Webcast Biologics
Development, Quality & Regulatory Affairs
QbD elements in early and late stage biotherapeutic development
(from research to first in human until commercial)
Live webcast on 27 November 2018, 14.00 (CET)
Implementation of QbD elements:- Quality attributes / critical quality attributes
- Quality target product profile (QTPP)
- Comparability studies
Dr Dorothee Ambrosius
Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach
Head of CMC Strategy Biologicals
Quality of Biotech-IMPs – the current challenges
Live webcast on 11 December 2018, 14.00 (CET)
- Impact of the current voluntary harmonisation procedure (VHP) and the new clinical trial regulation on pharmaceutical quality
- Current and future regulatory -scientific requirements and challenges with regards to quality and its documentation
Dr Jörg Engelbergs
Paul-Ehrlich-Institut (PEI), Langen
Scientific Expert (CMC/Non-Clinic) for Monoclonal Antibody Therapeutics
Analytical development concepts to guide CMC development
Live webcast on 22 January 2019, 14.00 (CET)
- Current analytical methods
- Specification and validation
- Developmental vs. CMC data
- requested -
Dr René Thürmer
Expert for pharmaceutical Quality, Bonn
Cell line development
Live webcast on 13 February 2019, 14.00 (CET)
- Host cells
- State-of-the-art cell line generation process
- Importance of monoclonality assurance
- Bioreactor assessment
- Phenotypic & genotypic stability
Dr Simon Fischer / Dr Barbara Enenkel
Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach
Head of Cell Line Development CMB / Senior Associate Director Bioprocess and Analytical Development
Virus safety
Live webcast 13 March 2019, 14.00 (CET)
- Potential sources of virus contamination
- Cell line qualification: testing for viruses
- Testing for viruses in unprocessed bulk
- Virus validation studies
Dr Sabine Häcker / Dr Barbara Enenkel
Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach
Head Virus Test / Senior Associate Director Bioprocess and Analytical Development
Upstream development (early and late stage)
Live webcast on 9 April 2019, 14.00 (CET)
- Process characterisation
- Fermentation development
- Scale-up and scale-down approaches
Dr Markus Michael Müller
Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach
Associate Director of Cell Culture Development CMB
Downstream development (late stage)
Live webcast on 14 Mai 2019, 14.00 (CET)
- Late stage development
- Stage I validation
Jessica Stolzenberger
Boehringer Ingelheim Pharma GmbH & Co. KG,
Head of Laboratory, Late Stage DSP Development
Pharmaceutical Development of Biologics Drug Products: the interface of formulation, primary packaging and application
Live webcast on 4 June 2019, 14.00 (CET)
- Protein stability challenges and ways to address by formulation
- Special topic : particles, particles everywhere
- Special topic : surfactants – the good, the bad and the ugly
- Container closure system compatibility
- Challenges in the development and application of highly concentrated formulations
- Challenges in the application of low clinical doses
Dr Susanne Jörg
Lonza AG
Head of Formulation Development, Drug Product Services
Bioassays
Live webcast on 2 July 2019, 14.00 (CET)
- why are they needed?
- advantages/disadvantages of bioassay setups
- replacement of bioassays
- requested -
Dr Katrin Buss
Expert for pharmaceutical Quality and Regulatory Affairs, Bonn
Stability concept: pre and post launch
Live webcast 28 August 2019, 14.00 (CET)
- Stability programmes
- Use of bracketing/matrixing
- Extrapolation of the shelf life
- Stress stability studies
- Stability indicating methods
- Container closure integrity testing
Dr Rainer Ilg
Boehringer Ingelheim Pharma GmbH & Co. KG
Senior Associate Director, Global Technical Regulatory Affairs
Comparability – Similarity assessment
Live webcast on 17 September 2019, 14.00 (CET)
- Differences and common features
- Assessment of critical quality attributes
- Demonstration of analytical comparability
- during development
- during changes in the manufacturing process
- tech transfer and challenges
- Demonstration of analytical similarity
- Different approaches to show similarity in US and EU
- Justification of differences
Dr Manuel Wittner, Associate Director, Global Technical Regulatory Affairs
Dr Beatrix Metzner, Head of Global Technical Regulatory Affairs
Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach
CMC Life Cycle Management: ICH Q12 and others
Live webcast on 15 October 2019, 14.00 (CET)
- Post-approval change management protocol (PCMP)
- How to achieve regulatory flexibility?
- Requirements regarding tech transfer
Dr Steffen GroßPaul-Ehrlich-Institut (PEI), Langen
'Data exclusivity: specific characteristics for biologics/biosimilars'
Live webcast on 27 November 2019, 14.00 (CET)
- Post approval change management protocol (PCMP)
- How to achieve regulatory flexibility?
- Requirements regarding tech transfer
Prof. Burkhard SträterPartner, Sträter Lawyers, Bonn
