Development and Release of a Successful Biologic
Join us on Thursday, November 15, 2018, from 9 a.m. – 2 p.m.
at KingsWood Hotel Citywest, Naas Rd, Kingswood, Dublin 22, Ireland
Ensuring the safety and efficacy of your biologic should be topmost in your mind, coupled with meeting your timelines and budgetary limitations. Join us as we discuss some of the parts that go into the development and release of a biological product. First, we will look at microbial risk management; included in these discussions will be disinfectant efficacy testing, microbial challenge studies, and identification of microbial contaminants in your facilities. Bioactivity assays, different types and uses, will be discussed next and we will round out the seminar with a discussion around successful product release and regulatory updates including the EU/US mutual recognition agreement and the potential impacts of Brexit that could affect the release testing of your product in the coming years. Join us in November and end your year gaining knowledge to jump start your development efforts in 2019.
- Considerations for Successfully Selecting and Implementing a Rapid Micro Method
Brice Chasey, Sr. Product Manager
- Managing Product Release to Global Markets
Niall Dinwoodie, Senior Director, Product Characterization
- Mechanism of Action (MoA) Reflecting Bioactivity Assays for Lot Release, Stability Testing, and Beyond
Dr. Ulrike Herbrand, Scientific Director, Global In Vitro Bioassays
- Microbial Risk Management: Efficacy of Disinfectants and Microbial Challenge Testing
Joan O’Malley, Manager of Microbiology
- Virus Safety Testing for Cell Derived Recombinants
Dr. Horst Ruppach, Global Manager, Viral Clearance and Viral Safety
*Presentations subject to change