Online PharmaTalk 2/2021

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Friday, May 7, 2021
  • Speaker: Ashutosh Rao, Ph.D., Center for Drug Evaluation and Research, U.S. Food and Drug Administration
  • Topic: «Scientific and regulatory perspectives on control strategies for excipients in biotechnology drugs»
  • Date, time: Fri May 7, 2021, 14:00 – 15 h
  • Mode: Online Webinar, Zoom link
  • Abstract: Surfactants and other excipients are an integral component of biotechnology drug products. Consequently, optimal formulation and control of excipients are key aspects of an overall control strategy by drug manufacturers aimed at consistent product quality, safety, and efficacy. Evolving evidence suggests that certain surfactants are susceptible to degradation and particulate formation in protein formulations; although, the root cause, biochemical drivers of degradation, and impact to the product and patient remain unresolved questions.  The regulatory basis for the U.S. FDA’s expectations on the quality and analysis of excipients during drug development is primarily derived from 21 CFR 211.84(6)(d)(2). The overall control strategy and other information submitted by the drug developer is generally expected to address unreasonable and significant risk of illness or injury to human subjects as well as to provide sufficient information to allow regulators to assess potential risk to human subjects. This presentation will cover (1) the current scientific and regulatory rationale for using and controlling surfactants in protein formulations, (2) a pragmatic overview of the risk from surfactant degradation, (3) orthogonal strategies for controlling surfactant, host cell proteins, and related product quality attributes such as particulates in therapeutic proteins, (4) the types of studies that generally support the safe use of surfactants in protein formulations, and (5) the desired state of surfactant and related product quality attributes.


Mr Business Development Tschopp, Glatt Pharmaceutical Services GmbH & Co. KG
Prof. Oliver Germershaus, School of Life Sciences - University of Applied Sciences NW Switzerland
Prof. Gerrit Borchard, Université de Genève
Dr Christine Moll, SAPhW
Dr Burkhard Kriwet, Vifor Pharma
Dr Josip Matic, RCPE GmbH
Prof. Mahler Hanns-Christian, Bionter AG
sammina ahmed, Lonza Biologics
Dr Danny Chou, Compassion Bio
Dr Leonardo Rosado, Genmab
Dr Dhananjay Jere, Lonza
Dr Andrea Hawe, Coriolis Pharma
Dr Reza Esfandiary, Astrazeneca
Dr Salem Seif, Bilim Pharmaceuticals
Mr Jeremy Duboeuf, Roche AG
Mrs Delphine MATHIEU, Sanofi
Dr Yun Liu, Spark Therapeutics
Aimilia Avgerinou, Lonza
Dr Beatrix Oppenberg, NovaGo Therapeutics
Mr Jens Hetzel , BMS
Dr Jonas Fast, F. Hoffmann- La Roche
Dr Stefan Leitgeb, Private
Dr Clara Ferloni, Lonza AG
Georgios Imanidis, School of LIfe Sciences - FHNW / University of Basel
Mrs Katharina Bruno-Thakur, F. Hoffmann La Roche AG
Dr Felix Ditzinger, F.Hoffmann-La Roche
Dr Magdalena Swiderska, Private
Dr Nicole Germershaus, Swedish Orphan Biovitrum
Prof. Rudolf Brenneisen, SAPhW
Mr tao liu, Merck group
Prof. Paola Luciani, University of Bern
Dr Maria Fernanda Zuluaga Estrada , Evonik
Prof. Dashnor Nebija, University of Prishtina/Pharmaceutical Chemistry/
Andrea Lindemann, Lonza
Prof. Jörg Huwyler, Universität Basel
Dr Elisabeth Grimm, Dr. Grimm Bättig Consult
Dr Silvana Di Cesare, Lonza
Dr Nadine Ritter, Global Biotech Experts
Dr Ravishankar Vadali, Aruvant
Dr Julia Maier, Lonza
Mr Martin Hillebrandt, Lonza
Umair Saleheen, MBBS, N/A
Dr Benoite Kaeser, SAPhW
Stephan Schmitt-Koopmann, sk pharma consulting GmbH
Dr Dieter Scherer, ApisPharma
Grubisic Slaven, BMS
Dr Gregoritza Kathrin , F. Hoffmann La Roche
Mr Christos Theodorou, F. Hoffmann-La Roche
Dr Christina Häuser, F. Hoffmann-La Roche
Dr Manuel Gregoritza, F. Hoffmann-La Roche Ltd