2023 PDA Virus Conference

9:00

Welcome and Introduction
Falk Klar, PDA
Alison Armstrong, Merck KGaA
Andy Bailey, ViruSure

11:45 - 13:15 I Session 1: Viral Clearance
Moderator: Tomoko Hongo-Hirasaki, Asahi Kasei and Sebastian Teitz, Biopharma Excellence

Within the basic concept of ICH Q5A which is commonly referred to as the “Virus Safety Tripod of Biopharmaceuticals”, the pillar of virus clearance typically contributes the largest proportion in risk reduction to the biopharmaceutical product. This session will explore new approaches toward the measurement and detection of virus particles in the context of virus clearance studies and dive into the implementation and validation of virus filters into continuous processes.

14:30 - 16:00 I Session 2: Round Table Discussions
Moderator: Johannes Blümel, Paul-Ehrlich-Institut,

With the recently published draft revision of ICH Q5A, four main topics with a major impact on the viral safety strategy have been identified. The revision opens the possibility to use prior knowledge for validation of viral clearance. The scope of ICH Q5A will be extended towards new product types such as certain viral vectors and testing for residual helper viruses used at vector production. Last but not least, the revised draft guideline acknowledges the recent advances in using next-generation sequencing for virus detection and the possibility of revising the adventitious agents testing strategy. Participants are invited to join specific subgroups to discuss their questions in an open scientific environment. Outcomes will be presented by the moderators to all participants.

16:30 - 17:50 I Session 3: Virus Detection
Moderator: Andy Bailey, ViruSure

The ICH Q5A document promotes the wider application of Next Generation Sequencing (NGS) and PCR-based technologies for the detection of potential virus contamination. This session will explore how NGS can be effectively implemented in any adventitious agent testing program and how this technology compares with more traditional, infectivity-based, approaches. Demonstrating that NGS has the sensitivity for a broad range of potential contaminants is key and the presentations will present case studies addressing these key aspects.

9:05 - 10:20 I Session 4: Next Generation Sequencing - Efforts in the Advanced Virus Detection Interest Group (AVDTIG)
Moderator: Alison Armstrong, Merck KGaA

The AVDTIG is a multidisciplinary international effort with a focus on developing standards and conducting collaborative studies for performance evaluation and qualification of NGS technologies for adventitious virus detection in biologics. The session will provide background, ongoing activities, and achievements of the Interest Group, and the status of ongoing collaborative studies for evaluating virus detection using short-read and long-read NGS technologies. Details of two spiking studies, which are completed/near completed, will be presented. The session will close with audience Q&A and discussion.

10:50 - 12:10 I Session 5: Manufacturing-Related Aspects
Moderator: Sean O'Donnell, Eli Lilly and Company

Biopharmaceutical manufacturers are continually looking for ways to rapidly detect and prevent adventitious virus contamination and remove endogenous viruses in the manufacturing processes. High-Temperature Short Time (HTST) is a common method that is employed by manufacturers to inactivate any potential contamination in cell culture media and feeds, but implementation can be costly and take a lot of development time. In this session, the use of upstream virus filters to remove viral contamination from media and feeds will be discussed. Also, the use of PCR to detect endogenous viral loads in unprocessed bulk harvests and Xenotropic murine leukemia virus (X-MuLV) removal during the Protein A column chromatography unit operation will be discussed.