Review ArticleReview
PCMO L01—Setting Specifications for Biological Investigational Medicinal Products
Stephan O. Krause
PDA Journal of Pharmaceutical Science and Technology September 2015, 69 (5) 569-589; DOI: https://doi.org/10.5731/pdajpst.2015.01065
Stephan O. Krause
AstraZeneca Biologics, 633 Research Court, Frederick, MD 21703, USA; 301-398-2108;

References
- 1.↵ICH Guidance for Industry Q8(R2): Pharmaceutical Development.
- 2.↵ICH Guidance for Industry Q11: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities).
- 3.↵ICH Guidance for Industry Q9: Quality Risk Management.
- 4.↵ICH Guidance for Industry Q10: Pharmaceutical Quality System.
- 5.↵ICH Guidance for Industry Q6B: Specifications: Test Procedures and Acceptance Criteria.
- 6.↵A-Mab: A Case Study in Bioprocess Development, CASSS- ISPE.
- 7.↵EBE: Concept Paper, Considerations in Setting Specifications, 28 March 2013.
- 8.↵
- 9.↵EudraLex. The Rules Governing Medicinal Products in the European Union, Volume 4. EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use. Annex 13.
- 10.↵
- Rathore A. S.,
- Mhatre R.
- Schenerman M. A.,
- Axley M. J.,
- Oliver C. N.,
- Ram K.,
- Wasserman G. F.
- 11.↵
- Krause S.
- 12.↵
- Krause S.
- 13.↵PDA Technical Report 57. Analytical Method Validation and Transfer for Biotechnology Products, 2012.
- 14.↵
- Krause S
- 15.↵EMA, Report of the Expert Workshop on Setting Specifications for Biotech Products, London, 09 September 2011.
- 16.↵Ph. Eur. Monograph on Monoclonal Antibodies for Human Use, 2013.
- 17.↵
- Griffiths E
- 18.↵USP <61> Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests.
- 19.↵USP <85> Bacterial Endotoxins Test.
- 20.↵EP 2.9.19 Particulate Contamination: Sub-visible Particles and USP <788> Particulate Matter in Injections.
- 21.↵USP <1> Injections.
- 22.↵EP 2.9.17. Test for Extractable Volume of Parenteral Preparations.
- 23.↵USP <71> Sterility Tests.
- 24.↵
- Mire-Sluis A.,
- Frazier M.,
- May K.,
- Lacana E.,
- Green N.,
- Dye E.,
- Krause S.,
- Shacter E.,
- Reischl I.,
- Deshpande R,
- Kutza J.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 69, Issue 5
September/October 2015
PCMO L01—Setting Specifications for Biological Investigational Medicinal Products
Stephan O. Krause
PDA Journal of Pharmaceutical Science and Technology Sep 2015, 69 (5) 569-589; DOI: 10.5731/pdajpst.2015.01065
Jump to section
- Article
- Abstract
- 1. Introduction and Scope
- Abbreviations
- 2. Control Strategy
- 3. Setting and Justification of Specifications During Product Development
- 4. Typical DS and DP Specification Revision and Justification Examples
- 5. Case Study for Product Imp Specification Setting Process
- 6. Discussion
- Including Statistical Uncertainty
- Conflict of Interest Declaration
- Footnotes
- References
- Figures & Data
- References
- Info & Metrics
Related Articles
- No related articles found.