The Emprove® Program: Introduction of New Portfolio Additions
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The document discusses the Emprove® program from Merck KGaA, highlighting its aim to provide comprehensive information and support for materials used in life sciences, including various dossiers for material qualification and operational excellence. It outlines the structure and content of these dossiers, which cover specifications, quality management, and risk assessment, alongside an overview of product offerings in cell culture media and active pharmaceutical ingredients (APIs). The virtual meeting on June 1, 2021, focused on updates, user feedback, and the integration of new content within the Emprove® suite.
The Emprove® Program: Introduction of New Portfolio Additions
- 1. The life science business of Merck KGaA, Darmstadt, Germany operates as MilliporeSigma in the U.S. and Canada. Emprove® Virtual User Group Meeting Torsten Schadendorf June 1st 2021
- 2. The life science business of Merck KGaA, Darmstadt, Germany operates as MilliporeSigma in the U.S. and Canada
- 3. Agenda 1 2 3 The Emprove® Program - an Overview Emprove® CCM Emprove® API Information Package 4 Technically Unavoidable Particle Profiles (TUPPs) - An Update
- 4. The Emprove® Program – an Overview
- 5. ... Convenient Access ... ... for a Broad Portfolio. ... to reliable information ... The Emprove® Program at a glance… Emprove® Virtual User Group Meeting | June 1st 2021 5
- 6. Chemicals Expanding content PharmaGradeTM Integration in progress Filters & Single use Constant portfolio expansion, supporting launches Chromatography Launched Q2/2020 Cell Culture Media Launched Q4/2020 Emprove® Material Qualification Dossier Emprove® Quality Management Dossier Emprove® Operational Excellence Dossier Portfolio, Dossiers, Suite Emprove® Program Emprove® Suite Emprove® Virtual User Group Meeting | June 1st 2021 6
- 7. POLL QUESTION 1 Title of Presentation | DD.MM.YYYY 7 Do the information in the Emprove® Dossiers and/or the Emprove® Suite help you to assess the risk associated with (please check all that apply)? o Raw Material Sourcing o Raw Material Qualification o Raw Material Performance o All of the Above
- 8. Emprove® CCM
- 9. Product Scope Emprove® CCM In scope Chemically-defined media Selected media for Gene Editing and Novel Modalities Custom Media Product Family Cellvento® media (wave 1) EX-CELL® Advanced Media (wave 2) EX-CELL® Insect Media (wave 2) EX-CELL® Lenti Media (wave 2) Custom Media (wave 3) Emprove® Virtual User Group Meeting | June 1st 2021 9 Out of scope Standard / classical media (eg. DMEM, GMEM)
- 10. Dossier Structure Emprove® CCM Emprove® Virtual User Group Meeting | June 1st 2021 10 Operational Excellence Dossier Trace Element Information Origin of Raw Materials Analytical procedures Supports process optimization Material Qualification Dossier General information Specification Manufacture Address, Manufacturing Flowchart, ISO Cert, GMP Statement Homogeneity Statement Characterization Statements TSE/BSE, Virus Safety, GMO, Components of Interest Control of CCM CoAs, Label, Batch Numbering Container closure system Stability Information to start a material qualification Quality Management Dossier Supply Chain Information Product Quality Self Assessment Site Quality Self Assessment Supplier Management Stability data Answers questions during risk assessment
- 11. Dossier Structure Emprove® CCM Emprove® Virtual User Group Meeting | June 1st 2021 11 Operational Excellence Dossier Trace Element Information Origin of Raw Materials Analytical procedures Supports process optimization Material Qualification Dossier General information Specification Manufacture Address, Manufacturing Flowchart, ISO Cert, GMP Statement Homogeneity Statement Characterization Statements TSE/BSE, Virus Safety, GMO, Components of Interest Control of CCM CoAs, Label, Batch Numbering Container closure system Stability Information to start a material qualification Quality Management Dossier Supply Chain Information Product Quality Self Assessment Site Quality Self Assessment Supplier Management Stability data Answers questions during risk assessment
- 12. Material Qualification Dossier Emprove® CCM Emprove® Virtual User Group Meeting | June 1st 2021 12 Specification Originial Manufacturer ISO 9001 Certificate
- 13. Material Qualification Dossier Emprove® CCM Emprove® Virtual User Group Meeting | June 1st 2021 13 Specification Originial Manufacturer ISO 9001 Certificate Manufacturing Process Validation Report - Open Part Packaging Material CoA (examples) Product label / batch numbering system (example)
- 14. Material Qualification Dossier Emprove® CCM Emprove® Virtual User Group Meeting | June 1st 2021 14 Specification Originial Manufacturer ISO 9001 Certificate Manufacturing Process Validation Report - Open Part Packaging Material CoA (examples) Product label / batch numbering system (example) Certificates TSE/BSE Viral Safety GMO Homogeneity Components of Interest
- 15. Emprove® CCM Material Qualification Dossier Emprove® Virtual User Group Meeting | June 1st 2021 15
- 16. Quality Management Emprove® CCM Emprove® Virtual User Group Meeting | June 1st 2021 16 IPEC-PQG GMP Guide applied to Cellvento® media platform with scope of Emprove® Program
- 17. Dossier Structure Emprove® CCM Emprove® Virtual User Group Meeting | June 1st 2021 17 Operational Excellence Dossier Trace Element Information Origin of Raw Materials Analytical procedures Supports process optimization Material Qualification Dossier General information Specification Manufacture Address, Manufacturing Flowchart, ISO Cert, GMP Statement Homogeneity Statement Characterization Statements TSE/BSE, Virus Safety, GMO, Components of Interest Control of CCM CoAs, Label, Batch Numbering Container closure system Stability Information to start a material qualification Quality Management Dossier Supply Chain Information Product Quality Self Assessment Site Quality Self Assessment Supplier Management Stability data Answers questions during risk assessment
- 18. Quality Management Dossier Emprove® CCM Emprove® Virtual User Group Meeting | June 1st 2021 18
- 19. Dossier Structure Emprove® CCM Emprove® Virtual User Group Meeting | June 1st 2021 19 Operational Excellence Dossier Trace Element Information Origin of Raw Materials Analytical procedures Supports process optimization Material Qualification Dossier General information Specification Manufacture Address, Manufacturing Flowchart, ISO Cert, GMP Statement Homogeneity Statement Characterization Statements TSE/BSE, Virus Safety, GMO, Components of Interest Control of CCM CoAs, Label, Batch Numbering Container closure system Stability Information to start a material qualification Quality Management Dossier Supply Chain Information Product Quality Self Assessment Site Quality Self Assessment Supplier Management Stability data Answers questions during risk assessment
- 20. Operational Excellence Dossier Emprove® CCM Emprove® Virtual User Group Meeting | June 1st 2021 20
- 21. POLL QUESTION 2 Title of Presentation | DD.MM.YYYY 21 Please rank the following cell culture media information given in the Emprove® dossiers regarding the value for you (1 = highest value) o CCM stability data o Levels of trace elements o Origin of media components/ingredients Is ranking within poll questions possible? If not, please use this question: “Which of the following information shown before are of most value to you?”
- 22. Emprove® CCM Dossier Availability (wave 1: Cellvento® media platform) Emprove® Virtual User Group Meeting | June 1st 2021 22 Article Code Product Emprove® Material Qualification Dossier Emprove® Quality Management Dossier Emprove® Operational Excellence Dossier 103840 Cellvento® 4CHO-X COMP Expansion √ √ √ 103796 Cellvento® 4Feed COMP New New New 103795 Cellvento® 4CHO New New New 101885 Cellvento® CHO-200 New New New 101883 Cellvento® Feed-200 New New New 102577 Cellvento® CHO-220 New New New 102578 Cellvento® Feed-220 New New New 102485 Cellvento® CHO-210 New New New 102488 Cellvento® Feed-210 New New New
- 23. Versioning Emprove® CCM Emprove® Virtual User Group Meeting | June 1st 2021 23
- 25. Emprove® Virtual User Group Meeting | June 1st 2021 25 Emprove® Essential GMP (IPEC) Moderate risk applications Emprove® Expert GMP (IPEC) Higher risk applications Emprove® API GMP (ICH Q7) Chemicals Categories Emprove® Evolve Non-GMP, manufactured utilizing GMP concepts and elements Evolving regulatory needs Emprove® Program for Chemicals
- 26. Content Emprove® API Information Package Emprove® Virtual User Group Meeting | June 1st 2021 26 General Information Manufacture Manufacturer Certificate of GMP Compliance Description of Manufacturing Process Specification Other relevant product certificates Product Quality Self Assessment Packaging Information Stability Summary and Conclusion Purpose: Supporting material qualification, not for registration purposes
- 27. Certificate of GMP Compliance (latest version available on EudraGMDP webpage*) Emprove® API Information Package Emprove® Virtual User Group Meeting | June 1st 2021 27 * http://eudragmdp.ema.europa.eu/inspections/gmpc/searchGMPCompliance.do;jsessionid=FdxKinNcvHto_mTjMJAtz3O1xm1iK0yrk07LmD-rcl4bCSJrozh6!814916889
- 28. Other relevant product certificates Package Emprove® API Information Package Emprove® Virtual User Group Meeting | June 1st 2021 28 TSE/BSE Allergen Mycotoxin/Aflatoxin GMO Nitrosamine Melamine Kosher Halal
- 29. Stability Summary and Conclusion Emprove® API Information Package Emprove® Virtual User Group Meeting | June 1st 2021 29
- 30. POLL QUESTION 3 Title of Presentation | DD.MM.YYYY 30 Do you use APIs only for the intended use as API or (potentially) also in other / adjacent applications (e.g. as excipients in critical formulations)? o Only as API o APIs and further/other applications
- 31. Versioning Emprove® API Information Package Emprove® Virtual User Group Meeting | June 1st 2021 31
- 32. Article Product Name Dossier Availability 108432 Urea cryst. EMPROVE® API Ph Eur, BP, USP √ 100164 Boric acid cryst., EMPROVE® API Ph Eur, BP, NF √ 105040 Potassium iodide EMPROVE® API Ph Eur, BP, JP, USP √ 109828 di-Potassium hydrogen phosphate anhydrous, low in sodium EMPROVE® API Ph Eur, BP, USP √ 106235 Sodium acetate trihydrate EMPROVE® API Ph Eur, BP, JP, USP, FCC, E262 New 106666 tri-Sodium citrate dihydrate low in endotoxins, EMPROVE® API Ph Eur, BP, JP, USP New 102465 Calcium chloride dihydrate EMPROVE® API Ph Eur, BP, JP, USP New 102367 Magnesium chloride hexahydrate cryst. EMPROVE® API Ph Eur, BP, JPC, USP New 500111 Cocarboxylase tetrahydrate EMPROVE® API HY2 / 2021 500112 Cocarboxylase chloride thiamine diphosphoric acid ester chloride EMPROVE® API HY2 / 2021 500667 Thiamine phosphoric acid ester chloride dihydrate EMPROVE® API HY2 / 2021 106441 Sodium fluoride EMPROVE® API Ph Eur, BP, USP HY2 / 2021 106444 Sodium chloride EMPROVE® API Ph Eur, BP, JP, USP HY2 / 2021 108815 Zinc chloride EMPROVE® API Ph Eur, BP, USP HY2 / 2021 106143 Meglumine low in endotoxins EMPROVE® API Ph Eur, ChP, JP, USP HY2 / 2021 128204 Sodium acetate trihydrate EMPROVE® API Ph Eur, BP, JP, USP, FCC, E262 HY2 / 2021 Expected Availability Emprove® API Information Packages 32 Emprove® Virtual User Group Meeting | June 1st 2021
- 33. Technically Unavoidable Particle Profiles (TUPPs) - An Update
- 34. Detailed information for each type of TUP From Reactive to Proactive Emprove® Virtual User Group Meeting | June 1st 2021 34 Intention, quality policy towards foreign particles Flow chart of manufacturing process (reference to MQD) TUP information Particle picture Identity and composition Mass balance Root cause Assessment of additional microbial and BSE risks
- 35. Detailed information for each type of TUP Picture and Identity 35 Emprove® Virtual User Group Meeting | June 1st 2021
- 36. Detailed information for each type of TUP Picture and Identity Emprove® Virtual User Group Meeting | June 1st 2021 36
- 37. Availability Technically Unavoidable Particle Profile (TUPP) Emprove® Virtual User Group Meeting | June 1st 2021 37 Article Product 100419 Parteck® M 200 (Mannitol) EMPROVE® ESSENTIAL Ph Eur,BP,JP,USP,E 421 100494 Parteck® M 100 (Mannitol) EMPROVE® ESSENTIAL Ph Eur,BP,JP,USP,E 421 100892 Sucrose low in endotoxins suitable for use as excipient EMPROVE® exp Ph Eur,BP,JP,NF 107653 Sucrose EMPROVE® ESSENTIAL Ph Eur,BP,JP,NF 101816 Ammonium sulfate EMPROVE® EXPERT ACS,NF 112120 Calcium carbonate precipitated (<= 0.0001% Al) EMPROVE® ESSENTIAL Ph Eur,BP,USP,JP,FCC,E 170 102064 Calcium carbonate precipitated (<= 0.002% Fe) EMPROVE® ESSENTIAL Ph Eur,BP,USP,JP,FCC 106400 Sodium chloride EMPROVE® ESSENTIAL Ph Eur,BP,USP 116224 Sodium chloride low in endotoxins suitable for use as excipient EMPROVE® exp Ph Eur,BP,JP,USP 137017 Sodium chloride EMPROVE® EXPERT Ph Eur,BP,ChP,JP,USP 106482 Sodium hydroxide pellets EMPROVE® ESSENTIAL Ph Eur,BP,FCC,JP,NF,E 524 137020 Sodium hydroxide pellets suitable for the biopharmaceutical production EMPROVE® bio Ph Eur,BP,JP,NF 108346 D(+)-Glucose monohydrate EMPROVE® EXPERT Ph Eur,BP,USP 141350 Polyvinyl alcohol 4-88 EMPROVE® ESSENTIAL Ph Eur,USP,JPE 141351 Polyvinyl alcohol 8-88 EMPROVE® ESSENTIAL Ph Eur,USP,JPE 141352 Polyvinyl alcohol 26-88 EMPROVE® ESSENTIAL Ph Eur,USP,JPE 141353 Polyvinyl alcohol 40-88 EMPROVE® ESSENTIAL Ph Eur,ChP,USP,JPE 141354 Polyvinyl alcohol 5-88 EMPROVE® ESSENTIAL Ph Eur,USP,JPE 141355 Polyvinyl alcohol 18-88 EMPROVE® ESSENTIAL Ph Eur,ChP,USP,JPE 103583 Parteck® SI 150 (Sorbitol) EMPROVE® ESSENTIAL Ph Eur,BP,JP,NF,JSFA,E 420 115079 Parteck® SI 200 (Sorbitol) EMPROVE® ESSENTIAL Ph Eur,BP,JP,NF,E 420 112635 Parteck® Delta M (Mannitol) EMPROVE® ESSENTIAL Ph Eur,BP,USP,JP,E 421 100493 Parteck® M 300 (Mannitol) EMPROVE® ESSENTIAL Ph Eur,BP,JP,USP,E 421 137112 Poloxamer 188 EMPROVE® EXPERT
- 38. New Technically Unavoidable Particle Profiles (TUPPs) Emprove® Virtual User Group Meeting | June 1st 2021 38 Article Product TUPP part of Emprove® OED 105911 Maltose monohydrate EMPROVE® ESSENTIAL Mar 2021 104871 Potassium dihydrogen phosphate cryst., EMPROVE® ESSENTIAL Ph Eur,BP,JPC,NF,E 340 May 2021 137039 Potassium dihydrogen phosphate cryst. EMPROVE® EXPERT Ph Eur,BP,JPC,NF May 2021 105101 di-Potassium hydrogen phosphate anhydrous, EMPROVE® ESSENTIAL Ph Eur,BP,E 340 May 2021 137010 di-Potassium hydrogen phosphate anhydrous EMPROVE® EXPERT Ph Eur,BP,USP May 2021 106349 Sodium dihydrogen phosphate monohydrate EMPROVE® ESSENTIAL BP,USP May 2021 137093 Sodium dihydrogen phosphate monohydrate EMPROVE® EXPERT BP,USP May 2021 106574 di-Sodium hydrogen phosphate heptahydrate EMPROVE® ESSENTIAL DAC,USP May 2021 137092 di-Sodium hydrogen phosphate heptahydrate EMPROVE® EXPERT DAC,USP May 2021 106398 Sodium carbonate anhydrous EMPROVE® ESSENTIAL Ph Eur,BP,JP,NF June / July 137012 Sodium acetate trihydrate EMPROVE® EXPERT Ph Eur,BP,JP,USP June / July 105032 Potassium hydroxide pellets EMPROVE® ESSENTIAL Ph Eur,BP,JP,NF,FCC,E 525 TUPP to be created
- 39. Emprove® Suite Notification System Last but not least Receive a monthly digest of the updates that were made in the previous month to: Emprove® Operational Excellence Dossiers Emprove® Quality Management Dossiers 1 Click on “Be notified of changes to subscription documents” 2 Submit your name and confirm the notification 3
- 40. The vibrant M, SAFC, Millipore, Cellvento, and Emprove 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.