Workshop on process validation

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1 Workshop on process validation CMC Strategy Forum Europe 2013 EBE Process validation satellite session Pragues, 06/05/2013 Kowid Ho

2 Scope / background Process evaluation/validation of biotechnology derived proteins used as active substance in the manufacture of medicinal products (i.e. scope of Q6B) Address data requirement for process validation/evaluation for submission of a marketing authorisation application or variation. Process Validation can be based on a traditional or enhanced approach to process development. Traditional and enhanced approaches are not mutually exclusive. A company can use either a traditional approach or an enhanced approach to process validation, or a combination of both. 1

3 Process validation biotech drug substance General concepts Objective: To establish scientific evidence that a process is capable of consistently delivering a quality drug substance. Will justify the manufacturing process described in S2.2 More consistency in data submission and assessment Data expected: Process evaluation (small and/or full scale) Process verification (full scale) or continous process verification +/- Continued process verification 2

4 Process evaluation Process evaluation studies: should provide evidence that, when operating in accordance with conditions described in process description, the complete manufacturing process and each step/operating unit have been appropriately designed to obtain a product of the intended quality. should include the evaluation of the ability of each step to obtain output of desired quality at small and/or full scale as appropriate. the results, demonstrating that when operating in accordance with the defined controls for material attributes and process parameters, the process is able to deliver quality attributes and process performance results in compliance with their pre-defined ranges, should be presented. 3

5 Process evaluation Where appropriate, evaluation of selected step(s) operating in worst case and/or abnormal conditions (e.g. cumulative hold time, spiking challenge) could be performed to support or demonstrate the robustness and the capability of the process to deliver product of the intended quality in these conditions. In some cases, these activities could be built into process verification studies. Depending on the level of evidence provided to demonstrate the high performance of the step(s) and the relevance of experimental model with regards to the final process, these studies could leverage data requirements for process verification (e.g. reduced number of batches) and/or control strategy (e.g. alternative approach to end product testing). Process evaluation: main data to support PAR? 4

6 Process verification Process verification studies should confirm that the final manufacturing process (i.e. full scale commercial process) performs effectively and is able to produce a drug substance or intermediate meeting its predetermined controls and acceptance criteria. Process verification data (e.g. process step results, batch analyses) should be presented in the MAA on an appropriate number of batches (to confirm consistency) produced with the commercial process and scale Process verification studies should normally be completed and included in the Marketing Authorisation Application. In some circumstances, concurrent validation could exceptionally be considered. As an alternative approach, continuous process verification could facilitate registration of concurrent validation studies and/or manufacturing process changes throughout the remainder of the product lifecycle. Process verification: main data to set Normal Operating Ranges? 5

7 Continued process verification Subsequent to successful process validation activities for MAA Monitor product quality and process performance to ensure that a state of control is maintained throughout the commercial part of the product lifecycle. To be performed in compliance with EU GMP Presentation of continued process verification program in MAA to support process validation? Include extended control system performed at appropriate frequency, in accordance to internal limits? acceptance limits? Include protocols covering aspects that will be verified on an ongoing basis? Periodicity? 6

8 Continued vs Continuous Process Verification Aim Frequency Testing/Monitoring Enabler Continous Process Verification - Initial demonstration and/or maintenance of a state of control - uninterrupted - timely manner - Not limited to CPP and CQA - Include process performance - PAT tools (MSPC, in-line control ) - Extensive process knowledge and understanding Continued (/ongoing?) Process Verification - maintenance of a state of control - Lifecycle management - resumed after interruption / periodic - could be built into Continuous PV - GMP compliance - Control strategy during product lifecycle (ex. design space verification) MAA Submission - Included in the MAA - Prospective proposal - May be described in MAA 7

9 Controls included in PV studies Controls (e.g. quality attribute, performance indicator, process parameter, controls implicit in the design of the process): normally go beyond the routine control system performed during routine production. What is the Industry understanding of process performance indicators/parameters for the upstream and downstream processes? Would these terms differ from consistency indicators/parameters? 8

10 Process Parameter [Range tested] Impact on CQA No demonstrated impact on CQA CPP [Target ranges] [Range tested] [Range tested] > [Target ranges] [Range tested] >> [Target ranges] potential CPP Larger range to be tested or consider as potential CPP Non-CPP Impact on Performance indicators No impact on Performance indicators Expected to be included in process validation studies 9

11 Culture steps Evaluation of cell culture steps: From the introduction of the starting material in the manufacturing process (e.g. thaw of the WCB) up and beyond production level, Demonstration of capability of consistently delivering inoculates, harvest(s), and ultimately a drug substance of appropriate quality. Considering the complex matrices during cell culture and harvest steps, the evaluation/validation could, in part, rely on the analysis of drug substance and/or intermediates obtained at a later stage of the process. Include control of: specific cell traits or indices (e.g. morphological characteristics, growth characteristics (PDL), cell number, viability biochemical markers, immunological markers, productivity of the desired product, oxygen or glucose consumption rates, ammonia or lactate production rates), operating conditions (e.g. time, temperatures, agitation rates, working volumes, media feed, induction of production, end of culture). End fermentation / initiation of harvest(s): appropriately defined and evaluated. For multiple harvests: evidence that the quality of the product (e.g. yield, content, post translational modifications such as glycosylation, HCP, DNA) are consistent throughout the harvesting steps, or variability appropriately managed by pooling strategy. 10

12 Culture steps Verification of consistency of the process parameters/product quality attributes covering Includes all culture steps under defined manufacturing conditions Process parameters and Performance indicators in accordance to proven acceptable ranges Complete duration of the fermentation process (including entire process time for continuous fermentation) appropriate number of consecutive runs For multiple harvests: confirmation that it will not have an impact on the quality and consistency of drug substances batches Continued Verification could include: Stability (storage) of cell banks? Stability of frozen intermediate? Controls related to change in raw materials? Control of batches derived from additional fermentation campaign (e.g. long fermentation run leading to several harvests and batches per run)? Control of sub-cultures derived at different stages of seed trains each subculture? 11

13 Culture steps Should genetic stability of the cell line be considered as a performance indicator to be part of the validation of the upstream process? Process parameters and quality attributes to be tested? Should qualification of biological raw materials and other raw materials be addressed in the guideline and documented in the dossier? What performance indicators should be considered for the validation of a continuous perfusion process? How to verify reliability/predictability of small-scale models for the upstream and downstream processes? 12

14 Equipment Information about key equipment (cell culture bottles, bags, fermeters) used, should be provided. This typically includes information on size and material. Disposable single use equipment. assess the suitability of the systems used. full scale equipment has to be used. various batches of disposable systems should be used in order to assess their impact on the product quality. When used for media preparation and/or harvesting: their potential impact on the yield and quality of the active material should be studied In case of single-use equipments or facilities, what are the main differences between process validation studies and studies to qualify these equipments and facilities? 13

15 Multifacility production Additions of alternative sites: frequently occurring. new site is rarely identical to the approved process (e.g. include adaptations and/or optimisations) Local adaptations: Normally accepted provided appropriate comparability data are shown. (e.g. different filters with same porosity) how far can this be stretched? (e.g. different scale, conditions, raw materials, centrifugation vs filtration) Alternate process Cannot be ruled out that may give rise to slightly different purity/impurity profile risk of drift with future changes How to manage and validated differences between sites? 14

16 Purification Evaluation: Capacity of the purification procedures to obtain the desired product and to remove product and process-related impurities (e.g. unwanted variants, host cell derived proteins, nucleic acids, carbohydrates, viruses). Quality of process intermediates (i.e. appropriate purity/impurity profile for the given stage) Requires adequate analytical methods For selected step(s): e.g. steps for which high impurity or viral clearance are claimed operating in worst case and/or abnormal conditions (e.g. cumulated hold times, spiking challenge) performed to document the robustness 15

17 Purification Evaluation: Depending on the level of evidence provided: could leverage some process validation and/or control strategy data requirements. Process conditions (e.g. column loading capacity, column regeneration and sanitisation, flow rate, length) should be appropriately evaluated. Performance parameters/indicators (e.g. yield, chromatographic profiles) Pooling strategy and impact on drug substance consistency Columns life time: Demonstration of appropriate performance and integrity (e.g. clearance, collection of intended variants, leaching). small scale studies: appropriate to estimate and set the maximum number of cycles at the time of MAA, Hold times Reprocessing 16

18 Purification Verification: Quality of process intermediates (i.e. appropriate purity/impurity profile for the given stage) Process parameters and Performance indicators in accordance to proven acceptable ranges Continued Verification could include: Control of performance and integrity of operating units (e.g. purification column)? Running period and periodic control of quality attribute(s) for which RTRT is done? Cumulative studies? Reprocessing? 17

19 Reprocessing Reprocessing: introduced back into the process by repeating a step (e.g. filtration) that is part of the established manufacturing procedure. Limited to occasional process excursions. The reason of the failure should be understood and should not impair the quality of the product. Could be allowed only under appropriately defined conditions. Should be described in the MAA. Validation data expected, demonstrating that the reprocessing step(s) do not impact the quality of the active substance. What are Industry views on the information to be documented in the dossier in relation to reprocessing? Is it always restricted to an exceptional event (e.g. mechanical failure of equipment)? 18

20 Process validation for process development following traditional vs enhanced approach Same objective: To establish scientific evidence that a process is capable of consistently delivering a quality drug substance. Data expected: Process evaluation Process verification or continuous process verification +/- Continued process verification 19

21 Process validation for process development following traditional vs enhanced approach Process Evaluation: higher expectations Systematic approach using enablers (eg multivariate analysis, PAT tools, DOE, appropriate models including statistical model) Demonstrated relationship between input/conditions (e.g. material attributes, process parameters) and output (e.g. CQA, Performance indicator) Robustness demonstrated for selected steps (up to complete process), covering sufficiently large ranges Demonstration of the suitability and predictability of scale down models (e.g. qualitative, quantitative, scale dependence) Demonstration that working within design space delivers a quality drug substance. What additional studies would you consider in an enhanced approach versus a traditional approach? How to evaluate and verify reliability/predictability of small-scale models for the upstream and downstream processes? How to demonstrate validation of adaptive processes (e.g. with feed forward/feed back loops)? 20

22 Process validation for process development following traditional vs enhanced approach Process Verification: Compliance of complete process results to control strategy (including IPT and batch analysis) on appropriate number of batches manufactured at target Alternative: continuous process verification Science and risk based, real time approach Controls of process performance and product quality in a timely manner (e.g. PAT tools) To be established upon accumulation of sufficient PV database? Continued process verification could include: Verification in part performed on an ongoing basis after MA if proper evidence provided? Included in CPV? Design space verification protocol? 21

23 EVALUATION CONTINUED PROCESS VERIFICATION VERIFICATION CONTINUED PROCESS VERIFICATION VERIFICATION EVALUATION Data to be submitted in MAA TRADITIONAL APPROACH ENHANCED APPROACH 22

24 Workshop on process validation Closing remarks Kowid Ho

25 Process validation biotech drug substance General concepts Objective: To establish scientific evidence that a process is capable of consistently delivering a quality drug substance. Will justify the manufacturing process described in S2.2 More consistent data submitted and assessed Data expected: Process evaluation (small and/or full scale) Process verification (full scale) or continous process verification +/- Continued process verification 24

26 Process validation biotech drug substance General concepts Issue with terminology Process Characterisation: to design intended process Evaluation: for the process representative of final process Verification: full scale +/- at target Continued Verification Process PERFORMANCE indicators/parameters vs CONSISTENCY indicators vs KEY PERFORMANCE indicators Differenciation between input and output? Process performance indicators and parameters that don t impact CQA s do not need to be included as regulatory commitments in the MAA? Point that will require further discussion 25

27 Process Parameter [Range tested] Impact on CQA No demonstrated impact on CQA CPP [Target ranges] [Range tested] [Range tested] > [Target ranges] [Range tested] >> [Target ranges] potential CPP Larger range to be tested or consider as potential CPP Non-CPP Impact on Performance indicators No impact on Performance indicators Expected to be included in process validation studies 26

28 Process validation biotech drug substance General concepts Justification of PAR Mainly based from evaluation data? Excursion from PAR: GMP issue? Justification of NOR Mainly based from verification data? 27

29 Continued vs Continuous Process Verification Aim Frequency Testing/Monitoring Enabler Continous Process Verification - Initial demonstration and/or maintenance of a state of control - uninterrupted - timely manner - Not limited to CPP and CQA - Include process performance - PAT tools (MSPC, in-line control ) - Extensive process knowledge and understanding Continued (/ongoing?) Process Verification - maintenance of a state of control - Lifecycle management - resumed after interruption - periodic - GMP compliance - Control strategy during product lifecycle (ex. design space verification) MAA Submission - Included in the MAA - Prospective proposal - May be described in MAA 28

30 Process validation biotech drug substance General concepts Non-CPP measures included: Markers of process consistency Only if non redundant or indicator status? Material and intermediate attributes linked to CQA outcomes Indirect or indicator parameter or attributes demonstrating drift or loss of control Multi-signal/multi-parameter probes Shear forces, gas exchange rates, column-ligand density, noncritical attribute abundance or quality 29

31 Upstream Genetic stability of the cell line Done prior to validation Already captured in Q5s Process parameters and quality attributes to be tested Inputs: can be varied; eg Process parameters Outputs CQA Performance indicators (cell density, viability) Consistency indicator? Indicator : more appropriate for output? Criticality continuum where to draw the line? Controlled within narrow range? For early warning sign? 30

32 Upstream Multi-harvest approach Strategy company dependent Need to cover complete harvest Performance indicators for the validation of a continuous perfusion process Indicators and QA not that different from discontinuous fermentation 31

33 Upstream & Downstream Qualification of biological raw materials and other raw materials Difficult to incorporate different lots in to validations studies Evaluation to be performed to analyze potential variability Risk based approach Critical Raw Material need to be identified? Test frequency Depends on process and product understanding, overall control strategy Less understood : More testing For non release assay: demonstrated fit for purpose 32

34 Upstream & Downstream Single use Risk assessment impact on performance and QA; eg could be handled as high risk raw material for upstream attention on extrables/leachables Quality of the bags (eg sterility of bags) covered by vendor qualification? Same principles for downstream and upstream 33

35 Upstream & Downstream Multifacility List of difference + justification How far can be stretched? Difficult to draw the line Purpose and outputs still the same? Risk assessment on potential impact / comparability exercise PV to be done 34

36 Upstream & Downstream Scale Down Models (SDM) Incomplete representation but needed! Description and justification of inputs, design and outputs Can explore large ranges Outputs: Product quality attributes > Performance indicators > Other characteristics SDM should match large scale at target Statistical approach: difficult to conclude with limited number of full scale batches Non-equivalence & offsets "a question of confidence Depend on the intended use Ideal should include off-target; doable for downstream? Could be done for upstream? Could be leverage by proper control strategy / continued PV 35

37 Downstream Reprocessing Extraordinary Reprocess step does not impact product quality Root cause clearly identified and does not impact product quality Mainly limited to re-filtration or re-concentration steps Adaptive process and feed back loops No real example of product quality directly measured in the process; future? 36

38 Downstream Hold times: Long vs short time storage Often, storage of intermediates is impractical at small scale Cumulative studies of DS bulk: if stored > weeks; impact on DP stability to be assessed If stored > months unreasonable, could take years Intermediate hold Cummulating unlikely; unreasonable? Program to be included in Continued PV? 37

39 Downstream Pooling intermediate Intemediate of specified quality Homogeneity ensured by mixing studies Option to be described in dossier 38

40 Enhanced/QbD approach Additional studies for enhanced approach Mixture; PV approach likely to be a continuum from tradition to enhanced More integrated approach SDM including Non-clinical and clinical aspects Describe and manage influence of CPP on CQA Control of materials (RM, intermediates ) Flexibility Considered as an OUTCOME rather than the AIM of enhanced approach for regulators Also depends on data and knowledge shared 39

41 EVALUATION CONTINUED PROCESS VERIFICATION VERIFICATION CONTINUED PROCESS VERIFICATION VERIFICATION EVALUATION Data to be submitted in MAA TRADITIONAL APPROACH ENHANCED APPROACH 40

42 Closing remark Continuous discussions to be continued Thanks you all!!! 41

43 Workshop on process validation Closing remarks Kowid Ho

44 Process validation biotech drug substance General concepts Objective: To establish scientific evidence that a process is capable of consistently delivering a quality drug substance. Will justify the manufacturing process described in S2.2 More consistent data submitted and assessed Data expected: Process evaluation (small and/or full scale) Process verification (full scale) or continous process verification +/- Continued process verification 1

45 Process validation biotech drug substance General concepts Issue with terminology Process Characterisation: to design intended process Evaluation: for the process representative of final process Verification: full scale +/- at target Continued Verification Process PERFORMANCE indicators/parameters vs CONSISTENCY indicators vs KEY PERFORMANCE indicators Differenciation between input and output? Process performance indicators and parameters that don t impact CQA s do not need to be included as regulatory commitments in the MAA? Point that will require further discussion 2

46 Process Parameter [Range tested] Impact on CQA No demonstrated impact on CQA CPP [Target ranges] [Range tested] [Range tested] > [Target ranges] [Range tested] >> [Target ranges] potential CPP Larger range to be tested or consider as potential CPP Non-CPP Impact on Performance indicators No impact on Performance indicators Expected to be included in process validation studies 3

47 Process validation biotech drug substance General concepts Justification of PAR Mainly based from evaluation data? Excursion from PAR: GMP issue? Justification of NOR Mainly based from verification data? 4

48 Continued vs Continuous Process Verification Aim Frequency Testing/Monitoring Enabler Continous Process Verification - Initial demonstration and/or maintenance of a state of control - uninterrupted - timely manner - Not limited to CPP and CQA - Include process performance - PAT tools (MSPC, in-line control ) - Extensive process knowledge and understanding Continued (/ongoing?) Process Verification - maintenance of a state of control - Lifecycle management - resumed after interruption - periodic - GMP compliance - Control strategy during product lifecycle (ex. design space verification) MAA Submission - Included in the MAA - Prospective proposal - May be described in MAA 5

49 Process validation biotech drug substance General concepts Non-CPP measures included: Markers of process consistency Only if non redundant or indicator status? Material and intermediate attributes linked to CQA outcomes Indirect or indicator parameter or attributes demonstrating drift or loss of control Multi-signal/multi-parameter probes Shear forces, gas exchange rates, column-ligand density, noncritical attribute abundance or quality 6

50 Upstream Genetic stability of the cell line Done prior to validation Already captured in Q5s Process parameters and quality attributes to be tested Inputs: can be varied; eg Process parameters Outputs CQA Performance indicators (cell density, viability) Consistency indicator? Indicator : more appropriate for output? Criticality continuum where to draw the line? Controlled within narrow range? For early warning sign? 7

51 Upstream Multi-harvest approach Strategy company dependent Need to cover complete harvest Performance indicators for the validation of a continuous perfusion process Indicators and QA not that different from discontinuous fermentation 8

52 Upstream & Downstream Qualification of biological raw materials and other raw materials Difficult to incorporate different lots in to validations studies Evaluation to be performed to analyze potential variability Risk based approach Critical Raw Material need to be identified? Test frequency Depends on process and product understanding, overall control strategy Less understood : More testing For non release assay: demonstrated fit for purpose 9

53 Upstream & Downstream Single use Risk assessment impact on performance and QA; eg could be handled as high risk raw material for upstream attention on extrables/leachables Quality of the bags (eg sterility of bags) covered by vendor qualification? Same principles for downstream and upstream 10

54 Upstream & Downstream Multifacility List of difference + justification How far can be stretched? Difficult to draw the line Purpose and outputs still the same? Risk assessment on potential impact / comparability exercise PV to be done 11

55 Upstream & Downstream Scale Down Models (SDM) Incomplete representation but needed! Description and justification of inputs, design and outputs Can explore large ranges Outputs: Product quality attributes > Performance indicators > Other characteristics SDM should match large scale at target Statistical approach: difficult to conclude with limited number of full scale batches Non-equivalence & offsets "a question of confidence Depend on the intended use Ideal should include off-target; doable for downstream? Could be done for upstream? Could be leverage by proper control strategy / continued PV 12

56 Downstream Reprocessing Extraordinary Reprocess step does not impact product quality Root cause clearly identified and does not impact product quality Mainly limited to re-filtration or re-concentration steps Adaptive process and feed back loops No real example of product quality directly measured in the process; future? 13

57 Downstream Hold times: Long vs short time storage Often, storage of intermediates is impractical at small scale Cumulative studies of DS bulk: if stored > weeks; impact on DP stability to be assessed If stored > months unreasonable, could take years Intermediate hold Cummulating unlikely; unreasonable? Program to be included in Continued PV? 14

58 Downstream Pooling intermediate Intemediate of specified quality Homogeneity ensured by mixing studies Option to be described in dossier 15

59 Enhanced/QbD approach Additional studies for enhanced approach Mixture; PV approach likely to be a continuum from tradition to enhanced More integrated approach SDM including Non-clinical and clinical aspects Describe and manage influence of CPP on CQA Control of materials (RM, intermediates ) Flexibility Considered as an OUTCOME rather than the AIM of enhanced approach for regulators Also depends on data and knowledge shared 16

60 EVALUATION CONTINUED PROCESS VERIFICATION VERIFICATION CONTINUED PROCESS VERIFICATION VERIFICATION EVALUATION Data to be submitted in MAA TRADITIONAL APPROACH ENHANCED APPROACH 17

61 Closing remark Continuous discussions to be continued Thanks you all!!! 18

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