Critical Quality Attributes for Biotechnology Products: A Regulatory Perspective
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1 Critical Quality Attributes for Biotechnology Products: A Regulatory Perspective Patrick G. Swann, Ph.D. Deputy Director Division of Monoclonal Antibodies Office of Biotechnology Products Office of Pharmaceutical Science FDA-CDER Content reflects the views of the speaker and should not be used in lieu of regulations, published FDA guidances or direct discussions with the agency 1
2 Definition Critical Quality Attribute (Q8R2, 2009) A physical, chemical, biological or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality. 2
3 CQAs and Specifications ICH Q6B Specifications Appearance & Description Identity Purity & Impurities Potency Quantity General Tests Acceptance Criteria Numerical limits, ranges, or other suitable measures for acceptance of the results of analytical procedures which the drug substance or drug product or materials at other 3 stages of their manufacture should meet.
4 Using QRM to Identify CQAs Q9, Annex II Potential Applications of Quality Risk Management II.3 Quality Risk Management as Part of Development To design a quality product and its manufacturing process to consistently deliver the intended performance of the product (see ICH Q8) To assess critical attributes of raw materials, solvents, active pharmaceutical ingredient (API) starting materials, APIs, excipients, or packaging materials 4
5 Risk Assessment Occurrence Equal Risk? Severity Decision criteria to include Severity Alone in addition to S x O? What is referenced by occurrence? (See next slide) Complex quantitative models may convey a level of precision and understanding 5 about the system that is unjustified. (Claycamp, 2004)
6 CQAs and Probability: P1, P2 or P3? Hazard: The potential source of harm Hazardous Situation Harm: Damage to health, including the damage that can occur from loss of product quality or availability. P1 P2 P3? Severity of Harm Probability of Occurrence of Harm P1 x P2 RISK 6
7 CQAs and Risk Review 7 PDA TR44 Application of QRM to Aseptic Processing
8 CQAs and Lifecycle ICH Q6B: New analytical technology and modifications to existing technology are continually being developed and should be utilized when appropriate. 8
9 CQAs and Pilot Applications Most have included safety/efficacy impact as relates to Safety (± Toxicity) Efficacy (± Biological activity) PK (±PD) Immunogenicity Should process capability be considered when categorizing attributes? What level of confidence / type of study is needed to identify an attribute as non-critical or to set limits on CQAs? 9
10 pyro-e D O O G (9600) Attributes & Combinatorics D D G K K D D G G O O pyro-e D Pyro-Glu (2) Deamidation (3 x 2) Methionine oxidation (2 x 2) Glycation (2 x 2) High mannose, G0, G1, G1, G2 (5) Sialylation (5) C-term Lys (2) 2 x 6 x 4 x 4 x 5 x 5 x 2 =
11 Biological Activity Matrix One to some lots Many lots Multiple Binding/Cellular Assays Small Animal/Complex Bioassay Clinical Pharmacology (PK/PD) Clinical Studies Validated Bioassay 11 Clinical Lots Clinical Lot Extremes Purified/Induced Variants Stressed Lots Developmental Lots
12 Biological Activity Matrix (v.1.1) One to Some Lots Many Lots Clinical Lots Clinical Lot Extremes Purified Variants Stressed Lots Developmental Lots Clinical Studies Clinical Pharm. (PK/PD) Animal Studies / Complex Bioassay Multiple Binding Cellular Assays Validated Bioassay
13 Biological Activity Matrix (v.2.0) One to Some Lots Many Lots Clinical Lots Clin. (?) Lot Extremes Purified Variants Stressed Lots Developmental Lots Clinical Studies Clinical Pharm. (PK/PD) Animal Studies / Complex Bioassay Multiple Binding Cellular Assays Validated Bioassay
14 Biological Activity Matrix (v.2.0) One to Some Lots Many Lots Clinical Lots Clin. (?) Lot Extremes Purified Variants Stressed Lots Developmental Lots Clinical Studies Clinical Pharm. (PK/PD) Animal Studies / Complex Bioassay Multiple Binding Cellular Assays Validated Bioassay
15 Biological Activity Matrix (v.2.0) One to Some Lots Many Lots Clinical Lots Clin. (?) Lot Extremes Purified Variants Stressed Lots Developmental Lots Clinical Studies Clinical Pharm. (PK/PD) Animal Studies / Complex Bioassay Multiple Binding Cellular Assays Validated Bioassay 15
16 Product-Related Variants: Substances or Impurities? Clinical Studies Clin. (?) Lot Extremes Purified Variants ICH Q6B: Critical quality attributes may include the nature and quantity of product-related substances, product-related impurities, Clinical Pharm. (PK/PD) Animal Studies / Complex Bioassay Product-related substances. Variants of the desired product that have properties comparable to those of the desired product with respect to activity, efficacy and safety Multiple Binding Cellular Assays Validated Bioassay Product-related impurities do not have properties comparable to those of the desired product with respect to activity, efficacy, and safety. 16
17 Considerations for Studies to Characterize Variants and Set Limits: Can we use Q5e concepts? Clinical Studies Clin. (?) Lot Extremes Purified Variants ICH Q5e: The extent and nature of nonclinical and clinical studies needed to assess comparability will be determined on a case-by-case basis in consideration of various factors : Clinical Pharm. (PK/PD) Animal Studies / Complex Bioassay Multiple Binding Cellular Assays Validated Bioassay 17
18 Considerations for Studies to Characterize Variants and Set Limits: Can we use Q5e concepts? Clinical Studies Clin. (?) Lot Extremes Purified Variants The extent and nature of nonclinical and clinical studies needed to categorize variants and set limits will be determined on a case-by-case basis in consideration of various factors: Clinical Pharm. (PK/PD) Animal Studies / Complex Bioassay Multiple Binding Cellular Assays Validated Bioassay 18
19 Considerations for Studies to Characterize Variants and Set Limits: Can we use Q5e concepts? Clinical Studies Clin. (?) Lot Extremes Purified Variants The extent and nature of nonclinical and clinical studies needed to categorize variants and set limits will be determined on a case-by-case basis in consideration of various factors: Clinical Pharm. (PK/PD) Limitations of tests Animal Studies / Complex Bioassay Multiple Binding Cellular Assays Validated Bioassay 19
20 Considerations for Studies to Characterize Variants and Set Limits: Can we use Q5e concepts? Clinical Studies Clin. (?) Lot Extremes Purified Variants The extent and nature of nonclinical and clinical studies needed to categorize variants and set limits will be determined on a case-by-case basis in consideration of various factors: Clinical Pharm. (PK/PD) Animal Studies / Complex Bioassay Product complexity, Including heterogeneity Multiple Binding Cellular Assays Validated Bioassay 20
21 Considerations for Studies to Characterize Variants and Set Limits: Can we use Q5e concepts? Clinical Studies Clin. (?) Lot Extremes Purified Variants The extent and nature of nonclinical and clinical studies needed to categorize variants and set limits will be determined on a case-by-case basis in consideration of various factors: Clinical Pharm. (PK/PD) Animal Studies / Complex Bioassay Multiple Binding Cellular Assays Validated Bioassay Strength of association of quality attributes and safety/efficacy Mode(s) of action (unk. vs known; single vs. multiple active sites 21
22 Clinical Pharmacology Studies to Assess Variants Clinical Studies Clinical Pharm. (PK/PD) Clinical Lot Extremes Purified Variants The effect of Fc glycan forms on Human IgG2 antibody clearance In humans Chen, Liu, and Flynn, Glycobiology, 2009 Mar; 19 (3):240-9 human IgG2 was affinity purified In a single step from serum samples from a human pharmacokinetic study Animal Studies / Complex Bioassay Multiple Binding Cellular Assays Validated Bioassay 22
23 Summary Need to use QbD terms carefully QRM tools can be used to identify/rank CQAs but beware over interpretation ICH Q5e concepts may be of utility when considering the types of studies needed to identify/rank attributes 23
24 Acknowledgements Steven Kozlowski Kathleen Clouse Other colleagues in the Office of Biotechnology Products Authors of cited papers Presentations from Industry and FDA 24
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