2021 PDA Virus Conference

Regulatory Updates
The first version of ICH Q5A was published in 1997 to regulate the Viral Safety Evaluation of Biotechnology
Products Derived from Cell Lines of Human or Animal Origin, then with a focus on interferons, monoclonal antibodies and recombinant DNA-derived products. A quarter of a century later, cell- and gene-based products, i.e. advanced therapies, now hold the promise of transforming medical practices, potentially offering cure rather treatment of medical conditions. The regulatory framework to support making theses advancements of biomedical research available to patients at adequate virus safety margins will be discussed.

Applications of Next Generation Sequencing, New Technologies, and Virus Detection
Adventitious viral contaminants are a major safety concern for biopharmaceutical manufactures; therefore, biopharmaceutical products undergo extensive adventitious agent testing to ensure that they are free of viral contamination. Traditional adventitious viral testing involves the use of cell culture or animals to detect viral contamination.  More recently, molecular techniques have been developed to detect adventitious virus yielding faster turnaround times and broader viral detection than the traditional methods.  In this session we will hear about molecular techniques such as next generation sequencing, and their potential to replace or supplement traditional adventitious virus tests.

Moderators:
Sean O’Donnell, Eli Lilly & Company
Arifa Khan, U.S. FDA

Advanced Virus Detection Interest Group (AVDTIG) Session
The AVDTIG is an international effort focused on standards and standardization of next generation sequencing technologies for adventitious virus detection in biologics. The group has scientific discussions and collaborations to address technical and bioinformatics challenges in the NGS workflow, with the goal of facilitating broad applications of NGS for viral safety.  The session will include brief presentations on the background, ongoing activities, and achievements of the IG, and the status of ongoing collaborative studies for evaluating virus detection using NGS. The session will close with a member panel for audience Q&A and discussion. 

Moderators:
Arifa Khan, U.S. FDA
Jean-Pol Cassart, GSK Vaccines

Viral Inactivation & Removal
Virus clearance remains one of the key pillars supporting the virus safety of biological products. There is much we are still learning about what constitutes a robust virus removal or inactivation step. In this session we will gain insights into one of the key steps, virus filtration, both from a regulatory as well as a mechanistic perspective. Much can also be gleaned from data mining, and the FDA Office of Biotechnology Products database provides a unique insight into which steps have demonstrated robust and effective clearance over a wide range of products. Additional mechanistic insights into the partitioning of viruses over anion exchange chromatography can help in optimizing specific chromatography steps for the effective removal of even parvoviruses.  

Considerations on Continuous Processing and Facility Design
Continuous processes offer the potential to transform the manufacture of biotherapeutic products through improvements to efficiency, cost and quality. Likewise, recent considerations to facility design, some including continuous manufacturing concepts, propose similar benefits to availability and quality of biopharmaceuticals.  This session reflects on challenges such as small-scale validation, explores unique risk profiles of the presented facility designs and looks into the use of modular and prefabricated manufacturing environments. 

Moderators:
Alison Armstrong, Merck KGaA
Sebastian Teitz, Asahi Kasei

Learnings from the Pandemic for Viral Safety
The SARS -CoV-2 pandemic showed how important it is to have safety barriers in place, up-front before a new virus emerges.  In this session we will learn how sate of the art technologies including next generation sequencing and in-depth experience with plasma proteins has assisted the pharmaceutical industry in ensuring viral safety of biological medicinal products as well as rapidly developing active and passive immunization.

Moderators:
Johannes Blümel, Paul-Ehrlich-Institut
Andy Bailey, ViruSure