Advertisement

Journal of Pharmaceutical Innovation

, Volume 12, Issue 4, pp 357–366 | Cite as

A Risk-Based Approach to Setting Acceptance Criteria for Pharmaceutical Process Comparability

  • Binbing YuEmail author
  • Lingmin Zeng
  • Harry Yang
Original Article
  • 292 Downloads

Abstract

Purpose

Throughout the life cycle of a biotechnological drug product, changes and improvements of manufacturing processes are common. It is required by the regulatory bodies that manufacturers establish adequate and appropriate comparability between pre-change and post-change products. The goals of comparability assessments are to demonstrate the comparability and consistency of product quality before and after change and to demonstrate that the changes do not have an adverse effect on safety and efficacy of the drug products.

Methods

A well-planned and detailed comparability protocol may facilitate the approval of process changes and expedite the production and distribution of lifesaving drug products to patients. Analytical comparability is the foundation of all comparability exercise. Therefore, a sound comparability protocol should carefully select relevant critical quality attributes, prepare a flexible testing plan, and predefine appropriate acceptance criteria. Selection of analytical methods and acceptance criteria for determining comparability may be the most challenging step in the comparability study.

Results

In this article, a risk-based approach is proposed to setting the acceptance criteria for analytical comparability during the pharmaceutical process change. The proposed method is applied to a late-phase process comparability study, illustrating the value of using prior information and historical data.

Conclusion

The Bayesian methodology allows the manufacturer to utilize accumulated scientific knowledge and manufacture experience during the life cycle of pharmaceutical development and the risk assessment enables control of the probability of out-of-specification, thus protecting the patients’ risks.

Keywords

Acceptance criteria Bayesian method Comparability Process change Quality attributes 

Notes

Acknowledgements

The authors would like to thank Dr. Rick Burdick for his helpful comments and suggestions, which greatly helped improve the paper.

References

  1. 1.
    Towns J, Webber K. Demonstrating comparability for well-characterized biotechnology products early phase, late phase, and postapproval. BioProcess Int. 2008;32–43.Google Scholar
  2. 2.
    ICH. Comparability of biotechnological/biological products subject to changes in their manufacturing process Q5E November 2004. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q5E/Step4/Q5E_Guideline.pdf.
  3. 3.
    EMEA. EMEA Guideline on comparability of medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. 2003.Google Scholar
  4. 4.
    US FDA. Draft guidance for industry, comparability protocols—chemistry, manufacturing, and controls information. 2003. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070545.pdf.
  5. 5.
    US FDA. Draft guidance for industry, established conditions: reportable CMC changes for approved drug and biologic products. 2015. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm448638.pdf .
  6. 6.
    US FDA. Guidance for industry, comparability protocols - chemistry, manufacturing, and controls information for new animal drugs. 2016. http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/ucm052510.pdf.
  7. 7.
    US FDA. Draft guidance for industry, comparability protocols for human drugs and biologics: chemistry, manufacturing, and controls information. 2016. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM496611.pdf.
  8. 8.
    Chirino AJ, Mire-Sluis A. Characterizing biological products and assessing comparability following manufacturing changes. Nat Biotechnol 2004;22(11):1383–91.CrossRefPubMedGoogle Scholar
  9. 9.
    Lubiniecki A, Volkin DB, Federici M, Bond MD, Nedved ML, Hendricks L, Mehndiratta P, Bruner M, Burman S, DalMonte P, et al. Comparability assessments of process and product changes made during development of two different monoclonal antibodies. Biologicals 2011;39(1):9–22.CrossRefPubMedGoogle Scholar
  10. 10.
    Schlegel M, Bobinnec Y. Comparability protocols for biotechnological products, a five-step methodology. BioProcess Int. 2013;11:30–41.Google Scholar
  11. 11.
    Limentani GB, Ringo MC, Ye F, Bergquist ML, MCSorley EO. Beyond the t-test: statistical equivalence testing. Anal Chem 2005;77(11):221–A.CrossRefGoogle Scholar
  12. 12.
    Hauck W, DeStefano A, Cecil T, Abernethy D, Koch W, Williams R. Acceptable, equivalent, or better: approaches for alternatives to official compendial procedures. Pharmacop Forum 2009;35:772–8.Google Scholar
  13. 13.
    Chambers D, Kelly G, Limentani G, Lister A, Lung KR, Warner E. Analytical method equivalency. Pharm Technol 2005;29:64 –80.Google Scholar
  14. 14.
    Abdel-Kader H, Argentine M, Hofer J, Benz N, Burdick R, Chatfield M, Diana F, Fang H, Huang Y, Karmarkar S, Nair LM, Natishan T, Pless AM, Wang Q, Williams Z. Analytical method comparability in registration and post-approval stages: a risk-based approach. Pharm Technol Eur. 2014;26(10):47–53.Google Scholar
  15. 15.
    Chatfield MJ, Borman PJ. Acceptance criteria for method equivalency assessments. Anal Chem 2009;81 (24):9841–8.CrossRefPubMedGoogle Scholar
  16. 16.
    de Fontenay G. Analytical method transfer: new descriptive approach for acceptance criteria definition. J Pharm Biomed Anal 2008;46(1):104–12.CrossRefPubMedGoogle Scholar
  17. 17.
    Chatfield MJ, Borman PJ, Damjanov I. Evaluating change during pharmaceutical product development and manufacture–comparability and equivalence. Qual Reliab Eng Int 2011;27(5):629–40.CrossRefGoogle Scholar
  18. 18.
  19. 19.
    USP. General chapter < 1010 > analytical data—interpretation and treatment.Google Scholar
  20. 20.
    Gsponer T. Equivalence testing: establishment of evidence based equivalence limits September 2013. http://www.bebpa.org/wp-content/uploads/2013/10/5_T-Gsponer.pdf.
  21. 21.
    Gelman A, Carlin J, Stern H, Rubin D. Bayesian data analysis, 2nd edn. London: Chapman and Hall; 2003.Google Scholar
  22. 22.
    Allen PV, Dukes GR, Gerger ME. Determination of release limits: a general methodology. Pharm Res 1991;8(9):1210–3.CrossRefPubMedGoogle Scholar
  23. 23.
    Wei GC. Simple methods for determination of the release limits for drug products. J Biopharm Stat 1998;8 (1):103–14.CrossRefPubMedGoogle Scholar
  24. 24.
    Lunn DJ, Thomas A, Best N, Spiegelhalter D. Winbugs-a bayesian modelling framework: concepts, structure, and extensibility. Stat Comput 2000;10(4):325–37.CrossRefGoogle Scholar
  25. 25.
    Thomas A, O’Hara B, Ligges U, Sturtz S. Making bugs open. R News 2006;6(1):12–7. http://cran.r-project.org/doc/Rnews/.Google Scholar
  26. 26.
    Phillips KF. Power of the two one-sided tests procedure in bioequivalence. J Pharmacokinet Biopharm 1990; 18(2):137–44.CrossRefPubMedGoogle Scholar
  27. 27.
    Chesher D. Evaluating assay precision. Clin Biochem Rev 2008;29(Suppl 1):S23–6.PubMedPubMedCentralGoogle Scholar
  28. 28.
    Saffaj T, Ihssane B. Uncertainty profiles for the validation of analytical methods. Talanta 2011;85(3):1535–42.CrossRefPubMedGoogle Scholar
  29. 29.
    Burdick RK, Pferdeort V, Sidor L, Tholudur A. A graphical representation for a statistical test of average equivalence and variance comparison with process data. Qual Reliab Eng Int 2011;27(6):771–80.CrossRefGoogle Scholar
  30. 30.
    Burdick RK, Sidor L. Establishment of an equivalence acceptance criterion for accelerated stability studies. J Biopharm Stat 2013;23(4):730–43.CrossRefPubMedGoogle Scholar
  31. 31.
    Boulanger B, Rozet E, Giacoletti K. A bayesian approach to method bridging. September 2015. http://www.iabs.org/index.php/documents/conferences/2015/2nd-stats-data/41-katherine-giacoletti-arlenda/file, international Alliance for Biological Standardization Conference.
  32. 32.
    Liao JJ, Darken PF. Comparability of critical quality attributes for establishing biosimilarity. Stat Med 2013;32(3):462–9.CrossRefPubMedGoogle Scholar
  33. 33.
    Albert I, Donnet S, Guihenneuc-Jouyaux C, Low-Choy S, Mengersen K, Rousseau J, et al. Combining expert opinions in prior elicitation. Bayesian Anal 2012;7(3):503–32.CrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media, LLC 2017

Authors and Affiliations

  1. 1.Statistical SciencesMedImmune LLC, An AstraZeneca CompanyGaithersburgUSA

Personalised recommendations