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![Optimize your process validation package
13
What is Process Validation?
A regulatory requirement
FDA guideline [1]
Process Validation is “the collection and evaluation of data, from the
process design stage through commercial production, which establishes
scientific evidence that a process is capable of CONSISTENTLY delivering
quality product”.
EMA guideline [2, 3]
“Process validation is the documented evidence that the process, operated
within established parameters, can perform EFFECTIVELY and REPRODUCIBLY
to produce an active substance or intermediate, meeting its predetermined
specifications and quality attributes”.
[1] « Guidance for Industry : Process validation : general principles and practices », FDA, 2015
[2] « Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission », EMA, 2016
[3] « ICH Q7A Godd manufacturing practice guide for active pharmaceutical ingredients », ICH, 2010](https://image.slidesharecdn.com/processvalidationwebinar-slideshare-210624141427/85/Optimize-Your-Process-Validation-Package-13-320.jpg)
Uploaded byMerck Life Sciences
Optimize Your Process Validation Package
The document discusses process validation in the life science business of Merck KGaA, operating as MilliporeSigma in the U.S. and Canada, emphasizing its critical role in ensuring consistent quality in biotechnological product manufacturing. It highlights key considerations, critical success factors, the lifecycle approach to validation, and the importance of adapting strategies based on product and regulatory requirements. The presentation outlines the steps involved in successful registration and commercial manufacturing, including a risk-based approach to validation and emphasizing the use of single-use technologies.
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Optimize Your Process Validation Package
- 1. The life sciencebusiness of Merck KGaA, Darmstadt, Germany operates as MilliporeSigma in the U.S. and Canada. Christian Cattaruzza Corinne Lavie-Cambot David Delvaille BioReliance® End-to-End Solutions Optimize your Process validation Package!
- 2. The life sciencebusiness of Merck KGaA, Darmstadt, Germany operates as MilliporeSigma in the U.S. and Canada
- 3. Agenda Process validation keyconsiderations and critical success factors, Christian Cattaruzza Process validation for biotechnological products, Corinne Lavie- Cambot Case study: efficient discrimination of critical process, David Delvaille 1 2 3
- 4. Process validation Key considerations andcritical success factors
- 5. process validation IS… Aseries of activities taking place over the lifecycle of the product and process process Validation IS NOT… A one-time event or an activity performed just prior to commercial launch Objective: • Demonstrate that the manufacturing process is capable of consistently producing acceptable quality products within the commercial manufacturing conditions • Build confidence to regulatory authorities that a process is consistently under control and can remain in control Critical steps towards successful registration and commercial manufacturing Process Validation Definition and Purpose Optimize your process validation package 5
- 6. 6 - The processmust be frozen prior to starting process validation activities • Limited information and data available from clinical stage - Process knowledge should be developed and documented along clinical development - Single-use technologies simplify and speed up process validation and technical transfer • Standardization of process equipment • Simplified process validation (Cleaning validation) • Simplified technical transfers - Regulatory agencies expectations will depend on the nature of the project and the biologic drug • Process validation strategy to be adapted Critical steps towards successful registration and commercial manufacturing Process Validation Scope and Activities Optimize your process validation package
- 7. Documented risk-based approach- Estimate residual risk for the patient considering: Product knowledge (existing accumulated experience) Process knowledge and understanding (existing accumulated experience) Appropriateness of the Control Strategy What is the appropriate quantity and type of data to demonstrate that the process delivers reproducibly a product that meets pre-determined quality attributes? What is the expected time to market? Is there any regulatory designation such as a breakthrough therapy or fast track approval? Process Validation Scope and Activities Process Validation Strategy Speed to Market Risk Take time to characterize process and gain knowledge Slow Low Take shortcuts to save time at cost of building process knowledge and data Fast High Risk-based approach based on experience of molecule, processes and equipment Fast Medium How to determine validation needs? Optimize your process validation package 7
- 8. Phase I Pre-clinical PhaseII Phase III Commercial Cell line development (any mammalian cells) Cell banking USP/ DSP process development Templated or customized Analytical development GMP clinical manufacturing Single-use 50 to 2.000L scale Product characterization testing PPQ campaign, GMP commercial manufacturing Single-use 200 to 2.000L scale Process optimization/ scale up/ fitting Process characterization Process & analytical validation We are your full-service biologics CDMO with late-stage capabilities that get you ready for to commercial success 8
- 9. Optimize your processvalidation package 9 Global resources Locally delivered Biodevelopment and production Product characterization, Biosafety testing Cell line development Boston, US Shanghai, China GMP Bordeaux, France GMP Wisconsin St Louis Glasgow, UK Rockville Singapore Validation Services Molsheim, France Bangalore, India Yokohama, Japan
- 10. 1987 Converted into a fullySingle-Use GMP facility in Martillac, France 1995 Production of the first GMP batch 2015 Creation of the first CDMO site in Martillac, France 2011 Scaled up to 2,000 L bioreactor 2017 • Opening of non- GMP facilities in Shanghai, China & Burlington, USA 2018 Opening of GMP facility in Shanghai, Pudong, China 2020 China facility delivers first full- scope project • Opening of GMP commercial facility in Martillac, France • Expansion of our development center in Burlington, MA 2022 • Built within one year A History of 34+ Years of Global Contract Development and Manufacturing Success Optimize your process validation package 10
- 11. Our BioReliance® End-to-End facilitiesare GMP certified 1 5 8 33 57 76 91 98 99 103 107 109 116 122 129 129 131 133 136 139 141 142 145 148 150 154 163 176 191 204 219 234 251 267 272 1st production in batch without FBS 1st batch in 250L 1st perfusion process 1st clinical batch produced in proteins free media 1st cell bank without FBS Last process developed with FBS 2 x 1250L capacity increase Single Use 100% successful scale up Revamping with full single Use process 1st PPQ run campaign for an FDA Fast Track designation GMP certified Major milestones: 1987-2021 molecules 2011-2021 >100 molecules developed to GMP manufacturing Optimize your process validation package 11 We abide to our global Group Quality Systems
- 12.
- 13. Optimize your processvalidation package 13 What is Process Validation? A regulatory requirement FDA guideline [1] Process Validation is “the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of CONSISTENTLY delivering quality product”. EMA guideline [2, 3] “Process validation is the documented evidence that the process, operated within established parameters, can perform EFFECTIVELY and REPRODUCIBLY to produce an active substance or intermediate, meeting its predetermined specifications and quality attributes”. [1] « Guidance for Industry : Process validation : general principles and practices », FDA, 2015 [2] « Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission », EMA, 2016 [3] « ICH Q7A Godd manufacturing practice guide for active pharmaceutical ingredients », ICH, 2010
- 14. Optimize your processvalidation package 14 What is Process Validation consisting in? Three stages – A Lifecycle Drug Substance/Product approach Regulatory Submission Process Design Process Development and Evaluation Process Qualification Facility & Equipment Qualification Process Performance Qualification (PPQ) & validation studies Process Verification Continued Process Verification (CPV) Ongoing Process Verification (OPV) U.S. Food & Drug Administration (FDA) European Medicines Agency (EMA) Stage 1 Stage 2 Stage 3
- 15. Optimize your processvalidation package 15 What are the critical paths to go to BLA submission? VMP cQA pCPP/CMA Process Characterization pCPP/PAR pPCS PPQ campaign Viral clearance PPQ reports Final PCS CPV protocol Qualified Scale Down Model Locked commercial process Validated analytical methods BLA SUBMISSION STAGE 1 STAGE 2 PROCESS VALIDATION STUDIES Others Asmt
- 16. Optimize your processvalidation package 16 What are the validation studies to perform? MIXING/HOMOGENEITY STUDIES Shipment studies Studies from assessments Resin / Membranes Studies Freeze- Thaw Studies Stability / Holding times Studies Mixing / Homogeneity Studies Viral Clearance Studies Shipment studies DS QC Sample Freeze - Thaw studies DS QC Sample Resin / Membranes studies Recycling Cleaning Viral Clearance studies New resins Aged resins Stability / Holding time studies Media/Buffer Solutions Process Intermediates Drug Substance QC samples Resins/membranes Mixing / Homogeneity studies Media/Buffer Solutions Process Intermediates Drug Substance
- 17. Optimize your processvalidation package 17 When is it convenient to validate a process? Discovery Development Preclinial research Phase I Phase II Phase III Phase IV Commercial Clinical Phases Stage 1 Stage 2 Stage 3 Regulatory Submission Process Validation Exercice In Theory Commercial Strategy Product Designation Evaluation based on risk assessment
- 18. To see therest of the presentation and get real- life examples from our speakers, participate in the full, interactive on-demand webinar. Watch Now
- 19. The vibrant M,BioReliance and CHOZN are trademarks of Merck KGaA, Darmstadt, Germany or its affiliates. All other trademarks are the property of their respective owners. Detailed information on trademarks is available via publicly accessible resources. © 2021 Merck KGaA, Darmstadt, Germany and/or its affiliates. All Rights Reserved.