

Conclusions:

  • APT offers a viable strategy to reduce analytical life cycle burdens in accelerated biological product development.
  • Careful initial method validation and subsequent verification are key to successful APT implementation.
  • Streamlined analytical processes using APT can expedite the availability of important therapies.