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Review ArticleReview

Using Analytical Platform Technologies to Support Accelerated Product Development—Concept Review and Case Study

Stephan O. Krause
PDA Journal of Pharmaceutical Science and Technology May 2022, 76 (3) 248-262; DOI: https://doi.org/10.5731/pdajpst.2021.012647
Stephan O. Krause
AstraZeneca Biologics, Gaithersburg, MD
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References

  1. 1.↵
    U.S. Food and Drug Administration, Guidance for Industry: Expedited Programs for Serious Conditions—Drugs and Biologics. Center for Biologics Evaluation and Research. U.S. Department of Health and Human Services: Rockville, MD, 2014.
  2. 2.↵
    1. Mire-Sluis A.,
    2. Frazier M.,
    3. May K.,
    4. Lacana L.,
    5. Green N.,
    6. Dye E.,
    7. Krause S.,
    8. Shacter E.,
    9. Reischl I.,
    10. Deshpande R.,
    11. Kutza J.
    Accelerated Product Development: Leveraging Industry and Regulator Knowledge to Bring Products to Patients Quickly. BioProcess Int. 2014, 12.
  3. 3.↵
    1. Krause S.
    Risk-Based Analytical Lifecycle Steps for Accelerated Products. CASSS CMC Strategy Meeting, Washington, DC, 2014.
  4. 4.↵
    1. Krause S.
    Risk-Based Analytical Lifecycle Steps for Accelerated Products. CASSS CMC Strategy Meeting, Tokyo, Japan, 2014.
  5. 5.↵
    1. Krause S.
    Specifications and Analytical Method Lifecycle for Accelerated Biologics. Presentation to CDER/OBP, White Oak, MD, September 28, 2015.
  6. 6.↵
    1. Krause S.
    Reducing Analytical Method Lifecycle Steps for Accelerated Products. PDA Letter April 2016.
  7. 7.↵
    1. Krause S.
    An Industry Perspective for Analytical Method Validation and Transfer for Biotechnology Product. Presentation to CDER/OBP, NIH Campus, MD, 2012.
  8. 8.↵
    Parenteral Drug Association Inc. Technical Report No. 57: Analytical Method Validation and Transfer for Biotechnology Products; Bethesda, MD, 2012.
  9. 9.↵
    International Conference for Harmonisation, Guidance for Industry Q2(R1): Validation of Analytical Procedures: Text and Methodology. ICH: Geneva, 2005.
  10. 10.↵
    Parenteral Drug Association Inc. Technical Report No. 57-2: Analytical Method Development and Qualification for Biotechnology Products; Bethesda, MD, 2015.
  11. 11.↵
    NIST Monoclonal Antibody Reference Material 8671. NIST Web site. https://www.nist.gov/programs-projects/nist-monoclonal-antibody-reference-material-8671 (accessed December 15, 2021).
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 76 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 76, Issue 3
May/June 2022
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Using Analytical Platform Technologies to Support Accelerated Product Development—Concept Review and Case Study
Stephan O. Krause
PDA Journal of Pharmaceutical Science and Technology May 2022, 76 (3) 248-262; DOI: 10.5731/pdajpst.2021.012647

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Using Analytical Platform Technologies to Support Accelerated Product Development—Concept Review and Case Study
Stephan O. Krause
PDA Journal of Pharmaceutical Science and Technology May 2022, 76 (3) 248-262; DOI: 10.5731/pdajpst.2021.012647
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  • Article
    • Abstract
    • 1. Introduction and Scope
    • 2. Risk-Based Validation Concepts
    • 3. Accelerated Product Development
    • 4. APT Concept and Use Conditions
    • 5. HPSEC Case Study
    • 6. Discussion
    • 7. Conclusion
    • Conflict of Interest Declaration
    • Acknowledgement
    • Footnotes
    • References
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  • A Review of Artificial Intelligence and Machine Learning in Product Life Cycle Management
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Keywords

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