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Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
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High-Throughput Process Development for Biopharmaceuticals.

Abhinav A Shukla1, Shahid Rameez2, Leslie S Wolfe2

  • 1Process Development and Manufacturing, KBI Biopharma Inc., 2 Triangle Drive, Research Triangle Park, Durham, NC, 27709, USA. ashukla@kbibiopharma.com.

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|November 15, 2017
PubMed
Summary
This summary is machine-generated.

High-throughput process development (HTPD) accelerates biopharmaceutical manufacturing by enabling parallel experiments. This review covers HTPD for cell culture, purification, and analytics, envisioning integrated approaches for faster drug development.

Keywords:
CaliperHigh throughputOctetProcess characterizationProcess developmentRapid screening and developmentTecanambr

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Area of Science:

  • Biopharmaceutical Manufacturing
  • Process Development
  • Drug Discovery Acceleration

Background:

  • Process development is critical for biopharmaceutical candidates entering clinical trials.
  • High-throughput process development (HTPD) significantly reduces development timelines.
  • HTPD is crucial for late-stage development, commercial processes, and regulatory filings.

Purpose of the Study:

  • To review the current state of HTPD methodologies.
  • To examine HTPD applications in cell culture, downstream purification, and analytical techniques.
  • To propose an integrated HTPD strategy for accelerated biopharmaceutical development.

Main Methods:

  • Review of current HTPD methodologies.
  • Analysis of HTPD applications across bioprocessing stages.
  • Conceptualization of integrated HTPD workflows.

Main Results:

  • HTPD significantly shortens biopharmaceutical process development timelines.
  • Current HTPD covers cell culture, purification, and analytics.
  • Integration of HTPD across disciplines offers substantial acceleration.

Conclusions:

  • HTPD is a key enabler for rapid biopharmaceutical development.
  • Integrated HTPD strategies can create a powerful process development engine.
  • Accelerated development through HTPD facilitates faster drug candidate progression.