Analytical Elements of Module 3 for Biopharmaceutical ... · 4. Qualification of All Test Methods (e.g. establish linearity, precision, accuracy, specificity, etc…) 5. Validation
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
3/29/2019
1
Analytical Elements of Module 3 for Biopharmaceutical Products: Beyond S.4 and P.5
Nadine M. Ritter, Ph.D.President and Sr. Analytical Advisor
CMC Analytical Data Packages =The Biomolecular “Story” of Each Rhino
1. Compositional, Conformational and Functional Characterization of Target Protein2. Characterization of Impurities (Product Impurities and Process Residuals)
CMC Analytical Data Packages =The Biomolecular “Story” of Each Rhino
1. Compositional, Conformational and Functional Characterization of Target Protein2. Characterization of Impurities (Product Impurities and Process Residuals)3. Establishment and Bridging of Product Reference Standards
CMC Analytical Data Packages =The Biomolecular “Story” of Each Rhino
1. Compositional, Conformational and Functional Characterization of Target Protein2. Characterization of Impurities (Product Impurities and Process Residuals)3. Establishment and Bridging of Product Reference Standards4. Qualification of All Test Methods (e.g. establish linearity, precision, accuracy,
CMC Analytical Data Packages =The Biomolecular “Story” of Each Rhino
1. Compositional, Conformational and Functional Characterization of Target Protein2. Characterization of Impurities (Product Impurities and Process Residuals)3. Establishment and Bridging of Product Reference Standards4. Qualification of All Test Methods (e.g. establish linearity, precision, accuracy,
specificity, etc…)5. Validation of cGMP Test Methods (e.g. confirmation of above parameters, plus
addition of data for method robustness and stability‐indicating capability)
CMC Analytical Data Packages =The Biomolecular “Story” of Each Rhino
1. Compositional, Conformational and Functional Characterization of Target Protein2. Characterization of Impurities (Product Impurities and Process Residuals)3. Establishment and Bridging of Product Reference Standards4. Qualification of All Test Methods (e.g. establish linearity, precision, accuracy,
specificity, etc…)5. Validation of cGMP Test Methods (e.g. confirmation of above parameters, plus
addition of data for method robustness and stability‐indicating capability)6. DP Formulation development (excipient selection, formulation stability)
CMC Analytical Data Packages =The Biomolecular “Story” of Each Rhino
1. Compositional, Conformational and Functional Characterization of Target Protein2. Characterization of Impurities (Product Impurities and Process Residuals)3. Establishment and Bridging of Product Reference Standards4. Qualification of All Test Methods (e.g. establish linearity, precision, accuracy,
specificity, etc…)5. Validation of cGMP Test Methods (e.g. confirmation of above parameters, plus
addition of data for method robustness and stability‐indicating capability)6. DP Formulation development (excipient selection, formulation stability)7. DS and DP Batch release data (manufacturing consistency and product quality)
CMC Analytical Data Packages =The Biomolecular “Story” of Each Rhino
1. Compositional, Conformational and Functional Characterization of Target Protein2. Characterization of Impurities (Product Impurities and Process Residuals)3. Establishment and Bridging of Product Reference Standards4. Qualification of All Test Methods (e.g. establish linearity, precision, accuracy,
specificity, etc…)5. Validation of cGMP Test Methods (e.g. confirmation of above parameters, plus
addition of data for method robustness and stability‐indicating capability)6. DP Formulation development (excipient selection, formulation stability)7. DS and DP Batch release data (manufacturing consistency and product quality)8. Extractable and Leachable Studies (risk assessment for DS; confirmation for DP)
CMC Analytical Data Packages =The Biomolecular “Story” of Each Rhino
1. Compositional, Conformational and Functional Characterization of Target Protein2. Characterization of Impurities (Product Impurities and Process Residuals)3. Establishment and Bridging of Product Reference Standards4. Qualification of All Test Methods (e.g. establish linearity, precision, accuracy,
specificity, etc…)5. Validation of cGMP Test Methods (e.g. confirmation of above parameters, plus
addition of data for method robustness and stability‐indicating capability)6. DP Formulation development (excipient selection, formulation stability)7. DS and DP Batch release data (manufacturing consistency and product quality)8. Extractable and Leachable Studies (risk assessment for DS; confirmation for DP)9. Degradation evaluation (establishment of stability profile, validate stability
CMC Analytical Data Packages =The Biomolecular “Story” of Each Rhino
1. Compositional, Conformational and Functional Characterization of Target Protein2. Characterization of Impurities (Product Impurities and Process Residuals)3. Establishment and Bridging of Product Reference Standards4. Qualification of All Test Methods (e.g. establish linearity, precision, accuracy,
specificity, etc…)5. Validation of cGMP Test Methods (e.g. confirmation of above parameters, plus
addition of data for method robustness and stability‐indicating capability)6. DP Formulation development (excipient selection, formulation stability)7. DS and DP Batch release data (manufacturing consistency and product quality)8. Extractable and Leachable Studies (risk assessment for DS; confirmation for DP)9. Degradation evaluation (establishment of stability profile, validate stability
methods, characterize degradants, assess comparability/similarity)10. ICH Stability testing (accelerated and ongoing real‐time/real conditions)
CMC Analytical Data Packages =The Biomolecular “Story” of Each Rhino
1. Compositional, Conformational and Functional Characterization of Target Protein2. Characterization of Impurities (Product Impurities and Process Residuals)3. Establishment and Bridging of Product Reference Standards4. Qualification of All Test Methods (e.g. establish linearity, precision, accuracy,
specificity, etc…)5. Validation of cGMP Test Methods (e.g. confirmation of above parameters, plus
addition of data for method robustness and stability‐indicating capability)6. DP Formulation development (excipient selection, formulation stability)7. DS and DP Batch release data (manufacturing consistency and product quality)8. Extractable and Leachable Studies (risk assessment for DS; confirmation for DP)9. Degradation evaluation (establishment of stability profile, validate stability
methods, characterize degradants, assess comparability/similarity)10. ICH Stability testing (accelerated and ongoing real‐time/real conditions)11. DS and DP Comparability assessment (during clinical development and post‐
CMC Analytical Data Packages =The Biomolecular “Story” of Each Rhino
1. Compositional, Conformational and Functional Characterization of Target Protein2. Characterizatiompurities (Product Impurities and Process Residuals)3. Establishment and Bridging of Product Reference Standards4. Qualification of All Test Methods (e.g. establish linearity, precision, accuracy,
specificity, etc…)5. Validation of cGMP Test Methods (e.g. confirmation of above parameters, plus
addition of data for method robustness and stability‐indicating capability)6. DP Formulation development (excipient selection, formulation stability)7. DS and DP Batch release data (manufacturing consistency and product quality)8. Extractable and Leachable Studies (risk assessment for DS; confirmation for DP)9. Degradation evaluation (establishment of stability profile, validate stability
methods, characterize degradants, assess comparability/similarity)10. ICH Stability testing (accelerated and ongoing real‐time/real conditions)11. DS and DP Comparability assessment (during clinical development and post‐
approval)BIOSIMILAR PRODUCTS ONLY:12. Analytical Similarity – Comparison of Biosimilar product to Originator Product
CMC Analytical Data Packages =The Biomolecular “Story” of Each Rhino
1. Compositional, Conformational and Functional Characterization of Target Protein2. Characterization of Impurities (Product Impurities and Process Residuals)3. Establishment and Bridging of Product Reference Standards4. Qualification of All Test Methods (e.g. establish linearity, precision, accuracy,
specificity, etc…)5. Validation of cGMP Test Methods (e.g. confirmation of above parameters, plus
addition of data for method robustness and stability‐indicating capability)6. DP Formulation development (excipient selection, formulation stability)7. DS and DP Batch release data (manufacturing consistency and product quality)8. Extractable and Leachable Studies (risk assessment for DS; confirmation for DP)9. Degradation evaluation (establishment of stability profile, validate stability
methods, characterize degradants, assess comparability/similarity)10. ICH Stability testing (accelerated and ongoing real‐time/real conditions)11. DS and DP Comparability assessment (during clinical development and post‐
approval)BIOSIMILAR PRODUCTS ONLY:12. Analytical Similarity – Comparison of Biosimilar product to Originator Product
Here are the analytical data proving I am stable over time
Any additional drug substance and/or drug product information specific to each region should be provided. Consult the appropriate regional guidance and/or regulatory authorities for additional guidance.
BIOSIMILAR PRODUCTSAnalytical data packages comparing Biosimilar Product to Reference Product