PDA Letter Article

Can the Power of Viruses be Harnessed for Good?

by Brian Hawkins, PhD, Pluristyx, Inc.


Viruses are ubiquitous agents that can infect all forms of life and result in genome alterations that kidnap host cells and outwit immune defenses.

Medical advances, however, have enabled researchers to harness the unique qualities of viral genome editing, resulting in genetically modified cells that can synthesize biopharmaceuticals or even act as “living drugs” to attack and eradicate chronic diseases such as cancer.

As biopharmaceuticals continue to advance, what role will viruses play in the production of innovative therapies? And as researchers use viruses to produce living drugs, how can patient safety be assured?

PDA will host the 2019 PDA Virus Safety Forum. This one-day event begins with a breakfast session highlighting the work of PDA’s Advanced Virus Detection Interest Group and extended discussion on current advances in viral testing, mitigation and clearance. A panel discussion will focus on the practical application of viral safety protocols in biopharmaceutical manufacturing.

Following the breakfast session, plenary sessions will feature expert talks on a comprehensive virus safety strategy that includes testing, mitigation and clearance of adventitious viral agents. Commonly referred to as the “safety tripod,” testing, mitigation and clearance will be addressed as part of a risk-based approach to viral safety, with presentations addressing the use of qualified raw materials, the detection of both known and unknown viral agents, incorporation of viral manufacturing controls, the relative merits of conventional assay and methods to inactivate or remove viral particles from finished product. Incorporation of these manufacturing controls can dramatically reduce the negative impact of adventitious viral particles and provide a robust platform to improve the safety of biopharmaceutical products.

Learn more about the 2019 PDA Virus Safety Forum.