Watch the presentation of this webinar here: https://bit.ly/3wT5Irt
The Emprove® Program is constantly expanding and updating. Find out about the recently launched Emprove® CCM category for our cell culture media portfolio, the new Emprove® API Information Packages, and the latest updates on available TUPPs for our Emprove® Chemicals portfolio.
This virtual user group will introduce the two latest additions to the Emprove® Program:
1. Our latest category Emprove® CCM for our cell culture media with wave 1 focus on our Cellvento® CHO cell culture media portfolio, looking also into the content of our three Emprove® Dossiers.
2. The new Emprove® API Information Packages that are currently created for our Emprove® APIs, looking into the content and showing how to access.
Additionally, we'll give an overview of latest Technically Unavoidable Particle Profiles (TUPPs) for our Emprove® Chemicals.
In this virtual user group, you will learn:
• Emprove® CCM and its documentation for our cell culture media
• Content and availability of the new Emprove® API Information Package
• Update on available TUPPs for our Emprove® Chemicals
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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
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
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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
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
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Out of scope
Standard / classical media (eg. DMEM, GMEM)
10. Dossier Structure
Emprove® CCM
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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
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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
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Specification
Originial Manufacturer
ISO 9001 Certificate
13. Material Qualification Dossier
Emprove® CCM
Emprove® Virtual User Group Meeting | June 1st 2021
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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
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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
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
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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
19. Dossier Structure
Emprove® CCM
Emprove® Virtual User Group Meeting | June 1st 2021
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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
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
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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
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
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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
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* http://eudragmdp.ema.europa.eu/inspections/gmpc/searchGMPCompliance.do;jsessionid=FdxKinNcvHto_mTjMJAtz3O1xm1iK0yrk07LmD-rcl4bCSJrozh6!814916889
28. Other relevant product certificates Package
Emprove® API Information Package
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TSE/BSE
Allergen
Mycotoxin/Aflatoxin
GMO
Nitrosamine
Melamine
Kosher
Halal
29. Stability Summary and Conclusion
Emprove® API Information Package
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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
34. Detailed information for each type of TUP
From Reactive to Proactive
Emprove® Virtual User Group Meeting | June 1st 2021
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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
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38. New
Technically Unavoidable Particle Profiles (TUPPs)
Emprove® Virtual User Group Meeting | June 1st 2021
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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