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Seminar 4.1
The Module 3 (CMC Dossier) of biopharmaceuticals
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The Module 3 of the CTD of biopharmaceuticals
CMC data requirements of biopharmaceuticals
Module 3 dossier and data requirements for biopharmaceuticals in the USA and Japan
Relevant EMA and ICH CMC-related guidelines
Special areas to be considered for biopharmaceuticals
o Formulation and stability
o Critical process and quality attributes
o Isoform characterization and glycosylation of biopharmaceuticals
o Potency determination
o Comparability
o Virus and TSE safety
CMC data requirement for biosimilars
CMC particulars of ADC
Typical pitfalls in regulatory submissions
20 – 23 January 2015
Freiburg, Hotel Novotel am Konzerthaus, Room Colmar
Course Leaders:
Beatrix Metzner
Boehringer Ingelheim Pharma GmbH & Co. KG
Mairéad Duke
Épée Services Ltd.
Programme
Day 1, Tuesday, 20 January 2015
09.15 – 09.30
Welcome and introduction
Beatrix Metzner and Mairéad Duke
09.30 – 10.30
The structure of the Quality Module 3 of the CTD for biopharmaceuticals and
the relevant guidelines
This session provides an introduction into the Module 3 structure first
which is used throughout the seminar as a kind of frame, in which the
individual headings of the structure are embedded either as interactive
sessions or as presentations.
Mairéad Duke
10.30 – 11.00 Coffee break
11.00 – 11.30
First interactive session of the dossier and data requirements for the individual
sections of the Module 3.
For all interactive sessions, Beatrix Metzner and Mairéad Duke develop with
the audience the content related to biopharmaceuticals and will summarise at
the end of the session the essentials.
EUCRAF. Seminar 4.1:
www.eucraf.eu
20 - 23 January 2015
Programme
Phone: +49 (0)761 13734424
Page 1 of 5
E-mail: info@eucraf.eu
To start with:
General information (3.2.S.1 and 3.2.P.1)
11.30 – 12.15
Manufacture (3.2.S.2. and 3.2.P.3) (Interactive session)
12.15 – 13.00
Control of Materials (3.2.S.2.3.) (Interactive session)
13.00 – 14.00 Lunch
14.00 – 16.00
How do ICH Q 8, 9 and 10 determine the Module 3 structure and content:
Controls of critical steps and intermediates (3.2.S.2.4 and 3.2.P.3.4.)
Process validation (3.2.S.2.5. and 3.2.P.3.5.)
Manufacturing process development (3.2.S.2.6. and 3.2.P.2.)
Beatrix Metzner
16.00 – 16.30 Coffee break
16.30 – 17.30
Continued
17.30 End of Day 1
19.00 Get-together with food and wine
EUCRAF. Seminar 4.1:
www.eucraf.eu
20 - 23 January 2015
Programme
Phone: +49 (0)761 13734424
Page 2 of 5
E-mail: info@eucraf.eu
Day 2, Wednesday, 21 January 2015
09.15 – 11.15
Characterisation of biopharmaceuticals (3.2.S.3)
 Parameters investigated
 Heterogeneity and isoforms
 Glycosylation
 Undesired modifications of molecules
 Potency determination
 Impurities
Heike Volkmer, Volkmer & Burt Consulting Team
11.15 – 11.45 Coffee break
11.45 – 13.00
Control of Drug Substance / Drug Product (3.2.S.4. and 3.2.P.5.) (Interactive
session)
13.00 – 14.00 Lunch
14.00 – 15.00
Continued
15.00 – 16.00
Virus and TSE-safety of biopharmaceuticals
 Selection of starting material
 Starting material and auxiliary material of animal and/or human origin
used in the process or formulation of the medicinal product
Virus validation of the manufacturing process capacity to inactivate and
remove viruses and TSE
Hannelore Willkommen, Regulatory Affairs & Biological Safety Consulting
16.00 – 16.30 Coffee break
16.30 – 18.15
Continued
18.15 End of Day 2
EUCRAF. Seminar 4.1:
www.eucraf.eu
20 - 23 January 2015
Programme
Phone: +49 (0)761 13734424
Page 3 of 5
E-mail: info@eucraf.eu
Day 3, Thursday, 22 January 2015
09.15 – 10.45
Interactive session
Reference Standards (3.2.S.5. and 3.2.P.6.)
Container Closure System 3.2.S.6. and 3.2.P.7.)
Stability (3.2.S.7. and 3.2.P.8.)
10.45 – 11.15 Coffee break
11.15 – 13.00
Interactive session
The comparability exercise – what to do and what to present in the dossier
when the manufacturing process is changed
13.00 – 14.00 Lunch
14.00 – 16.00
Formulation and drug product manufacturing of biopharmaceuticals
• Formulation development
• Process development
• Routes of administration
• Special developments to modify proteins and formulations
Michael Ausborn, F. Hoffmann-La Roche Ltd.
16.00 – 16.30 Coffee break
16.30 – 18.30
Considerations for the CMC development and submission requirements for a
drug-device combination product
Florian Lengyel, Boehringer Ingelheim Pharma GmbH & Co. KG
18.30 End of Day 3
For Full Course Students (Gabriele Dallmann):
18.30 – 18.45
EUCRAF. Seminar 4.1:
www.eucraf.eu
Introduction to the homework
20 - 23 January 2015
Programme
Phone: +49 (0)761 13734424
Page 4 of 5
E-mail: info@eucraf.eu
Day 4, Friday, 23 January 2015
09.15 – 11.00
CMC particulars of biosimilars
Beatrix Metzner
11.00 – 11.30 Coffee break
11.30 – 12.45
CMC particulars of ADC (Antibody Drug Conjugates)
Mairéad Duke
12.45 – 13.45 Lunch
13.45 – 14.30
What is special in other regions on Module 3 requirements?
 USA
 Japan
 Other regions
14.30 – 16.30
Beatrix Metzner
Regulatory CMC concerns and issues
Jörg Engelbergs, Paul-Ehrlich-Institut
16.30 End of Seminar 4.1
EUCRAF. Seminar 4.1:
www.eucraf.eu
20 - 23 January 2015
Programme
Phone: +49 (0)761 13734424
Page 5 of 5
E-mail: info@eucraf.eu