Deliver Consulting Limited | Back to main site
More

Program Overview

The risk of adventitious viral contamination is common to most of all biotechnology products derived from cell lines of human or animal origin as well as plasma/plasma-derived medicinal products and also such contamination could possibly elicit serious clinical consequences. Therefore, it is expected the viral safety of medicinal products shall be reasonably assured through the application of a rigorius virus testing program and robust assessment of virus removal and inactivation achieved through the manufacturing and purification process. And based upon the first two years' program, through collaborating with KOLs, the third PCA2015 forum aims to build up and facilitate the progressive regulatory, scientific and technical communication to advocate the Safety and Quality profiles of bio-therapeutics in the region.

More

2015 Speaker Committee

  • Kurt Brorson

    Lab Chief (Acting),Division of Biotechnology Research and Review II, Office of Biotech Products, CDER
    US. Food and Drug Administration
  • Sally Baylis

    Scientific Assessor, Division of Virology
    Paul-Ehrlich-Institut
  • Keisuke Yusa

    Chief, Section of Viral Safety, Division of Cell-Based Therapeutic Products
    National Institute of Health Sciences Japan
  • Ywan-Feng Li

    Director, Division of Pharmaceutical Science
    Center for Drug Evaluation, Taiwan
  • Ivar Kljavin

    Director, Adventitious Agents & Critical Reagents Management
    Genentech, A Member of the Roche Group
  • Rosemary Versteegen

    Chief Executive Officer
    International Serm Industry Association
  • Prof. Limin Chen

    Professor, Director and Chief Scientific Officer, Center for Transfusion Transmitted Infectious Diseases, CAMS/PUMC; Toronto General Research Institute, University of Toronto
    Institute of Blood Transfusion/CAMS/PUMC and the University of Toronto
  • Prof. Dr. Dr. Rolf G. Werner

    Professorship for Industrial Biotechnology
    Eberhard Karls University of Tuebingen, Germany
More

Program Key Discussions

Current Regulatory Perspectives and Requirements on Virus Safety
Raw and Starting Materials Risk Assessmen and Characterization
Risk and Regulatory Consideration to Implement the Novel Cell Substrates
Preparation and Quality Control of Virus Spike
Adventitious Viral Detection and Novel Methods
Viral Clearance Studies
Assessment on Unit Operation of which the MoA is not fully understood
Viral Clearance throughout Product Development
Viral Safety for Plasma and Plasma Derivatives
Quality by Design in Virus Safety
Issues and Strategies with HEV, PCV, TSE and Mycoplasma Contamination

More

Who should Attend

More than 120 Participants are expected to attend 'Pathogen Clean Asia Summit 2015',  The participants will mainly come from the Biotechnology Corporate, Blood Products Manufacturers, Regulatory Agencies, Contract Testing/Research Organizations, Contract Manufacturing Organizations, Cutting-edge Purification and Filtration Systems with the main responsibilities including but not limited to:

Process Development and R&D
Downstream Purification and Viral Validation
Quality Assurance and Management
Viral/Pathogen Safety Assessment
Microbiologists
Regulatory and Scientific Review